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Psychosocial interventions for men with prostate cancer

  1. Kader Parahoo1,*,
  2. Suzanne McDonough2,
  3. Eilis McCaughan1,
  4. Jane Noyes3,
  5. Cherith Semple4,
  6. Elizabeth J Halstead5,
  7. Molly M Neuberger6,
  8. Philipp Dahm6,7

Editorial Group: Cochrane Urology Group

Published Online: 24 DEC 2013

Assessed as up-to-date: 1 OCT 2013

DOI: 10.1002/14651858.CD008529.pub3


How to Cite

Parahoo K, McDonough S, McCaughan E, Noyes J, Semple C, Halstead EJ, Neuberger MM, Dahm P. Psychosocial interventions for men with prostate cancer. Cochrane Database of Systematic Reviews 2013, Issue 12. Art. No.: CD008529. DOI: 10.1002/14651858.CD008529.pub3.

Author Information

  1. 1

    University of Ulster, Institute of Nursing and Health Research, Coleraine, UK

  2. 2

    University of Ulster, Health and Rehabilitation Sciences, Newtownabbey, Co Antrim, UK

  3. 3

    Bangor University, Centre for Health-Related Research, Fron Heulog, Bangor, Wales, UK

  4. 4

    South Eastern Health & Social Care Trust, Cancer Services, Belfast, Northern Ireland, UK

  5. 5

    Bangor University, School of Healthcare Sciences, Bangor, Gwynedd, Wales, UK

  6. 6

    University of Florida, Department of Urology, Gainesville, Florida, USA

  7. 7

    Malcom Randall Veterans Affairs Medical Center, Gainesville, Florida, USA

*Kader Parahoo, Institute of Nursing and Health Research, University of Ulster, Coleraine, BT52 1SA, UK. ak.parahoo@ulster.ac.uk.

Publication History

  1. Publication Status: New
  2. Published Online: 24 DEC 2013

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Characteristics of included studies [ordered by study ID]
Ames 2011

MethodsStudy design: randomised controlled trial

Follow-up: week nine (end of treatment) and six months post-treatment


ParticipantsFifty-seven men at the biochemical recurrent stage of prostate cancer were randomly assigned to an intervention (n = 30) or to a control group (n = 27). The median age of participants was 76 years. The ethnic composition was 89% white, 10% black and 1% other

Eligibility criteria included men ≥ 18 years old, expected survival ≥ one year, a diagnosis of prostate cancer with prostate-specific antigen (PSA) recurrence post-surgery or post-radiation without clinical or X-ray evidence of metastases and a Mini-Mental Status Examination score ≥ 24. Participants were recruited from two medical centres in Northeast Florida, USA


InterventionsThe multidisciplinary quality of life intervention (MQOL) consisted of eight weekly group sessions, each lasting one hour. As well as providing information regarding prostate cancer, the sessions dealt with goal setting, problem solving, relaxation training, nutrition, physical activity and conditioning, mood management, social support and maintenance of positive health behaviour. The sessions were delivered mainly by a clinical health psychologist with input from a medical oncologist, a dietician and a psychiatrist, as appropriate

Control group participants did not receive any form of quality of life intervention during the study period but were offered the MQOL following completion of the study


OutcomesQuality of life (general healthrelated)

MOS 36-Item Short Form Survey (SF–36)

Quality of life (prostate cancerspecific)

Functional Assessment of Cancer Therapy–Prostate (FACT-P)


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskMethod of randomisation not given

Allocation concealment (selection bias)Unclear riskNot stated

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot stated

Incomplete outcome data (attrition bias)
All outcomes
High riskNumber of participants in each group at follow-up time points not given

Selective reporting (reporting bias)Low riskAll outcome data reported

Other biasLow riskNone

Bailey 2004

MethodsStudy design: randomised controlled trial

Follow-up: 10 weeks post-baseline (five weeks after intervention was completed)


ParticipantsForty-one men were randomly assigned to an intervention group (n = 21) or a control group (n = 20). Thirty-nine men, with a mean age of 75.4 years, completed the study at 10 weeks post-baseline. Eighty-six per cent were Caucasian and 14% African American. Most had T1 or T2 tumours (97%). Inclusion criteria were patients with a diagnosis of B1, B2 and C1 prostate cancer who had elected watchful waiting in consultation with their physician, with watchful waiting time from one to 124 months. Participants were recruited from a central hospital in North Carolina, USA


InterventionsThe intervention consisted of five weekly telephone calls by a male nurse, lasting an average of 13 minutes (range five to 26 minutes). The intervention, which was tailored to each participant's needs, was designed "to help men integrate uncertainty into their lives by teaching them to cognitively reframe the way in which they viewed their illness and the uncertainty it produced" (p. 341). The intervention had four components. The first encouraged participants to reframe uncertainty in a positive light. The second helped participants to incorporate uncertainty into their life structure. The third was designed to support participants’ belief that future treatment would be better. Finally, the fourth component encouraged self-monitoring and vigilance. Information about the disease and about treatment was given

Participants in the control group received usual care and "had access to naturally occurring sources of support" (p. 341)


OutcomesQuality of life

Two items asking respondents to rate their current quality of life and the quality of life they expect in six months, on a scale of zero to 10


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskUsed a table of random numbers

Allocation concealment (selection bias)Unclear riskNot stated

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot stated

Blinding of outcome assessment (detection bias)
All outcomes
High risk"data collectors did not deliver the intervention but were aware of group assignment at the time of enrollment" (p. 342)

Incomplete outcome data (attrition bias)
All outcomes
Low riskMissing data accounted for

Selective reporting (reporting bias)Low riskAll data outcomes reported

Other biasLow riskNone

Berglund 2007

MethodsStudy design: randomised controlled trial

Follow-up: six months and 12 months post-baseline


ParticipantsTwo hundred eleven men with prostate cancer were randomly assigned to one of the following four groups: physical training (n = 53), information (n = 55), physical training and information (n = 52) and control (n = 51)

One hundred fifty-eight completed the study at 12 months post-baseline. The number that completed in each group was 34 in physical training (Phys), 46 in information (Info), 42 in physical training and information (Phys and Info) and 36 in control. The average age of participants was 69 years, with a range of 43 to 86 years. No ethnic composition of the sample was given. The inclusion criterion was six months after diagnosis of prostate cancer. Overall, 20% of the final sample had metastasis. Patients were excluded if they had severe hearing or vision impairment, were not Swedish speaking or were physically and mentally disabled. Participants were recruited from a university hospital in Uppsala, Sweden


InterventionsThe physical training group (Phys) met weekly for seven weeks. A physiotherapist led 60-minute physical training sessions (movement and fitness training, relaxation, breathing exercises and pelvic floor exercises). A booster session was held every two months after the conclusion of the training exercises. Opportunities were provided to discuss exercises and ‘other important issues’

The information (Info) group, led by a nurse, consisted mainly of sharing information on prostate cancer and its treatment and side effects. Opportunities were provided to discuss with the group leader participants' experiences regarding diagnosis and communication. Each session lasted 60 minutes and was delivered once weekly for seven weeks

The information plus physical training (Phys and Info) group, which lasted 135 minutes, took place once weekly for seven weeks and was a combination of the Phys group and Info group programmes. Physical training was given before the information session was held

The control group received standard care. Participants received information, which consisted of two leaflets. They also had the opportunity to phone a nurse if they had any questions but did not partake in group information or in physical training


OutcomesDepression

14-Item Hospital Anxiety and Depression Scale (HADS)

Quality of life (cancer-related)

EORTC QLQ-C30 version 3.0


NotesThe non-completion rate was 25.1% at one year post-baseline, resulting in an even smaller sample size in the three comparison groups and the one control group


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskConsecutive "patients were randomly assigned to one of four groups" (p. 84)

Method of randomisation not explained

Allocation concealment (selection bias)Unclear riskNot stated

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants informed of group assignment; consequently some dropped out

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot stated

Incomplete outcome data (attrition bias)
All outcomes
Low riskMissing data explained

Selective reporting (reporting bias)High riskData on depression and quality of life collected at six months and not reported

Other biasHigh risk"in addition to relatively small randomisation groups at the beginning, 20% of the patients dropped out during the first year of the study, which resulted in decreasing power at each assessment period" (p. 88)

Campbell 2007

MethodsStudy design: randomised controlled trial

Follow-up: six weeks post-intervention


ParticipantsForty men were randomly assigned to an intervention group (n = 20) or a control group (n = 20). Thirty men completed the study (12 in the intervention group and 18 in the control group). All participants were African Americans with a mean age of 60.9 years (SD 8.0) in the intervention group and 62.9 years (SD 9.7) in the control group. Ninety-three per cent had undergone radical prostatectomy. Eligibility criteria were African American men who were beyond the acute diagnosis and treatment phase for prostate cancer and with a Karnofsky Performance Status score ≥ 60, along with their identified intimate partners. Participants were recruited from a urology clinic in North Carolina, USA


InterventionsThe intervention was a telephone-based educational intervention designed to teach cognitive and behavioural techniques that increase self-efficacy for symptom management, which can reduce symptom severity and emotional distress. The protocol consisted of providing information about prostate cancer and side effects and teaching problem-solving skills and specific cognitive and behavioural coping skills (e.g. communication skills, relaxation training, activity pacing). The intervention, which was delivered by African American doctoral level medical psychologists, lasted one hour each week for six weeks

The control group received routine care provided through the medical outpatient programme


OutcomesSelf-efficacy

Self-efficacy for Symptom Control Inventory (SESCI)

Quality of life (symptom-related)

50-Item Expanded Prostate Cancer Index Composite (EPIC)

Quality of life (general healthrelated)

Short Form Health Survey (SF-36)


NotesDescribed as a pilot study by the authors. Dropout rate was 25% overall and 40% in the intervention group. The intervention was also delivered to men with prostate cancer and their intimate partners


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskUsed a 'computerized random number generator' (personal correspondence)

Allocation concealment (selection bias)Low riskUsed 'opaque sealed envelopes' (personal correspondence)

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot stated

Incomplete outcome data (attrition bias)
All outcomes
Low riskMissing data reported

Selective reporting (reporting bias)Low riskAll outcome data reported

Other biasHigh riskHigher attrition rate in the psychosocial intervention group (40%) compared with the control group (10%)

Carmack Taylor 2006

MethodsStudy design: randomised controlled trial

Follow-up: six and 12 months post-intervention


ParticipantsOne hundred thirty-four men with prostate cancer were randomly assigned to one of three groups: lifestyle programme (n = 46), educational support programme (n = 50) and a standard care group (n = 38). One hundred thirteen completed the programme (35 in lifestyle programme, 44 in educational support programme and 34 in standard care). The average age of participants was 69.2 years (range 44.8 to 89.0 years), and ethnic composition was 73.1% white, 20.1% African American and 6.7% ‘other’. Recruited participants resided within one hour travelling distance from a cancer centre in Texas, USA. Eligibility criteria included men with a diagnosis of prostate cancer, regardless of stage, who were receiving continuous androgen ablation therapy with the expectation to continue therapy for one year and be able to speak and understand English. Exclusion criteria were participating in 30 minutes of purposeful physical activity (three or more times a week for six months) and conditions for which physical activity would be contraindicated. At baseline, participants had been on androgen ablation therapy for an average of 32.7 months. No details on stage of prostate cancer were reported


InterventionsThis study tested two psychosocial interventions: the lifestyle programme (LP) and the educational support programme (ESP). Participants were compared with a standard care (SC) group. Participants in the LP and ESP attended small group meetings (approximately eight men) for six months. Both programmes included an orientation session, 16 weekly sessions and four bi-weekly sessions, each lasting 1.5 hours. The LP aimed to build self-efficacy and cognitive behavioural skills to adapt and maintain regular physical activity. Each session covered a specific cognitive behavioural skill for increasing physical activity, including self-monitoring, goal setting, problem solving, overcoming barriers, cognitive restructuring and rewarding oneself. The ESP consisted of a series of preestablished questions covering topics such as diet and prostate cancer, side effects of androgen ablation and sexuality. This programme used a discussion format but provided neither skills training nor instructions on behaviour to improve quality of life. The LP and the ESP were led by group facilitators supervised by a licensed clinical psychologist

Participants in the standard care group did not attend group support meetings but received one mailing of educational material about community resources. These materials were also given to participants in the intervention groups


OutcomesQuality of life (general healthrelated)

36-Item MOS Short Form Health Survey (SF-36)

Depression

Center for Epidemiological Studies-Depression (CES-D)


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskMinimisation used

Allocation concealment (selection bias)Unclear riskNot stated

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot stated

Blinding of outcome assessment (detection bias)
All outcomes
Low risk"Research staff conducting assessments were blind to the participants' study program assignment" (p. 851)

Incomplete outcome data (attrition bias)
All outcomes
Low riskMissing data explained

Selective reporting (reporting bias)Low riskAll outcomes data reported

Other biasLow riskNone

Chambers 2013

MethodsStudy design: randomised controlled trial

Follow-up: two, six, 12 and 24 months post-treatment


ParticipantsSeven hundred forty men, newly diagnosed with localised prostate cancer, were randomly assigned to an intervention group (n = 372) or a usual care group (n = 368). The ethnic composition was not given in the paper. From personal correspondence, the following data were obtained: most of the sample (85%) were of "British/Scottish/Welsh/Irish descent; the remainder were of European, Asian, or other ethnic background"

Eligibility criteria were newly diagnosed with localised prostate cancer, suitable for treatment with curative intent, with no evidence of metastatic disease on scan/X-rays; able to read and speak English; with no history of head injury, dementia or psychiatric illness and no other concurrent cancer. Participants were recruited from the geographic areas of South East and North Queensland, Australia


InterventionsThis psychoeducational, telephone-delivered intervention consisted of elements such as decision support, challenging unhelpful conditions, psychoeducation about adjustment to prostate cancer, stress reduction techniques and coaching about problem-solving skills for side effects associated with prostate cancer treatments

The intervention was delivered by nurse counsellors in five sessions: two pretreatment sessions, two sessions at three and seven weeks post-treatment and a final booster session five months after treatment

The usual care group received standard medical management and no other support apart from a small set of already widely available patient education materials delivered by mail


OutcomesQuality of life (general healthrelated)

Short Form Survey (SF-36)

Quality of life (symptom-related)

UCLA Prostate Cancer Index (EPIC)

Distress

Revised Impact of Events Scale (RIES)

Uncertainty

Decisional Conflict Scale-Revised


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskBlock randomisation

Allocation concealment (selection bias)Low riskSequence undertaken by project manager and concealed from investigators

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskParticipants and counsellors aware of who were receiving the intervention

Blinding of outcome assessment (detection bias)
All outcomes
Low riskAssessors blinded to condition

Incomplete outcome data (attrition bias)
All outcomes
Low riskMissing data explained

Selective reporting (reporting bias)Low riskAll outcomes reported

Other biasLow riskNone

Davison 1997

MethodsStudy design: randomised controlled trial

Follow-up: five to six weeks post-baseline


ParticipantsSixty men newly diagnosed with prostate cancer were randomly assigned to an intervention group (n = 30) or a control group (n = 30). Selection criteria included having been told their diagnosis, not having had their initial treatment consultation, able to read, speak and write English and no evidence of mental confusion. The mean age of participants was 67.9 years. All were recruited from one community clinic in Winnipeg, Canada. No details were provided on the ethnic composition of the sample nor on the stage of their cancer, although participants were in the newly diagnosed phase


InterventionsThe intervention was based on an empowerment model aimed at increasing self-efficacy in seeking information and making treatment decisions. It consisted of the provision of a written information package containing various types of information about prostate cancer. With the help of a nurse, participants in the intervention group identified the information they needed to assist them in deciding which treatment would be best for them. Additional questions that arose out of the discussion between the participant and the facilitator were added to the list

Participants in the control group received the same information package without the opportunity to discuss their information needs with a facilitator


OutcomesDepression

Center for Epidemiological Studies Depression Scale (CES-D)


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomisation method not described

Allocation concealment (selection bias)Unclear riskNot stated

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot stated

Incomplete outcome data (attrition bias)
All outcomes
Low riskMissing data accounted for

Selective reporting (reporting bias)Unclear riskAll outcome data reported but full statistical results for depression not presented

Other biasLow riskNone

Giesler 2005

MethodsStudy design: randomised controlled trial

Follow-up: four, seven and 12 months post-baseline


ParticipantsNinety-nine men, diagnosed with prostate cancer and within six weeks post-treatment, were randomly assigned to an intervention group (n = 48) or a control group (n = 51). Fourteen participants dropped out at 12 months. Eligibility criteria were men with a diagnosis of stage T1a to T2c prostate cancer; scheduled to undergo or to have undergone surgery, external beam radiation or brachytherapy; 18 years or older and having a spouse or partner willing to participate in the trial. Most participants were Caucasian (n = 87; 90%). Eight per cent (n = 8) were African American. Participants were recruited from Indiana, Michigan and Louisville in the USA. Mean age of participants was 63.8 years


InterventionsThe intervention focused primarily on issues related to sexual, urinary and bowel dysfunction, anxiety, relationship adjustment, depression and other common sequelae of cancer. The intervention was delivered by a nurse, whose task consisted of assessing participants’ problems or concerns, helping them identify strategies to address them and monitoring progress with the use of a laptop computer. Intervention visits took place once a month for six months. The first two visits were in person and the other four were over the telephone

Control group participants received standard care. No further detail was provided


OutcomesDepression

20-Item Center for Epidemiological Studies-Depression Scale

Quality of life (general healthrelated)

Short Form Health Survey (SF-36)

Quality of life (prostate cancer)

Prostate Cancer Quality of Life Instrument (PCQoL)


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskFlip of a coin (personal correspondence)

Allocation concealment (selection bias)High risk"No concealment because the group participants had been assigned to was obvious to all" (personal correspondence)

Blinding of participants and personnel (performance bias)
All outcomes
High riskSee above

Blinding of outcome assessment (detection bias)
All outcomes
Low riskAssessors were blind to group assignment

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskDid not provide the number of participants at each follow-up time point for each group

Selective reporting (reporting bias)Unclear riskDid not give overall scores for each group on prespecified outcomes

Other biasLow riskNone

Lepore 2003

MethodsStudy design: randomised controlled trial

Follow-up: two weeks, six months and 12 months post-intervention


ParticipantsTwo hundred seventy-nine men with prostate cancer were randomly assigned to a 'group education' intervention, a 'group education plus discussion' intervention or a control group. The number allocated to each group was not provided. Twenty-nine men (10.4%) did not complete the study. The number of participants (n = 250) who completed the study in each group was as follows: 'group education' intervention: n = 84; 'group education plus discussion' intervention: n = 86; and control: n = 80. The final sample comprised 226 (90.4%) Caucasians, 23 (9.2%) African Americans and one Asian American. Most of these men were at the T2 stage of prostate cancer (n = 173; 69.2%). The rest were at T1 (n = 45; 18%) and T3 (n = 32; 12.8%). All had recently completed treatment before enrolment in the study. They were recruited from 11 Greater Pittsburgh area urology and radiology clinics and hospitals


InterventionsThe two interventions, education group (GE) and education plus discussion group (GED), consisted of six sessions (one hour each week). The GE group received lectures on a range of prostate cancer–related topics from experienced health professionals. Lecturers allowed 10 minutes for questions, but participants were not encouraged to talk with one another. The GED group received the lectures plus 45 minutes of group discussion facilitated by a clinical psychologist. Participants in the control group received nothing beyond their standard medical care


OutcomesProstate cancer knowledge

13-Item investigator-developed questionnaire

Quality of life (general healthrelated)

Short Form Survey (SF-36)

Quality of life (symptom-related)

UCLA Prostate Cancer Index

Depressive symptoms

Center for Epidemiological Studies-Depression Scale (CES-D)


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskActual method of randomisation not stated

Allocation concealment (selection bias)Low risk"After the baseline interview, participants received a sealed envelope that revealed their assignment" (p. 445)

Blinding of participants and personnel (performance bias)
All outcomes
Low riskParticipants not informed of the hypotheses of the study

Blinding of outcome assessment (detection bias)
All outcomes
Low riskInterviewers blinded to experimental condition

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNumber of participants at each follow-up time point not reported for each group

Selective reporting (reporting bias)Unclear riskOutcome data for self-efficacy not reported

Other biasLow riskNone

Manne 2011

MethodsStudy design: randomised controlled trial

Follow-up: eight weeks post-baseline


ParticipantsSeventy-one men and their partners were randomly assigned to an intervention group (n = 37) or a control group (n = 34). The mean age of the men was 60 years. Sixty-three (88.7%) were described as ‘white’ and eight (11.3%) as ‘non-white’. Eligibility criteria were those who were 18 years of age or older; diagnosed with localised prostate cancer in the year before the study; without a hearing impairment and able to speak English. All participants had an ECOG performance score of ‘0’ (fully active, able to carry on all predisease performance without restriction). Most (n = 60, 84.5%) were at stage II of prostate cancer, and 11 (15.5%) were at stage I. Forty-four (62%) had surgery; 20 (28.1%) had radiation therapy; three (4.2%) had hormone therapy and four (5.6%) had not begun treatment. Participants were recruited from two cancer centres in the Northeastern USA


InterventionsThe intimacy-enhancing psychological intervention (IET) used in this study consisted of five 90-minute sessions (within two months) with couples. Its content focused on improving couples’ ability to comfortably share their thoughts and feelings regarding cancer, promoting mutual understanding and support regarding their own and one another’s cancer experiences, facilitating constructive discussion of cancer concerns and enhancing and maintaining emotional intimacy (p. 1199-200). Techniques were derived from cognitive behavioural and behavioural marital therapy. Five therapists provided the intervention

Usual care participants could access a social worker routinely and, if required, were referred to a psychiatrist or a psychologist


OutcomesDistress (psychological)

24-Item Psychological Distress Scale of the Mental Health Inventory

Distress (cancer-specific)

15-Item Impact of Events Scale


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"A computerized system was used for allocation" (personal correspondence)

Allocation concealment (selection bias)Unclear risk"Concealed from staff before assignment but not afterwards" (personal correspondence); however, the actual method of concealment not stated

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot stated

Blinding of outcome assessment (detection bias)
All outcomes
Low riskParticipants sent questionnaires back to data collectors

Incomplete outcome data (attrition bias)
All outcomes
Low riskIntention-to-treat analysis carried out

Selective reporting (reporting bias)High riskOutcome data for psychological distress and cancer-specific distress not reported

Other biasLow riskNone

Mishel 2002

MethodsStudy design: randomised controlled trial

Follow-up: four and seven months post-baseline


ParticipantsTwo hundred fifty-two men diagnosed with localised prostate cancer and with two weeks post–catheter removal after surgery and within three weeks into radiation therapy were randomly assigned to two intervention groups or a control group. No data on the number of men allocated to any of the three groups were provided, although 13 (5%) dropped out before the final time point. Mean age of participants was 64. One hundred thirty-four (56%) were Caucasian, and 105 (44%) were African American. Most (61%) had stage T2 tumours, 27% had stage III and 8% had T1 tumours. Some participants (4%) did not know the stage of their cancer. Most had undergone surgery (79%), and 21% had received radiation therapy. Participants were recruited from nine treatment facilities in Central and Eastern North Carolina, USA


InterventionsThis study had two intervention groups and one control group. In one group, only the participant received the intervention (treatment direct group), and in the other, both the participant and a family member received the intervention (treatment-supplemented group). The intervention given to both groups was the same. It was an individually tailored, telephone-based psychoeducation intervention delivered during eight consecutive weeks (one hour per week). It consisted mainly of validating and reinforcing the views and behaviours of the participants, providing information, activating resources, teaching symptom management, structuring expectations and teaching problem solving and assertion techniques for communicating with healthcare providers. Both interventions were delivered by nurses

The usual care group received the same non-prostate cancer-specific printed material about health in general


OutcomesUncertainty

26-Item Version of Mishel Uncertainty in Illness Scale

Knowledge (cancer)

21-Item, investigator-developed Cancer Knowledge Scale

Distress

15-Item Symptom Distress Scale


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskStated that "men were blocked on ethnicity and randomly assigned to treatment or control groups", but randomisation method not given

Allocation concealment (selection bias)Unclear riskNot stated

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskMentioned that data collectors were not involved in delivery of the intervention (p. 1858), but no information provided on whether they were blinded to group allocation

Incomplete outcome data (attrition bias)
All outcomes
High riskNo information provided about the number of participants in each group at four and seven month follow-up time points

Selective reporting (reporting bias)Low riskAll outcomes reported

Other biasLow riskNone

Mishel 2009

MethodsStudy design: randomised controlled trial

Follow-up: four weeks and three months post-baseline


ParticipantsTwo hundred fifty-six men, newly diagnosed with cancer, were randomly assigned to one of three groups: men only (n = 93), men and a primary support person (n = 89) or control group (n = 74). No data were available on the number who completed in each group. The mean age of participants was 62.5 years (SD 7.4), and the ethnic composition was Caucasian 71.5% and African American 28.5%. Participants were recruited from six sites in North Carolina, USA. Eligibility criteria included men at stage T1a, T1b, T1c or T2a or with a Gleason score < 10; PSA levels < 120; no major cognitive impairment; ability to read and access to a telephone


InterventionsThe intervention dealt with communication strategies presented through a DVD, a booklet and four telephone calls to participants by a nurse trained in the intervention. The calls were delivered over seven to 10 days and consisted of helping participants to identify and formulate specific questions and to practice communication skills with the nurse on the telephone. The same intervention was delivered directly to the men only group and to the men and primary support person group

Control group participants received only a handout on staying healthy during treatment


OutcomesKnowledge (prostate cancer)

20-Item, investigator-developed Prostate Cancer Scale

Quality of life

Single item, in a visual analogue format, asking respondents to indicate, on a scale of one to 10, how positive they felt about their quality of life


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomisation method not described

Allocation concealment (selection bias)Unclear riskNot stated

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskData collection done over the phone (p. 350) but not known whether assessors were aware of group allocation

Incomplete outcome data (attrition bias)
All outcomes
High riskNumber of participants in each group at follow-up time points not given

Selective reporting (reporting bias)Low riskAll outcome data reported

Other biasLow riskNone

Northouse 2007

MethodsStudy design: randomised controlled trial

Follow-up: four, eight and 12 months post-baseline


ParticipantsTwo hundred sixty-three participant-spouse dyads were randomly assigned to a standard care group (n = 143) or a 'standard care plus a five-session family intervention' group (n = 129). Of the 235 who completed at four months, 84% were Caucasian, 14% African American and 2% Hispanic. The average age of male participants was 63 years (SD 9.78; range 42 to 90). Sixty-five per cent of men were in the newly diagnosed stage, 14% in the biochemical recurrent stage and 21% in the advanced stage of prostate cancer. Eligibility criteria were patients ≥ 30 years of age; a life expectancy ≥ 12 months and a spouse or live-in partner and residence within 75 miles of participating cancer centres. Those with a second primary cancer were excluded. Participants were recruited from three large cancer centres in the Midwest of the USA.


InterventionsThe supportive-educative intervention, called the FOCUS programme, comprised five core components: family involvement, optimistic attitude, coping effectiveness, uncertainty reduction and symptom management. Nurses were trained to deliver the intervention via three 90-minute home visits and two 30-minute telephone sessions spaced two weeks apart and delivered between baseline and four months

Participants in the control group received standard clinic care at their cancer centre. Although these centres offered some support groups, no specific psychosocial resources were provided for couples facing prostate cancer


OutcomesQuality of life (general healthrelated)

Medical Outcomes Study (MOS SF-12 version 2)

Quality of life (cancer-related)

Functional Assessment of Cancer Treatment (FACT-G version 4)

Quality of life (prostate cancerspecific)

Functional Assessment of Cancer Treatment (FACT-P)

Quality of life (symptom-related)

50-Item Expanded Prostate Cancer Index Composite (EPIC)

Uncertainty

28-Item Mishel Uncertainty in Illness Scale

Self-efficacy

17-Item Lewis Cancer Self-efficacy Scale

Distress (general symptom)

16-Item Symptom Scale of the Omega Screening Questionnaire (OSQ)


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"Used a random number list" (personal correspondence)

Allocation concealment (selection bias)High riskParticipants were told of group allocation as per IRB requirements (personal correspondence)

Blinding of participants and personnel (performance bias)
All outcomes
High riskAs above

Blinding of outcome assessment (detection bias)
All outcomes
Low riskData collection nurses, who were blinded to group assignment, collected the data

Incomplete outcome data (attrition bias)
All outcomes
Low riskRandom-effects regression models were used to analyse all available data rather than dropping participants with missing data (p. 2814)

Selective reporting (reporting bias)Low riskAll outcome data reported or available from the author

Other biasLow riskNone

Parker 2009

MethodsStudy design: randomised controlled trial

Follow-up: six weeks, six months and 12 months post-baseline


ParticipantsOne hundred fifty-nine men at the early stage of prostate cancer, undergoing radical prostatectomy, were randomly assigned to one of three groups: stress management (n = 53), supportive attention (n = 54) or standard care (n = 52). Their mean age was 60.5 years. The ethnic composition of participants was as follows: 78% (n = 124) white, 13% (n = 21) African American and 4.4% (n = 7) Hispanic/Latino. Almost three quarters (74.4%) of the men were at stage II prostate cancer; 12.8% were at stage I and 12.8% at stage III. Participants were recruited from three hospitals in Texas, USA


InterventionsTwo intervention groups and one control group were included

The stress management (SM) intervention consisted of two 60- to 90-minute and two short booster individual sessions with a clinical psychologist. The sessions were cognitive behavioural in nature with approximately 60% of the time focused on relaxation skills. Problem-solving strategies were discussed, and informational material and audiotapes were provided

The supportive attention (SA) intervention consisted of two 60- to 90-minute and two short booster sessions, provided before and after surgery. The same clinical psychologist (as in the SM group) provided empathy and used reflective listening skills. Participants had the opportunity to discuss their concerns with the psychologist

The SM and SA interventions were delivered approximately one to two weeks before surgery

The standard care group (control) received routine care and did not have meetings with a clinical psychologist


OutcomesQuality of life (general healthrelated)

Short Form-36 (SF-36)

Quality of life (symptom-related)

UCLA Prostate Cancer Index (PCI)


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskMinimisation used

Allocation concealment (selection bias)High risk"It was not a blinded trial" (personal communication)

Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants not stated. The same psychologist delivered both interventions

Blinding of outcome assessment (detection bias)
All outcomes
Low risk"A dedicated research assistant, who was blinded to group assignment, collected all measures" (p. 3170)

Incomplete outcome data (attrition bias)
All outcomes
High riskReasons for non-completion not reported

Selective reporting (reporting bias)Low riskAll data on relevant outcomes reported

Other biasHigh riskA high attrition rate reported (> 36%)

Penedo 2006

MethodsStudy design: randomised controlled trial

Follow-up: within two to three weeks post-intervention


ParticipantsTwo hundred thirty-five men who had undergone radical prostatectomy or radiation therapy for stage I or II prostate cancer were randomly assigned to a cognitive behavioural stress management intervention (n = 134) or a control group (n = 101). Participants were non-Hispanic white (40%), Hispanic (41%) and African American (18%), and the average age was 65.1 (SD 7.7; range 47 to 84) years. Eligibility criteria included patients over 45 years old, with no prior history of cancer, who had received treatment within the 18 months before study enrolment. A screening interview was used to assess reading level and absence of cognitive impairment. Participants were recruited from a number of sites in Florida, USA


InterventionsThe cognitive behavioural stress management (CBSM) intervention for prostate cancer was designed to provide participants with skills to manage daily stressors as well as prostate cancer–associated physical and emotional challenges, including sexual dysfunction, spousal or partner relations and engagement of the medical systems. The intervention provided individuals with effective coping skills and stress management techniques, as well as relevant information about prostate cancer, treatment and recovery. It comprised didactic instruction, discussion and relaxation. It was delivered to groups of four to eight participants for two hours once a week for 10 weeks

Control group participants met once for a four-hour seminar (in groups of four to eight) and received basic educational materials on the stress management techniques presented in the CBSM intervention


OutcomesQuality of life (cancer-related)

Functional Assessment of Cancer Therapy-General Module (FACT-G)


Notes"No study-related adverse events were reported in either condition" (p. 263)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskFlipping a coin

Allocation concealment (selection bias)Unclear riskNot stated

Blinding of participants and personnel (performance bias)
All outcomes
High riskStated that several participants were aware of group assignment, although this was not overtly discussed with them

Blinding of outcome assessment (detection bias)
All outcomes
Low riskAssessors and data entry staff blind to participant group assignment

Incomplete outcome data (attrition bias)
All outcomes
Low riskMissing data explained

Selective reporting (reporting bias)Low riskAll outcome data reported

Other biasLow riskNone

Penedo 2007

MethodsStudy design: randomised controlled trial

Follow-up: two to three weeks post-intervention


ParticipantsNinety-three monolingual Spanish-speaking men with prostate cancer were randomly assigned to a cognitive behavioural stress management intervention (n = 53) or a control group (n = 40). Of these, 71 completed the study at two to three weeks post-intervention. Thirty-two (45.1%) had undergone radical prostatectomy, and 39 (54.9%) had undergone radiotherapy for localised prostate cancer within 21 months before the study began. Their mean age was 63.5 (SD 7.6) years. The ethnic composition was Cuban/Cuban-American (62%), Colombian/Colombian-American (15%), other Central American countries (10%) and other South American countries (4%). Eight per cent did not specify their country of origin. Average years lived in the USA was 27 (SD 15.5). Participants were recruited in Florida, USA


InterventionsThe one-week, group-based cognitive behavioural stress management (CBSM) intervention was tailored for Spanish-speaking men in terms of their specific cultural and linguistic needs. Each session lasted two hours (90 minutes didactic and 30 minutes relaxation training). Topics included cognitive behavioural approaches to stress management (e.g. identification of distorted thoughts, rational thought replacement, effective coping, anger management, assertiveness training and social support development) and information specific to prostate cancer treatment and side effects. Relaxation training included deep breathing, progressive muscle relation and imagery

Control group participants were invited (in groups of four to six) to attend a half-day psychoeducational seminar consisting of a single four-hour session presenting a summary of the content of the CBSM programme. Both groups were co-facilitated by a clinical health psychology graduate student and a doctoral level licensed clinical psychologist, both of whom were fluent in Spanish and trained in the CBSM protocol


OutcomesQuality of life (cancer-related)

Functional Assessment of Cancer Therapy-General Module (FACT-G) Spanish version 4


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"Drawing numbers from a box" (p. 166)

Allocation concealment (selection bias)Unclear riskNot stated

Blinding of participants and personnel (performance bias)
All outcomes
High riskStated that several participants were aware of group assignment, although this was not overtly discussed with them

Blinding of outcome assessment (detection bias)
All outcomes
Low riskAssessors and data entry staff blind to group assignment

Incomplete outcome data (attrition bias)
All outcomes
Low riskMissing data accounted for

Selective reporting (reporting bias)Low riskAll outcome data reported

Other biasLow riskNone

Thornton 2004

MethodsStudy design: randomised controlled trial

Follow-up: three weeks, six months and one year post-baseline


ParticipantsOne hundred six men with prostate cancer (beginning before radical prostatectomy and proceeding across the first year of surgery) were randomly assigned to an intervention group (n = 53) or a control group (n = 53). Of these, 92 (87%) were Caucasian, five (4.7%) African American and six (6.4%) Latino. Their mean age was 61.2 years. Most (94%) had undergone a nerve-sparing radical prostatectomy for early (stage A or B, 82%) or locally extended prostate cancer (stage C, 17%). Twenty-six (24.5%) participants did not complete the study at the final time point. Participants were recruited from a cancer centre in California, USA


InterventionsThe intervention was a 45-minute, one-time psychological intervention aimed at enhancing communication with healthcare professionals and between the participant-partner dyad. It was also designed to help participants obtain relevant information. It was delivered by an MSc trained clinical or counselling psychologist or a clinical social worker

The control group received standard care and information primarily related to surgery (dealing with issues such as sexuality, pain control, incontinence, pelvic floor exercises, medication and support group information). Participants in the intervention group received standard care, as well as the 45-minute intervention session


OutcomesQuality of life (general healthrelated)

Short Form Health Survey (SF-36)

Quality of life (prostate cancerspecific)

Functional Assessment of Cancer Treatment-Prostate version (FACT-P)


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskMethod of randomisation not stated

Allocation concealment (selection bias)Unclear riskNot stated

Blinding of participants and personnel (performance bias)
All outcomes
High riskPatients were informed of their group assignment as per instruction from the Institutional Review Board (p. 19)

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot stated

Incomplete outcome data (attrition bias)
All outcomes
High riskMissing data on participants who did not complete the study not explained

Selective reporting (reporting bias)High riskData collected at six months not reported. Outcome data for the control group at the three follow-up time points not reported

Other biasLow riskNone

Weber 2007

MethodsStudy design: randomised controlled trial

Follow-up: four weeks and eight weeks post-intervention


ParticipantsEighty-one men, who had undergone radical prostatectomy previously, were randomly assigned to an intervention group or a control group. Complete data were available on 72 men (37 in the intervention group and 35 in the control group). Of these, 60 (83.3%) were white, eight (11.1%) African American, two (4.2%) Hispanic and one Asian. Their mean age was 60 years (SD 7), with a range of 47 to 74 years. Inclusion criteria were men with localised prostate cancer; 45 years or older; with no psychiatric disorders and English speaking. Participants were recruited from the urology clinics at two tertiary care medical centres in the Southeastern USA


InterventionsIn addition to usual care from their urologist, participants received an intervention that consisted of pairing the participant with a former patient (to form a dyad) who had had a radical prostatectomy at least three years before the start of the study and had experienced similar treatment side effects as those experienced by participants. The dyads met eight times during an eight-week period, when the support partner was "able to vicariously relate successful coping and recovery strategies after prostatectomy" (p. 157)

Men in the control group received usual health care provided by their urologist


OutcomesQuality of life (general healthrelated)

36-Item Rand Medical Outcomes Study Short Form (SF-36)

Quality of life (symptom-related)

20-Item UCLA Prostate Cancer Index

Depressive symptoms

15-Item Geriatric Depression Scale

Self-efficacy adjustment

38-Item Stanford Inventory of the Cancer Patient Adjustment (SIPCA)


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskTossing a coin (personal correspondence)

Allocation concealment (selection bias)Low riskEnvelopes used (personal correspondence)

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot mentioned

Blinding of outcome assessment (detection bias)
All outcomes
Low riskData collectors blinded to group allocation (personal correspondence)

Incomplete outcome data (attrition bias)
All outcomes
Low riskMissing data reported

Selective reporting (reporting bias)Unclear riskOutcome data for one of the follow-up time points (four months) not reported

Other biasUnclear riskNone

Zhang 2006

MethodsStudy design: randomised controlled trial

Follow-up: three months post-baseline


ParticipantsTwenty-nine men with prostate cancer were randomly assigned to an intervention group (n = 14) or a control group (n = 15). Inclusion criteria were patients at stages I to III prostate cancer; had received surgical treatment longer than six months before the start of the study and were experiencing urinary incontinence during the week before the start of the study. The mean age of the 27 men who completed the study was 61.5 years, and the overall ethnic composition of the sample was 71.9% white and 28.1% African American. The control group had fewer African American participants (13.3%) than the support group (42.9%). Participants were recruited from two major hospitals in Ohio, USA


InterventionsBoth intervention and control group participants carried out pelvic floor exercises and received biofeedback via a sensor inserted in the participant’s rectum and connected to a computer monitor

The intervention group additionally received social support at six biweekly meetings held over a period of three months. Each meeting (four to five participants), facilitated by a ‘licensed’ health psychologist, lasted 90 to 120 minutes. During the meeting, the psychologist provided information about anatomy and physiology of urinary incontinence and moderated group discussions regarding experiences and problems with pelvic floor muscle exercises, personal struggles with functional difficulties in daily life, family communication about sexual dysfunction and other psychosocial issues such as stigma, loneliness and social relations

The control group carried out the pelvic floor exercises with biofeedback only


OutcomesQuality of life (physical function)

10-Item Medical Outcomes Study Physical Functioning Measure (MOS-PF)

Symptom distress

McCorkle and Young Symptom Distress Scale


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskA table of random numbers was used (personal communication)

Allocation concealment (selection bias)High riskNo concealment method used (personal communication)

Blinding of participants and personnel (performance bias)
All outcomes
High riskMentions that one participant dropped out because of dissatisfaction with assignment to the control group. Blinding of personnel not stated

Blinding of outcome assessment (detection bias)
All outcomes
Low riskData collectors blind to group assignment (personal communication)

Incomplete outcome data (attrition bias)
All outcomes
Low riskDetails of missing data given

Selective reporting (reporting bias)High riskTwo prespecified outcomes (symptom distress and general emotional disturbance) not reported in the paper and not available from the author (personal correspondence)

Other biasHigh riskSignificantly more African Americans in the intervention group (42.9%) than in the control group (13.3%)

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Badger 2011Two interventions and no control (usual care)

Beard 2011Does not meet inclusion criteria for psychosocial intervention

Burgio 2006Does not meet inclusion criteria for psychosocial intervention

Canada 2005No control group. The study compared the effects of the intervention between two groups: men alone and men attending with their partners

Davison 2007Did not measure outcomes relevant to this review

Downe-Wamboldt 2007Includes prostate cancer patients, but data not analysed separately

Goode 2011Does not meet inclusion criteria for psychosocial intervention

Green 2002Does not meet inclusion criteria for psychosocial intervention

Gyomber 2010Does not meet inclusion criteria for psychosocial intervention

Hack 2007Does not meet inclusion criteria for psychosocial intervention

Hellbom 1998Includes prostate cancer patients, but data not analysed separately

Ibfelt 2011Includes prostate cancer patients, but data not analysed separately

Johansson 2001Includes prostate cancer patients, but data not analysed separately

Johansson 2008Includes prostate cancer patients, but data not analysed separately

Johnson 1996Does not meet inclusion criteria for psychosocial intervention

Jones 2006Includes prostate cancer patients, but data not analysed separately

Kim 2002Does not meet inclusion criteria for psychosocial intervention

Kornblith 2006Includes prostate cancer patients, but data not analysed separately

Lee 2009Does not meet criteria for psychosocial intervention

Livingston 2010Includes prostate cancer patients, but data not analysed separately

Mohide 1996Does not meet inclusion criteria for psychosocial intervention

Morey 2009Includes prostate cancer patients, but data not analysed separately

Ramachandra 2009Includes prostate cancer patients, but data not analysed separately

Rottmann 2011Includes prostate cancer patients, but data not analysed separately

Scura 2004Very small sample (n = 17). Outcome data for control and intervention groups not reported separately

Siddons 2013Primary outcome was psychosexual adjustment, and extractable data (for meta-analysis; e.g. standard deviations) not reported

Simeit 2004Includes prostate cancer patients, but data not analysed separately

Stiegelis 2004Includes prostate cancer patients, but data not analysed separately

Templeton 2004Does not meet inclusion criteria for psychosocial intervention

Zakowski 2004Includes prostate cancer patients, but data not analysed separately

 
Comparison 1. Psychosocial intervention versus usual care

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 General health–related quality of life: physical component at end of intervention61414Std. Mean Difference (IV, Random, 95% CI)0.12 [0.01, 0.22]

    1.1 Group-based intervention
2362Std. Mean Difference (IV, Random, 95% CI)0.24 [0.02, 0.47]

    1.2 Individual-based intervention
41052Std. Mean Difference (IV, Random, 95% CI)0.11 [-0.06, 0.28]

 2 General health–related quality of life: physical component at four to six months51357Std. Mean Difference (IV, Random, 95% CI)0.02 [-0.09, 0.13]

    2.1 Group-based intervention
2363Std. Mean Difference (IV, Random, 95% CI)0.17 [-0.05, 0.40]

    2.2 Individual-based intervention
3994Std. Mean Difference (IV, Random, 95% CI)-0.03 [-0.16, 0.10]

 3 General health–related quality of life: physical component at eight to 12 months41215Std. Mean Difference (IV, Random, 95% CI)0.14 [-0.03, 0.32]

    3.1 Group-based intervention
1250Std. Mean Difference (IV, Random, 95% CI)0.15 [-0.12, 0.42]

    3.2 Individual-based intervention
3965Std. Mean Difference (IV, Random, 95% CI)0.19 [-0.07, 0.46]

 4 General health–related quality of lIfe: mental component at end of intervention61416Std. Mean Difference (IV, Random, 95% CI)-0.04 [-0.15, 0.06]

    4.1 Group-based intervention
2362Std. Mean Difference (IV, Random, 95% CI)-0.02 [-0.24, 0.20]

    4.2 Individual-based intervention
41054Std. Mean Difference (IV, Random, 95% CI)-0.05 [-0.17, 0.07]

 5 General health–related quality of life: mental component at four to six months51357Std. Mean Difference (IV, Random, 95% CI)-0.08 [-0.19, 0.03]

    5.1 Group-based intervention
2363Std. Mean Difference (IV, Random, 95% CI)-0.01 [-0.23, 0.21]

    5.2 Individual-based intervention
3994Std. Mean Difference (IV, Random, 95% CI)-0.11 [-0.23, 0.02]

 6 General health–related quality of life: mental component at eight to 12 months41215Std. Mean Difference (IV, Random, 95% CI)-0.04 [-0.15, 0.08]

    6.1 Group-based intervention
1250Std. Mean Difference (IV, Random, 95% CI)0.01 [-0.25, 0.28]

    6.2 Individual-based intervention
3965Std. Mean Difference (IV, Random, 95% CI)-0.05 [-0.17, 0.08]

 7 Cancer-related quality of life (FACT-G) at end of intervention3497Std. Mean Difference (IV, Random, 95% CI)0.21 [0.04, 0.39]

    7.1 Group-based intervention
2262Std. Mean Difference (IV, Random, 95% CI)0.30 [-0.04, 0.64]

    7.2 Individual-based intervention
1235Std. Mean Difference (IV, Random, 95% CI)0.16 [-0.09, 0.42]

 8 Cancer-related quality of life (FACT-G) at eight and 12 months1Std. Mean Difference (IV, Random, 95% CI)Subtotals only

    8.1 Eight months post-intervention
1228Std. Mean Difference (IV, Random, 95% CI)0.01 [-0.25, 0.27]

    8.2 12 months post-intervention
1218Std. Mean Difference (IV, Random, 95% CI)0.03 [-0.24, 0.29]

 9 Prostate cancer–specific quality of life (FACT-P)1Std. Mean Difference (IV, Random, 95% CI)Subtotals only

    9.1 End of intervention
1219Std. Mean Difference (IV, Random, 95% CI)0.13 [-0.14, 0.39]

    9.2 Eight months post-intervention
1219Std. Mean Difference (IV, Random, 95% CI)-0.07 [-0.34, 0.19]

    9.3 12 months post-intervention
1219Std. Mean Difference (IV, Random, 95% CI)0.14 [-0.13, 0.40]

 10 Symptom-related quality of life (EPIC) at end of intervention3Std. Mean Difference (IV, Random, 95% CI)Subtotals only

    10.1 Urinary domain
3946Std. Mean Difference (IV, Random, 95% CI)0.18 [-0.16, 0.52]

    10.2 Bowel domain
3946Std. Mean Difference (IV, Random, 95% CI)-0.02 [-0.15, 0.10]

    10.3 Sexual domain
3946Std. Mean Difference (IV, Random, 95% CI)0.03 [-0.10, 0.16]

    10.4 Hormonal domain
2265Std. Mean Difference (IV, Random, 95% CI)0.17 [-0.36, 0.70]

 11 Symptom-related quality of life (EPIC) at six to eight months post-intervention2Std. Mean Difference (IV, Random, 95% CI)Subtotals only

    11.1 Urinary domain
2887Std. Mean Difference (IV, Random, 95% CI)-0.02 [-0.19, 0.14]

    11.2 Bowel domain
2887Std. Mean Difference (IV, Random, 95% CI)-0.06 [-0.26, 0.15]

    11.3 Sexual domain
2887Std. Mean Difference (IV, Random, 95% CI)0.09 [-0.04, 0.22]

 12 Symptom-related quality of life (EPIC) at 12 months post-intervention2Std. Mean Difference (IV, Random, 95% CI)Subtotals only

    12.1 Urinary domain
2864Std. Mean Difference (IV, Random, 95% CI)-0.07 [-0.21, 0.06]

    12.2 Bowel domain
2864Std. Mean Difference (IV, Random, 95% CI)0.00 [-0.14, 0.14]

    12.3 Sexual domain
2864Std. Mean Difference (IV, Random, 95% CI)0.03 [-0.11, 0.16]

 13 Symptom-related quality of life (UCLA-PCI) at end of intervention3Std. Mean Difference (IV, Random, 95% CI)Subtotals only

    13.1 Urinary function
3428Std. Mean Difference (IV, Random, 95% CI)0.14 [-0.06, 0.34]

    13.2 Urinary bother
3428Std. Mean Difference (IV, Random, 95% CI)0.01 [-0.19, 0.21]

    13.3 Sexual function
3428Std. Mean Difference (IV, Random, 95% CI)0.00 [-0.20, 0.20]

    13.4 Sexual bother
3428Std. Mean Difference (IV, Random, 95% CI)0.17 [-0.03, 0.37]

    13.5 Bowel function
3430Std. Mean Difference (IV, Random, 95% CI)-0.07 [-0.27, 0.13]

    13.6 Bowel bother
3428Std. Mean Difference (IV, Random, 95% CI)0.02 [-0.18, 0.22]

 14 Symptom-related quality of life (UCLA-PCI) at six months2Std. Mean Difference (IV, Random, 95% CI)Subtotals only

    14.1 Urinary function
2357Std. Mean Difference (IV, Random, 95% CI)-0.01 [-0.24, 0.21]

    14.2 Urinary bother
2357Std. Mean Difference (IV, Random, 95% CI)-0.01 [-0.23, 0.21]

    14.3 Sexual function
2357Std. Mean Difference (IV, Random, 95% CI)0.11 [-0.11, 0.33]

    14.4 Sexual bother
2357Std. Mean Difference (IV, Random, 95% CI)0.20 [-0.02, 0.43]

    14.5 Bowel function
2357Std. Mean Difference (IV, Random, 95% CI)-0.20 [-0.42, 0.02]

    14.6 Bowel bother
2357Std. Mean Difference (IV, Random, 95% CI)-0.04 [-0.26, 0.18]

 15 Symptom-related quality of life (UCLA-PCI) at 12 months2Std. Mean Difference (IV, Random, 95% CI)Subtotals only

    15.1 Urinary function
2351Std. Mean Difference (IV, Random, 95% CI)0.11 [-0.12, 0.33]

    15.2 Urinary bother
2351Std. Mean Difference (IV, Random, 95% CI)-0.05 [-0.27, 0.18]

    15.3 Sexual function
2351Std. Mean Difference (IV, Random, 95% CI)0.10 [-0.13, 0.32]

    15.4 Sexual bother
2351Std. Mean Difference (IV, Random, 95% CI)0.21 [-0.08, 0.49]

    15.5 Bowel function
2351Std. Mean Difference (IV, Random, 95% CI)-0.05 [-0.28, 0.17]

    15.6 Bowel bother
2351Std. Mean Difference (IV, Random, 95% CI)0.00 [-0.22, 0.22]

 16 Self-efficacy at end of intervention3337Std. Mean Difference (IV, Fixed, 95% CI)0.16 [-0.05, 0.38]

 17 Self-efficacy at eight and 12 months1Std. Mean Difference (IV, Random, 95% CI)Subtotals only

    17.1 Self-efficacy at eight months
1228Std. Mean Difference (IV, Random, 95% CI)-0.05 [-0.31, 0.21]

    17.2 Self-efficacy at 12 months
1218Std. Mean Difference (IV, Random, 95% CI)-0.07 [-0.34, 0.20]

 18 Prostate cancer knowledge at end of intervention2506Std. Mean Difference (IV, Random, 95% CI)0.51 [0.32, 0.71]

    18.1 Group-based intervention
1250Std. Mean Difference (IV, Random, 95% CI)0.68 [0.41, 0.95]

    18.2 Individual-based intervention
1256Std. Mean Difference (IV, Random, 95% CI)0.35 [0.08, 0.62]

 19 Prostate cancer knowledge at three months post-intervention1256Std. Mean Difference (IV, Random, 95% CI)0.31 [0.04, 0.58]

    19.1 Individual-based intervention
1256Std. Mean Difference (IV, Random, 95% CI)0.31 [0.04, 0.58]

 20 Uncertainty at end of intervention2916Std. Mean Difference (IV, Random, 95% CI)-0.05 [-0.35, 0.26]

 21 Uncertainty at six to eight months post-intervention2887Std. Mean Difference (IV, Random, 95% CI)0.04 [-0.09, 0.17]

 22 Uncertainty at 12 months post-intervention2864Std. Mean Difference (IV, Random, 95% CI)0.07 [-0.06, 0.21]

 23 Distress2Std. Mean Difference (IV, Random, 95% CI)Subtotals only

    23.1 Distress at end of intervention
2916Std. Mean Difference (IV, Random, 95% CI)0.02 [-0.11, 0.15]

    23.2 Distress at six to eight months post-intervention
2887Std. Mean Difference (IV, Random, 95% CI)0.06 [-0.07, 0.19]

    23.3 Distress at 12 months post-intervention
2864Std. Mean Difference (IV, Random, 95% CI)0.02 [-0.11, 0.15]

 24 Depression at end of intervention3434Std. Mean Difference (IV, Random, 95% CI)-0.18 [-0.51, 0.15]

    24.1 Group-based intervention
2362Std. Mean Difference (IV, Random, 95% CI)-0.06 [-0.38, 0.25]

    24.2 Individual-based intervention
172Std. Mean Difference (IV, Random, 95% CI)-0.59 [-1.06, -0.11]

 25 Depression at six months post-intervention2364Std. Mean Difference (IV, Random, 95% CI)-0.17 [-0.44, 0.09]

    25.1 Group-based intervention
2364Std. Mean Difference (IV, Random, 95% CI)-0.17 [-0.44, 0.09]

 26 Depression at 12 months post-intervention1250Std. Mean Difference (IV, Random, 95% CI)-0.02 [-0.29, 0.24]

    26.1 Group-based intervention
1250Std. Mean Difference (IV, Random, 95% CI)-0.02 [-0.29, 0.24]

 
Summary of findings for the main comparison. Psychosocial interventions compared with usual care for men with prostate cancer

Psychosocial interventions compared with usual care for men with prostate cancer

Patient or population: patients with prostate cancer
Settings: hospital and community
Intervention: psychosocial interventions
Comparison: usual care

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

Usual carePsychosocial interventions

General healthrelated quality of life: physical component at end of interventionSee commentMean general health–related quality of life: physical component at end of intervention in the intervention groups was
0.12 standard deviations higher
(0.01 to 0.22 higher)
-1414
(six studies)
⊕⊕⊝⊝
low1,2,3,4
SMD 0.12 (95% CI 0.01 to 0.22)

General healthrelated quality of life: mental component at end of interventionSee commentMean general health–related quality of life: mental component at end of intervention in the intervention groups was
0.04 standard deviations lower
(0.15 lower to 0.06 higher)
-1416
(six studies)
⊕⊕⊕⊝
moderate1,2,3
SMD -0.04 (95% CI -0.15 to 0.06)

Self-efficacy at end of interventionSee commentMean self-efficacy at end of intervention in the intervention groups was
0.16 standard deviations higher
(0.05 lower to 0.38 higher)
-337
(three studies)
⊕⊝⊝⊝
very low1,2,4,5
SMD 0.16 (95% CI -0.05 to 0.38)

Prostate cancer knowledge at end of interventionSee commentMean prostate cancer knowledge at end of intervention in the intervention groups was
0.51 standard deviations higher
(0.32 to 0.71 higher)
-506
(two studies)
⊕⊝⊝⊝
very low6,7,8,9
SMD 0.51 (95% CI 0.32 to 0.71)

Uncertainty at end of interventionSee commentMean uncertainty at end of intervention in the intervention groups was
0.05 standard deviations lower
(0.35 lower to 0.26 higher)
-916
(two studies)
⊕⊝⊝⊝
very low1,2,5,10
SMD -0.05 (95% CI -0.35 to 0.26)

Distress at end of interventionSee commentMean distress at end of intervention in the intervention groups was
0.02 standard deviations higher
(0.11 lower to 0.15 higher)
-916
(two studies)
⊕⊝⊝⊝
very low1,2,10
SMD 0.02 (95% CI -0.11 to 0.15)

Depression at end of interventionSee commentMean depression at end of intervention in the intervention groups was
0.18 standard deviations lower
(0.51 lower to 0.15 higher)
-434
(three studies)
⊕⊝⊝⊝
very low3,5,6,7,10
SMD -0.18 (95% CI -0.51 to 0.15)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; SMD: Standardised mean difference.

GRADE Working Group grades of evidence.
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1Lack of blinding.
2Lack of allocation concealment.
3Selective reporting.
495% CI crosses the minimal important difference.
5I2 > 50%.
6Unclear blinding.
7Unclear allocation concealment.
8Significant loss to follow-up.
9Instruments used were not validated.
10Findings consistent with both clinically significant benefit and harm.