Prostate cancer is the most common cancer in men and the second most common cause of cancer death among men in the United Kingdom (Cancer Research UK 2008). More than 670,000 men are diagnosed with prostate cancer each year (Cancer Research UK 2009). In the US, one in six (16.7%) of all men will develop prostate cancer during his lifetime (American Cancer Society 2009). There is a large body of evidence that shows that the diagnosis of prostate cancer brings with it significant psychosocial problems, including fear, anxiety and distress, which can lead to depression (e.g. Carlson 2004; Lintz 2003; Namiki 2007). A patient's family can be affected as well (Balderson 2003), and lead to a reduced quality of life for himself (Northouse 2007). Yet despite this evidence, not much is known about psychosocial interventions to prevent and help men cope with the stress that they commonly experience. There is a growing challenge to devise and test interventions which can help people with the sequelae (effects) of the disease, its treatment, and the psychosocial impact on their lives.
For many cancers there has been a proliferation of studies that examine psychosocial interventions to help people cope with the effects of their disease; there are very few studies for prostate cancer (Zabora 2001). The findings of studies from cancer patients with other malignancies may have limited applications for men with prostate cancer (Balderson 2003). Yet this situation is changing.
In a review of literature of psychosocial interventions between 1970 and 2004, Weber (Weber 2005) found 9 RCTs (randomised, controlled trials). It is likely that an updated systematic search will reveal more.
A brief review of psychosocial interventions in men with prostate cancer shows a range of outcome measures and instruments for data collection. The main outcome measures were knowledge, self-efficacy (the belief that an individual has control over events that affect his or her life), uncertainty, distress, depression, and quality of life (both general and disease-specific).
A search of the Cochrane Central Register of Controlled Trials (CENTRAL), PUBMED (1950 to June, 2010), MEDLINE (1966 to date), EMBASE (1980 to June 2010), CINAHL (1982 to June 2010) and PsyINFO (1806 to June 2010), did not reveal any systematic reviews of studies or protocols on the effectiveness of psychosocial interventions for men with prostate cancer.
This review is timely because the number of men living with prostate cancer continues to grow.
Description of the condition
All men medically diagnosed with prostate cancer and at any stage of the disease.
Description of the intervention
There are a variety of psychosocial interventions, including psycho-educational, cognitive behaviour therapy (CBT) (group or individual), group supportive therapy, and individual supportive therapy (Newell 2002). The term "psychosocial intervention" has also been used to describe interventions designed to provide information, physical exercise, relaxation, or art therapy. Interventions have been delivered to groups of patients or their partners, or both, by telephone, by sending information by mail, or by a combination of these approaches.
There has been a proliferation of research examining psychosocial interventions to help people cope with the effects of cancer from initial biopsy, diagnosis, treatment, palliation, and death (Zabora 2001). Systematic investigation of the effectiveness of psychosocial interventions since the 1970s have shown a benefit to cancer patients with respect to quality of life, coping, emotional distress, and problem solving (Weis 2003).
There have been a small number of studies of psychosocial interventions for prostate-cancer patients (Weber 2005). The interventions in these studies involved a variety of approaches. The most common was educational/informational, in the form of lectures, pamphlets or audiotape (Davison 1997; Wilt 2001; Kim 2002; Lepore 2003; Manne 2004; Templeton 2004; Giesler 2005). Other approaches included expression of feeling and experience through writing (Rosenberg 2002), problem-solving strategies (Mishel 2003), physical training alone or with information (Berglund 2007), and supportive/educative intervention (Northouse 2007). Some used a combination of approaches.
The findings showed a mixed picture of benefits and "no difference" between experimental and control groups. The most beneficial aspect was knowledge gain (Wilt 2001; Lepore 2003; Templeton 2004). Davison (Davison 1997) reported that patients took a more active role in decision making post-intervention (Davison 1997), but "expressive disclosure" had no effect on behavioural, medical, and immunological health outcomes (Rosenberg 2002). In a study by Kim (Kim 2002), the intervention group experienced significantly fewer problems with sleep as a result of receiving audio taped information. There was also a reduction in depression and an increase in self-efficacy (Weber 2005) and less worry (Giesler 2005). Berglund's (Berglund 2007) study, however, did not show a reduction in depression and anxiety as a result of their psychosocial rehabilitation intervention.
The findings related to quality of life were also equivocal. Studies by Templeton (Templeton 2004) and Geissler (Giesler 2005) show an increase in quality of life while those by Lepore (Lepore 2003), Berglund (Berglund 2007) did not.
Caution should be exercised when generalising from these studies as they used a variety of interventions and strategies both in terms of content, delivery, duration, outcome measures, sample size and composition. To date there is no systematic review of the effectiveness of psychosocial interventions for people with prostate cancer.
How the intervention might work
Most psychosocial interventions are based on theoretical frameworks which emphasize the importance of self management and positive coping strategies to maintain or enhance the person’s self esteem and competence to deal with the effects of illness. According to Von Korff (Von Korff 1997), most of them are based on four principles: illness management skills are learnt; motivation, self-efficacy and self confidence are crucial for self-management; and the social environment, in particular the family and social network can support or impede health care; and monitoring and responding to changes in disease state, symptoms, emotions and functioning improved adaptation to illness (Von Korff 1997).
Two of the most common theories which underpin self-management programmes are self-efficacy (Bandura 1997) and stress and coping (Lazarus 1984). Self-efficacy is the belief that an individual has control over events that affect his or her life. When a person is diagnosed with cancer he or she can feel "stunned" and "helpless" and may feel a loss of control over their lives (McCaughan 2007); this can lead to depression. A self-management programme that helps them to believe in themselves and to regain their control, can reverse the downward trend toward depression, and help them in their adjustment or resilience to adversity (Weber 2007).
The Transactional Model of Stress and Coping (Lazarus 1984) is a framework for evaluating the processes of coping with stressful events. When people are faced with a threat, they appraise the threat in terms of how challenging or controllable it is (this is termed the primary appraisal). They also appraise their own and external resources at their disposal to face the threat (secondary appraisal). How they eventually cope depends on these appraisals. If the disease is seen as overwhelming and their own and external resources inadequate, they may feel incapable of coping.
Why it is important to do this review
There is a need of evidence for practitioners to draw upon when dealing with psychosocial problems of this population. Organisations such as the National Institute of Clinical Excellence need evidence on which to base their guidelines (Wilt 2008).
A systematic review of the effectiveness of these interventions will inform us of the nature and quality of the evidence so far. Equally important is the need to review the quality of these studies, the types of interventions, the outcome measures, and the tools or instruments used to collect and analyse data. Recommendations for future research will be made to help researchers to address limitations of previous studies. This may lead to a better use of research funding and better quality evidence.
To evaluate the effectiveness of psychosocial interventions for men with prostate cancer, at all stages of the disease, and in particular to increase knowledge, self-efficacy, and quality of life, and to reduce uncertainty, distress and depression.
Knowledge, distress, uncertainty, depression, self-efficacy, and quality of life will be measured regardless of the variety of tools used in these studies. There are a number of standardised tools for each of these outcomes. There is a high likelihood that different researchers will use different tools to measure the same concept.
Criteria for considering studies for this review
Types of studies
All randomised controlled trials comparing one or more psychosocial interventions with a control group, and with or without blinding.
Types of participants
These will include all men diagnosed with prostate cancer (at all stages of the disease). Sub-group analyses will be carried out to evaluate effects on men at different stages of the disease. Studies will be included if it is possible to extract data on prostate cancer patients (if these studies include other cancer patients' groups). Studies of couples will be included if data for men can be extracted.
Types of interventions
Psychosocial interventions explicitly using one or a combination of the following approaches.
- Cognitive behaviour therapy (CBT)
Individual or group interventions, whether delivered via telephone, at home or during clinic visits (or a combination of these) by lay or trained personnel (or a combination of both) will be included. Interventions based solely on distribution of leaflets or other informational material (without an input from trained or lay personnel) will be excluded.
Types of outcome measures
The main outcome measures are knowledge, self-efficacy, uncertainty, distress, depression, and quality of life.
These outcome measures will be assessed using the following validated and established tools.
- Distress - Symptom Distress Scale
- Uncertainty - Adult Uncertainty in Illness Scale; The MUIS-S Mishel Uncertainty in Illness Scale
- Depression - Beck Depression Inventory, Hospital Anxiety and Depression Scale
- Self-efficacy - Rosenberg Self-Esteem Scale
- Quality of Life - European Organisation for Research and Treatment of Cancer (EORTC) or Functional Assessment of Cancer Therapy Scales (FACT), SF-36, GHQ-12
Search methods for identification of studies
Relevant databases will include Medline (1966 to June 2010), CancerLit (1983 to June 2010) and CINAHL (1982 to June 2010).
The Cochrane Library, including the Cochrane Prostate Diseases and Urologic Cancers Group registry, will be searched. Initial searches will include all studies on psychosocial interventions for patients with prostate cancer, and identified studies will then be screened to reveal only those that meet the inclusion criteria.
Search terms will include MeSH headings 'prostate neoplasms', 'prostate cancer', 'intervention', 'counselling', 'psychotherapy', 'cognitive behaviour therapy', 'education', 'information'.
No language restrictions will be applied. Studies published in languages other than English will be translated.
Searching other resources
Authors of identified trials will be contacted for additional published or unpublished trials carried out by themselves or by others. The reference lists of published trials will be also searched. The World Wide Web will be searched for reports and other literature referring to psychosocial interventions for men with prostate cancer.
Data collection and analysis
Titles and abstracts will be reviewed by two reviewers independently (KP and EM). The inclusion and exclusion criteria will be applied at this stage. Disagreements will be resolved by discussion between the pair of reviewers and, if necessary, with the help of a third reviewer (JN). The full article will be retrieved in cases where information contained in the abstract is not sufficient for a decision about selection to be made.
Selection of studies
A form will be developed for this purpose, based on recommended checklists in the literature for the appraisal of RCTs and after discussion with the review team. It is expected the form will comprise the following items: aims/objectives or hypotheses; study design; sample (including age and ethnicity) and sampling method; attrition; intervention (including types and duration, primary and secondary outcomes (including self-esteem, quality of lie, uncertainty, distress and depression); measurement tools; statistical tests; results and follow up.
Data extraction and management
Two assessors (KP and EM) will independently assess the quality of the selected RCTs using the above checklist. Disagreements will be resolved with the help of the third author (JN).
Assessment of risk of bias in included studies
Two reviewers (KP and EM) will independently use the Cochrane Collaboration tool "Risk of bias" Assessment tool (Higgins 2008) to assess risk of bias. Unresolved issues between the pair of reviewers will be referred to the third reviewer (JN). Studies at high risk of bias (Category C) will not be excluded from the review. Pooled outcomes and methodological study quality and bias will also be assessed by the GRADE criteria (GRADE 2004).
Measures of treatment effect
For dichotomous outcomes, the risk ratio (RR) with 95% CI will be used to measure treatment effect. Continuous outcomes will be analysed if the mean and standard deviation of endpoints (or mean changes) are presented in the reports.
The meta-analysis will be carried out in cases where there are 3 or more homogeneous outcomes (Egger 1997). Sub-group analyses will be performed to assess the effectiveness of different interventions and different stages of the condition (prostate cancer). The same will be performed for different scales, sub-scales or scores. For meta-analysis of continuous outcomes, weighted mean differences between groups will be estimated.
Unit of analysis issues
In cases of cluster-randomised and cross-over trials, the method of combining groups as recommended in the Cochrane Handbook (Higgins 2008) will be followed.
Dealing with missing data
Information about missing data will be extracted by two reviewers (KP and EM). The level of attrition and the different terms used (such as withdrawal, dropouts, deceased, etc.) to describe missing data on standard deviations will be analysed. A complete case analysis and an intention-to-treat analysis will be carried in studies with missing data. The limitations of such approaches will be noted in the review. "Intention to treat" data will be analysed.
Assessment of heterogeneity
The different types of heterogeneity (clinical, methodological and statistical) will be reported. The extent and proportion of heterogeneity will be assessed by the I
Assessment of reporting biases
Funnel plots and the Egger test (Egger 1997) will be used to assess reporting bias. Where the funnel plot shows asymmetry, possible explanations will be explored. Potential publication bias will be indicated if the Egger test shows a Y-intercept deviation from zero. We will also, to minimise publication bias, conduct multiple searches of electronic databases, contact authors, handsearch relevant published papers, clinical practice guidelines, and other systematic reviews.
Analysis of data using the Mantel-Haenszel random-effects model will be carried out by the principal reviewer (KP). The decision to exclude, or stratify, studies due to heterogeneity will be taken by two reviewers (KP and EM), and moderated by a third reviewer (JN), if required. We will assess for effect size inconsistency. For categorical effect measures we will use RR with 95% CI.
Subgroup analysis and investigation of heterogeneity
Statistical heterogeneity as well as sub-group analysis will be carried out. Variables for sub-group analysis will include types of intervention (e.g. with or without face-to-face contact between therapists and participants), sample size, ethnicity and age (under 65 versus 65 or older) of participants.
If there are sufficient trials, a sensitivity analysis will be performed to assess risk of bias and the impact of missing data on continuous and dichotomous outcomes. These will be carried out by one reviewer (KP) and moderated by a second reviewer (EM). The I
Last assessed as up-to-date: 25 January 2010.
Contributions of authors
The first two authors (KP and EM) will search, appraise, analyse data from the selected studies and write the review. The third and fourth authors (JN and SM) will help resolve disagreements and advise at every stage of the review.
Declarations of interest
Sources of support
- No sources of support supplied
- Research and Development Office (Northern Ireland), UK.Funding