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Keywords:

  • prostate cancer;
  • active surveillance;
  • decision-making;
  • information preferences;
  • psychological distress

Abstract

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. ACKNOWLEDGEMENTS
  8. CONFLICT OF INTEREST
  9. REFERENCES

Study Type – Decision analysis (lacking sensitivity analysis)

Level of Evidence 4

What’s known on the subject? and What does the study add?

Active surveillance is a management strategy that offers patients the hope of avoiding the side effects associated with unnecessary treatment. This study identifies the resources required by men who choose to be on active surveillance to support them in their treatment decision.

OBJECTIVES

  • • 
    To examine the decision-making processes of men on active surveillance (AS).
  • • 
    To identify the resources that men want to access to make, support and sustain them while on AS.

PATIENTS AND METHODS

  • • 
    Three-part survey developed for this study based on a qualitative study of 25 men on AS.
  • • 
    Survey items explored: role men assumed with their physician in treatment decision-making, factors influencing decision to go on AS, and resources required while on AS.
  • • 
    Surveys mailed out to cross-sectional sample of men on AS for less than 10 years.

RESULTS

  • • 
    27% of the 73 men reported assuming an active role in treatment decision-making with their urologist, 41% a shared role and 32% a passive role.
  • • 
    82% of men reported being comfortable and 90% being satisfied with their decision to be on AS.
  • • 
    55% reported not being anxious about the cancer progressing while on AS.
  • • 
    Urologist’s opinion, current age, and impact of treatment on urinary function were main factors influencing treatment decision.
  • • 
    Information on future treatment options, non-traditional treatments and diet considered most important resources.

CONCLUSIONS

  • • 
    Results suggest that once men make a decision to go on AS, they are satisfied with their decision and few report being anxious about progression of cancer.
  • • 
    Men are strongly influenced by the treating specialist in taking up AS.
  • • 
    Additional information and psychological support resources are required for men on AS.

Abbreviation
AS

active surveillance.

INTRODUCTION

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. ACKNOWLEDGEMENTS
  8. CONFLICT OF INTEREST
  9. REFERENCES

Prostate cancer is a heterogeneous disease, and the risk of mortality from localized disease is difficult to quantify given the slow rate of growth. Although more than half of men are diagnosed with asymptomatic low-risk prostate cancer [1], 90% receive some form of curative therapy [2]. The optimal treatment for low-risk prostate cancer remains unclear because there is a lack of convincing evidence regarding which treatment offers the best long-term survival. Although each treatment has specific adverse effects that impact quality of life, there is growing evidence suggesting that active surveillance (AS) provides a means of reducing the adverse effects associated with current treatments [3]. The dilemma of whether to treat or not to treat is one of the most difficult decisions facing patients with prostate cancer that is confined to the prostate.

Active surveillance is a management strategy that offers patients the hope of avoiding unnecessary treatment without detriment to long-term survival [3]. By definition, AS is the systematic monitoring of men with low-risk prostate cancers with the aim to treat tumours at predetermined thresholds that define progression with the intent to cure [4], and in those patients who have a life expectancy of less than 10 years [5]. Patients on AS usually have tumours perceived as being low risk in both progression and mortality. Inclusion criteria vary in the literature, but patients on AS usually have T1–T2 tumours, Gleason scores of ≤7, and a PSA level below 15–20 ng/mL. To date, there is no consensus regarding the best AS protocol, eligibility criteria, and method for monitoring the disease condition during follow-up.

Psychosocial issues in response to non-intervention such as anxiety and uncertainty related to loss of control are major reasons why men decide to treat their low-risk prostate cancer at the time of diagnosis [6]. However, it is estimated that half of all men with prostate cancer detected as a result of an abnormal PSA screen receive unnecessary treatment [7]. It is apparent that to maximize uptake of AS with minimal adverse impact on the patient’s psychosocial functioning we need to determine how these men are making the decision to undergo AS, to identify how this form of surveillance is impacting on their lives, and to identify what types of resources are required to support them in their decision.

This study examined the decision-making processes used by men when choosing AS, and the resources they want to make, support and sustain them in their decision. Specific objectives of this study were to: (i) identify the role men assumed in making a treatment decision to be on AS; (ii) identify factors with an influence on the decision to go on AS; and (iii) identify resources that men wished to access while on AS. A secondary aim of this study was to verify the results of a qualitative study conducted with a group of 25 men on AS [8,9].

PATIENTS AND METHODS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. ACKNOWLEDGEMENTS
  8. CONFLICT OF INTEREST
  9. REFERENCES

This cross-sectional descriptive study was approved by the research ethics committees of both the University of British Columbia and the Vancouver General Hospital in Vancouver, Canada. Between July 2009 and March 2010, all patients who had a diagnosis of early stage prostate cancer and were on AS for ≤10 years were included in this study. Patients had to fulfil all of the following criteria to be eligible: histologically confirmed adenocarcinoma of the prostate; clinically localized prostate cancer (T1–2, NX or NO, MX or MO); no previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery or chemotherapy); and patient-elected AS as the preferred management plan for prostate cancer. Exclusion criteria were mental disorders and insufficient knowledge of the English language.

A previous study used semi-structured interviews of 25 men diagnosed with low-risk prostate cancer to explore the role they reported assuming with their physician in making a decision to go on AS, factors having an influence on the decision to go on AS, and the resources men wished to access to support them while on AS [8]. All men in this latter study were recruited from the British Columbia Cancer Agency and the Vancouver Prostate Centre Clinic British Columbia in 2007 to 2008. Questions included in the three-part survey questionnaire used in this study were based on the results of this qualitative study [8]. Part one of the survey asked about who recommended that the patient should go on AS, and types of physicians seen to discuss treatment options. The five statements of the Control Preferences Scale were used to identify the role patients assumed in making the decision to go on AS. The Control Preferences Scale has previously been used by Davison et al. [10–12] in several studies with populations of men with prostate cancer. The five statements were collapsed into three roles from playing: an active role with the urologist, a shared or collaborative role with the urologist, or a passive role where the urologist made the decision. A five-point Likert Scale (0 = not at all to 4 = a great deal) was used to measure the similarity of this treatment decision to other life decisions, difficulty of decision to go on AS, comfort level being on AS, and current level of anxiety being on AS. A five-point Likert Scale (0 = strongly disagree to 4 = strongly agree) was used to measure if the patient felt he had received enough information to make a treatment decision to go on AS, and overall satisfaction with the decision to be on AS. A yes/no question was used to determine the impact that AS was having on current daily activities.

Part two of the survey measured the impact of 14 factors on the participants’ decision to go on AS. These factors were identified in the qualitative study as being the main variables impacting on patients’ decisions to go on AS [8]. Participants were asked to rank each of these factors on a five-point Likert Scale (0 = not at all to 4 = a great deal): current age; impact of treatment on my sexual function; impact of treatment on my urinary function; time needed to recover from treatment; advice from my partner/spouse; advice from friends who were treated for prostate cancer; my urologist’s opinion; advice from another medical specialist (e.g. radiation oncologist); advice from my family practitioner; my current health (medical conditions that I have); financial concerns while off work after treatment; need to have a regular PSA blood tests to monitor if prostate cancer is progressing; need to have regular biopsies to see if the prostate cancer is progressing; and belief that my urologist will spend more time with me if I am on AS.

Part three of the survey was used to measure the patients’ needs for additional support services while on AS. This section used a five-point Likert Scale (0 = not at all to 4 = a great deal) to assess the following factors: information about eating a prostate-friendly diet; need to talk with other men on AS; opportunity to learn more about the use of non-traditional treatments while on AS; information about future treatment options; need to attend support group meetings for only men with AS; ability to join an anonymous Internet-based support group for men on AS; and participation in an exercise programme while on AS designed for men with low-risk prostate cancer. Men were also asked to include other topics of importance to them or resources they wanted to access.

A short demographic section solicited information on the participant’s age, marital or relationship status, ethnicity and employment. Date of diagnosis and other disease-relevant information was obtained from the patient’s records.

Physicians provided the names of patients meeting the criteria to the researcher (BJD). Letters of invitation to participate in this study along with a consent form and questionnaire were mailed to all eligible patients along with a self-addressed stamped envelope. Patients were contacted by a research assistant after 2 weeks as a reminder to complete the questionnaire.

Mainly descriptive statistics (frequency tables, means and standard deviations) were used in the analyses of this survey-based study. Chi-squared tests were used to determine if a relationship existed between assumed role in treatment decision-making, demographics, factors having an influence on the treatment decision, and need for additional support services. One-way anova was used to measure the influence of time since diagnosis on assumed role in decision-making, and factors influencing the decision to go on AS. Paired Student’s t tests were used to determine the influence of patient’s current levels of anxiety on need for support services and factors influencing the treatment choice. A P value of 0.05 was used to determine significance for all analyses.

RESULTS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. ACKNOWLEDGEMENTS
  8. CONFLICT OF INTEREST
  9. REFERENCES

During the inclusion period, the survey questionnaire was sent to a total of 121 patients, and 73 (60%) of these participated in the study. Participants were on average 64.49 years (sd 7.44) of age at the time of diagnosis. The mean length of time since diagnosis was 2.82 years (sd 2.37) and 87.7% of men had been on AS for less than 5 years. The sample was recruited from one large academic urology clinic with 95% of subjects being seen by two of the urologists practicing in this centre. Most patients were Caucasian, married and university educated. The patients’ personal and disease characteristics are categorized in Table 1.

Table 1.  Baseline characteristics of study participants (N= 73)
Variablen (%)
  1. PSA, prostate-specific antigen.

Age (years) 
 ≤6022(30.1)
 61–7037 (50.7)
 >7014 (19.2)
Educational attainment: 
 < high school9 (12.3)
 High school13 (17.8)
 Trade/community college15 (20.5)
 University36 (49.4)
Marital status 
 Married/cohabitating60 (82.2)
 Single13 (17.8)
Employment 
 Full-time19 (26.0)
 Part-time9 (12.3)
 Retired45 (61.6)
Ethnicity 
 Caucasian63 (86.3)
 Asian10 (13.7)
Years since diagnosis 
 ≤5 years64 (87.7)
 >5 years9 (12.3)
PSA level (ng/mL) 
 <1063 (86.3)
 10–208 (11.0)
 >202 (2.7)
Gleason score 
 54 (5.5)
 666 (90.4)
 73 (4.1)
Clinical stage 
 T149 (67.1)
 T224 (32.9)

Active surveillance was the treatment recommended by most (84%) urologists. Surgery was suggested as a treatment option to approximately one-third of patients, and radiation was suggested to 10% of patients. Most (77%) patients were not referred to a radiation oncologist for a second opinion. Age was not found to be a significant factor influencing the recommendation to go on AS, but a significantly higher proportion (χ2= 13.15; P= 0.001) of men aged 60 years or less were given the recommendation to have surgery. Education attainment and marital status were not found to have an impact on the treatment recommended by the urologist.

Forty-one per cent of men reported assuming a ‘shared’ or collaborative role in making the decision to go on AS, 27% reported an active role, and 32% reported that the urologist made the treatment decision. A significantly higher proportion (χ2= 9.66; P= 0.047) of men 70 years of age and older had a preference to play a passive role in treatment decision-making compared with men in either the active or collaborative groups. Level of education, employment status, marital status and time since diagnosis were not found to have a significant impact on patients’ assumed roles in treatment decision-making.

Most (>75%) of the men reported that the decision to go on AS was similar to other life decisions; the decision was not difficult; and they were comfortable being on AS. Over half (55%) of participants reported having low levels of anxiety about the prostate cancer progressing while on AS (Table 2). Approximately 90% of patients also reported that: they had received all the information necessary to make the decision to go on AS; they were satisfied with their decision to be on AS; and AS was not having any impact on their usual daily activities.

Table 2.  Psychosocial factors influencing active surveillance (AS) decision (N= 73)
Survey itemsn (%)
Not at allVery littleSomewhatModerate amountA great deal
1. AS decision similar to other life decisions3 (4.3)4 (5.7)10 (14.3)18 (25.7)35 (50.0)
2. Difficulty of AS decision36 (50.0) 11 (15.3)5 (6.9)16 (22.2)4 (5.6)
3. Comfortable being on AS2 (2.7)1 (1.4)8 (11.0)17 (23.3)45 (61.6)
4. Anxiety about prostate cancer progressing while on AS22 (30.1)18 (24.7)19 (26.1)12 (16.4)2 (2.7)

The four main factors having an impact on participants’ decision go on AS were: urologist’s opinion, current age, impact of treatment on urinary function, and impact of treatment on sexual function (Table 3). The influence of partners/spouses was ranked higher than advice from the family doctor, another medical specialist, and friends previously treated for prostate cancer. Time since diagnosis did not have a significant impact on any of these factors as measured by a one-way anova.

Table 3.  Factors influencing treatment decision (N= 73)
FactorMean (SD)*
  • *

    Lower means indicate lower level of importance. PSA, prostate-specific antigen.

My urologist’s opinion3.19 (1.24)
Current age2.38 (1.49)
Impact of treatment on urinary function2.26 (1.42)
Impact of treatment on sexual function1.89 (1.49)
Need to have regular biopsies1.75 (1.54)
Advice from partner/spouse1.59 (1.49)
Belief urologist will spend more time with me1.55 (1.44)
Time needed to recover from treatment1.55 (1.38)
Need to have a regular PSA test1.53 (1.74)
Advice from my family doctor1.48 (1.55)
My current health status1.30 (1.41)
Advice from another medical specialist1.07 (1.50)
Advice from friends treated for prostate cancer0.89 (1.06)
Financial concerns while off work for treatment0.37 (0.84)

Three factors were identified as having a significant impact on the decision to go on AS based on level of anxiety. Compared with participants (n= 40) who reported ‘none’ to ‘very little’ levels of anxiety over being on AS, participants (n= 33) who reported having levels of anxiety ranging from ‘somewhat’ to ‘a great deal’ reported that current age (t= 4.51, P≤ 0.001), advice from my family doctor (t= 2.73, P= 0.008) and current health (t= 2.05, P= 0.04) were significantly more important.

The top four resources identified by participants as being important while on AS were receiving information on future treatment options for prostate cancer, non-traditional or complementary treatments, eating a prostate-friendly diet; and participation in an exercise programme for men on AS. Table 4 lists the participants’ ratings of additional support services while on AS. No additional resources were identified as being important. Time since diagnosis and current level of anxiety were not found to have an impact on the need to access these additional supports.

Table 4.  Need for additional support services or resources (N= 73)
Survey itemsn (%)
Not at allVery littleSomewhatModerate amountA great deal
  1. AS, active surveillance.

1. More information on future treatment options8 (11.0)4 (5.5)9 (12.3)12 (16.4)40 (54.8)
2. More information on non-traditional treatment options12 (16.4)9 (12.3)14 (19.2)18 (24.7)20 (27.4)
3. More information on eating a ‘prostate-friendly diet’14 (19.2)8 (10.9)14 (19.2)18 (24.7)19 (26.0)
4. Participation in an exercise programme for men on AS19 (26.4)3 (4.2)23 (31.9)12 (16.7)15 (20.8)
5. Need to talk with other men on AS30 (41.1)17 (23.3)14 (19.2)9 (12.3)3 (4.1)
6. Web-based anonymous support group for men on AS37 (50.7)13 (17.8)12 (16.4)7 (9.6)4 (5.5)
7. Separate support group for men on AS36 (49.3)16 (21.9)11 (15.1)8 (11.0)2 (2.7)

Four support services were also identified as being important for participants with higher levels of anxiety while on AS. Compared with participants (n= 40) who reported ‘none’ to ‘very little’ levels of anxiety over being on AS, participants (n= 33) who reported having levels of anxiety ranging from ‘somewhat’ to ‘a great deal’ reported that talking to other men on AS (t= 3.33, P= 0.001), receiving information about future treatment options (t= 2.18, P= 0.03), having a support group for men on AS (t= 2.38, P= 0.02), and joining a web-based anonymous support group for only men on AS (t= 2.44, P= 0.01) as being important.

DISCUSSION

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. ACKNOWLEDGEMENTS
  8. CONFLICT OF INTEREST
  9. REFERENCES

This study was able to provide insight into how a group of men on AS made their decision to be on AS, how they were coping with being on AS, factors having an influence on their decision to be on AS, and information resources they currently wanted to access

Previous research has shown that most men diagnosed with prostate cancer report assuming either active or collaborative roles in medical treatment decision-making [10,12,13]. Similarly, most men in this study reported assuming either an ‘active’ or a ‘shared’ role in treatment decision-making. However, approximately one-third of participants reported that the urologist had played the main role in treatment decision-making. This was especially relevant to men over 70 years of age compared with their younger cohorts. This finding was in contrast to the previous qualitative study [8] in which men of all ages reported being active participants in the decision to go on AS. One explanation for this divergence is that men in this study relied on their urologist’s recommendation and they did not believe a decision had to be made until the cancer progressed. Another reason may be a result of the way in which assumed role was measured. Men in this study were asked to choose the one statement of the Control Preferences Scale that best described the role they played in making a treatment decision with their urologist, whereas in the qualitative study men were asked to describe how they participated in the treatment decision-making. The anonymous reporting of assumed role in treatment decision-making used in this study is also believed to have had an impact on their responses.

The perceived threat of cancer and the meaning that patients ascribe to their disease can create feelings of anxiety [14], especially when the patients are coping with the inherent uncertainty of living with an untreated cancer [9]. To date, most studies do not consider that asymptomatic men living with untreated prostate cancer might experience psychological distress [15]. The relatively high ‘drop-out’ rate from AS [16] also may be related to the anxiety associated with the close monitoring and natural fluctuations in PSA levels, and uncertainty of disease progression. In an evaluation of men undergoing AS, Patel et al. [17] found that 8% of men with no evidence of cancer progression were given active treatment because they had significant anxiety about living with cancer and the possibility of progression. A similar number of men also received treatment because of a combination of anxiety and physician concern about possible (as opposed to definite) progression. The men in our study reported being comfortable and satisfied with their decision to be on AS, and felt well informed. However, 45% of the participants reported experiencing some degree of anxiety about the prostate cancer progressing while on AS. Further research is required to identify levels of anxiety in this group of patients using a validated questionnaire. The one question used in this study was not able to adequately identify the anxiety that these men were experiencing or the impact it was having on factors influencing the treatment decision and resources required to support them in their decision. There is also a need to measure the impact of psychological support services on patients seeking active treatment in the absence of disease progression.

The physician’s recommendation was identified as having the most influence on the decision for men to be on AS. This finding was similar to other studies where most patients with prostate cancer also reported that the physician had the most influence on their final treatment decision [8,18–21]. Although patient age, marital status and type of specialist seen have previously been identified as having an influence on treatment decisions of men with low-risk prostate cancer [22], this finding was not shown in this study. Patients in our study continued to rely on the expertise of their specialist in deciding which treatment option was best for them.

Patients in our study reported their age at the time of diagnosis as being important to their decision to go on AS, and surgery was suggested more often to younger than older men. Perhaps surgery was suggested to these younger men because the best prognosis after a prostate cancer diagnosis is among those men aged between 50 and 69 years [23]. Similarly, Bill-Axelson et al. [24] reported that when comparing watchful waiting with radical prostatectomy, the 10-year absolute differences in disease-specific and overall mortality were significant in favour of radical prostatectomy. A recent analysis of the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) database reported that of the 16% (n= 310) of men diagnosed with low-risk prostate cancer between 1999 and 2004, only 9% chose AS [25]. Although these men with low-risk disease tended to be younger, white, more highly educated, with a higher income and private insurance; being older was found to be predictive of going on AS. Our results suggest that even physicians who support the concept of AS are more apt to suggest active treatment in younger men. Further research is required to study the impact of patient age on both patient’s and specialist’s comfort levels in undertaking AS.

Patients’ perceptions of the potential toxicity associated with various treatment options can impact treatment choice [6]. Patients in this study identified the adverse effects of urinary incontinence and sexual dysfunction as having an important impact on their decision to go on AS. Most recently, Litwin et al. [26] described the general and disease-specific differences in quality of life after treatment of localized prostate cancer with brachytherapy, external beam radiation and radical prostatectomy, but few if any studies have prospectively compared standard treatments with AS. Patients on watchful waiting (WW) report minimal decreases in their health-related quality of life [27], when compared with those who have received active treatment [28]. The terms WW and AS appear interchangeably in the literature, so it is necessary to separate the two treatment modalities in future quality-of-life studies.

The role played by spouses in the final treatment selection varies in the literature. Some investigators report that despite the fact that spouses want to have input into the final treatment choice, they tend to leave the final decision to their husband [11,13,29]. Conversely, other investigators report that patients feel considerable pressure from their spouse and family members to seek active treatment [30,31]. Our results showed the spouse’s opinion as being more important than other physician’s opinions. This finding supports results in the qualitative study [9] where there were several examples of women partners implementing, monitoring, and collaborating with their men to direct, assess and refine diet protocols to complement AS protocols. This finding shows the importance of including spouses in the AS clinical follow-up.

As more men with low-risk prostate cancer consider AS, it becomes necessary to assess their need for additional information resources. Men in this study identified that they wanted more information about future treatment options, non-traditional or complementary medicine, and eating a ‘prostate friendly’ diet. This finding was in contrast to the qualitative study [8,9] where few patients reported a need for access to additional information and supportive resources while on AS. Clearly these men do have a need for such support services to be put in place. Such services might target a regular update of new treatment options or changes occurring with regard to current treatments; instituting general health promotion activities such as diet and exercise; and open discussions on the role of non-traditional or complementary products while on AS. In addition, it is necessary to provide some form of counselling services for those men who are experiencing anxiety related to having a cancer that is not being ‘actively’ treated. Our results provide healthcare practitioners with a basis to set up supportive programmes for this group of men.

Study limitations include the fact that the survey questionnaire was not validated, but questions were based on the results from a qualitative study conducted with men on AS. Another caveat is that because the data came from a single urology clinic, the findings may not apply to other centres. However, this clinic is a major referral centre for the province of British Columbia so we believe the sample is representative of other large academic urology centres. The cross-sectional design also made it difficult to identify if changes in the parameters measured in this study change over time. Prospective studies are required to determine the changes that occur and the impact of psychosocial interventions on patients’ desire to remain on AS. Another limitation to this study is the need to use a validated questionnaire to measure current levels of anxiety. The findings related to factors influencing the treatment decision and resources based on levels of anxiety should be considered with caution until a validated questionnaire is used to confirm these results.

The challenge of managing early prostate cancer is to differentiate patients with clinically relevant cancers from those whose disease will not impact on future survival. Until we have molecular markers to separate indolent from aggressive prostate cancers, there is a need to reach a consensus on the optimal AS protocol and to provide the necessary support to those men who choose to be on AS; AS remains an emerging area of research.

ACKNOWLEDGEMENTS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. ACKNOWLEDGEMENTS
  8. CONFLICT OF INTEREST
  9. REFERENCES

Funding for this project was provided by the organization ‘Motorcycle Ride for Dad’, BC Chapter. There was no involvement of the funder in study design, data collection, data analysis, manuscript preparation, and/or publication decisions. We are grateful to the following urologists who provided access to their patients for this study: S. Larry Goldenberg, Martin Gleave and Alan So; and to Dr Jonathan Berkowitz for his statistical analysis.

REFERENCES

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. ACKNOWLEDGEMENTS
  8. CONFLICT OF INTEREST
  9. REFERENCES