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Confidence and Uncertainty Long After Initial Treatment for Early Prostate Cancer: Survivors' Views of Cancer Control and the Treatment Decisions They Made

Jack A. Clark, James A. Talcott

From the Center for Health Quality, Outcomes, and Economic Research, Edith Nourse Rogers Memorial Veterans Hospital, Bedford; Boston University School of Public Health; Center for Outcomes Research, MGH Cancer Center, Massachusetts General Hospital; and Harvard Medical School, Boston, MA

Address reprint requests to Jack A. Clark, PhD, Department of Health Services, Boston University School of Public Health, 715 Albany St, T3-W, Boston, MA 02118; e-mail: jaclark{at}bu.edu

	ABSTRACT

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PURPOSE: The many years most men diagnosed with early prostate cancer live after diagnosis allow evolving assessments of their cancer control and their treatment choices, but little is known of these outcomes or the factors that influence them.

PATIENTS AND METHODS: We surveyed an established, prospective cohort that had initiated treatment for early prostate cancer 4 to 8 years previously. We assessed perceived cancer control, quality of treatment decisions, and other domains of quality of life, along with treatment-related urinary, bowel, and sexual dysfunction.

RESULTS: Most men reported high confidence in cancer control and their treatment decisions, but many reported misgivings about one or both. The diagnostic, treatment, and quality-of-life factors associated with these two outcomes were distinct. Perceived cancer control was lower among those with adverse medical factors: higher pretreatment Gleason scores, subsequent rises in prostate-specific antigen (PSA), and secondary androgen ablation therapy. Confidence in treatment decisions was unrelated to these factors and was higher in men who opted for radical prostatectomy or brachytherapy, reported close attention to current PSA, had high masculine self-esteem and little distress from sexual dysfunction, and were married.

CONCLUSION: Although perceptions of cancer control and the quality of their treatment decisions are linked, men can distinguish between these two outcomes. They incorporate objective indicators of high risk and adverse outcomes when assessing their cancer control; confidence in treatment decisions represents a more complex psychosocial adjustment to the persistent uncertainty that originates with their diagnosis.

	INTRODUCTION

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Patients with the diagnosis of early prostate cancer live with uncertainty about whether their treatment has succeeded and may second guess their decision to undergo it. The goal of primary treatment is to prevent the metastases that may lead to death, a decisive progression that the patient and physician cannot observe. The diagnosis forces men to face a crucial health decision under difficult circumstances: the range of treatment choices is unusually broad; the physical consequences of treatment are serious and long lasting; and the decision, they are told, is necessarily theirs to make, not the doctor’s. The decision may be daunting.^1,2,3 Evidence suggests that active treatments prolong life at most modestly compared with initial observation. However, doing nothing is rarely an attractive option, despite the morbidity it may spare, and physicians infrequently present it with enthusiasm to men with prostate cancer.^2,4 Each active treatment brings risks of long-term adverse physical effects in a distinctive pattern that threatens quality of life, creates anxiety, and complicates discussion. Compounding the uncertainty, different physicians’ advice often conflicts.⁵ Patients cannot be certain that, under stress and with incomplete information, they made the right treatment decision. Because the natural history of prostate cancer is long and progresses late, most patients experience their cancer’s course and reflect on their choices for many years. We studied how prostate cancer survivors experience these uncertainties and the factors associated with their perceptions.

Most prostate cancer patients report satisfaction with their treatment and would make the same decision again.^6,7 Yet misgivings about how decisions were reached may accompany this satisfaction.⁸ With new information and time to reflect, feelings may change. During their clinical course, patients may encounter unexpected complications or obtain evidence of less certain cancer control than anticipated.⁹ Regret is not rare, reported by 16% of men 2 to 4 years after primary treatment and associated with sexual dysfunction and poorer quality of life.^10,11 Confidence in one’s choices may be provisional, and exploring the reasons for doubt informative.

	PATIENTS AND METHODS

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We assessed men’s confidence that their cancer was under control and that their treatment decisions were well informed 4 to 8 years after they had reached decisions on primary treatment for early prostate cancer. We explored associations between these outcomes and other measures of prostate cancer-related quality of life, along with previously assessed clinical prognostic factors, treatment received, and bodily adverse effects of treatment.

Subjects
We surveyed men who had completed participation in an ongoing, prospective observational study of outcomes of primary treatment for early prostate cancer, initiated in June 1994. Details of the design of that study have been reported previously.^12,13 It monitored urinary, bowel, and sexual dysfunction before and 3, 12, 24, and 36 months after the initiation of primary treatment. Seventy-five percent of the patients approached had been successfully recruited, 15% dropped out before the 3-month follow-up, and annual attrition averaged 6.5%. As of March 2002, 295 participants in that study had completed all planned assessments and were eligible for the current study; 19 could no longer be located, and seven were deceased. Thus, new follow-up questionnaires were sent to 269 men. Informed consent was reobtained, with approval by our respective institutional review boards.

Questionnaire
The questionnaires included new measures of prostate cancer–related quality of life developed in a previous study of patient outcomes, details of which, including psychometric analyses and scale content, have been reported.^11,14 These measures were multi-item Likert scales, developed through qualitative analyses of men’s perceptions of treatment outcomes and a survey of a diverse sample of patients and a non–prostate cancer comparison group. The outcomes of interest here were measured by two scales. Cancer Control assessed confidence that one’s cancer is under control, worries about recurrence, and misgivings about the efficacy of treatment. Informed Decision addressed perceptions of having sufficient information when choosing a treatment, being fully informed by one’s doctors, and experiencing satisfaction with one’s choices.

Nine other scales assessed psychosocial domains of prostate cancer-related quality of life.¹² Behavioral and emotional effects of urinary and bowel dysfunction were assessed by Urinary Control and Bowel Control. Multiple effects of sexual dysfunction were assessed by Sexual Intimacy (eg, lack of awkwardness with intimacy), Sexual Confidence (eg, comfort with sexuality), and Masculine Self-Esteem (eg, rejecting personal inadequacy and feelings of being less than a "whole man"). Concerns about intimate partner relationships were assessed by Spouse Affection. Apprehensiveness about future health problems was assessed by Health Worry, while attention to prostate-specific antigen (PSA) and the comfort of knowing one’s PSA level were assessed by PSA Concern. Summary appraisals of the success of one’s coping with prostate cancer were assessed by Outlook. Regret assessed feelings of having made the wrong treatment choice of treatment and a wish to undo that decision. High scores (range, 0 to 100) on all 11 scales indicated better quality of life, except for Health Worry and PSA Concern, where high scores indicated greater worry or concern, and Regret, which was dichotomized. The previously reported strong psychometric properties of these scales were reconfirmed with the new survey data before the planned analyses.¹⁴

Treatment-related urinary, bowel, and sexual dysfunction were measured in this follow-up by the same symptom indexes used in the previous assessments of this cohort.¹⁵ The new questionnaire added the symptom bother scales of the Expanded Prostate Index Composite.¹⁶ Functional status was assessed by the Physical and Mental Component Summaries of the SF-36.¹⁷ Measures of Marital Function and Social Support were also adapted from the Medical Outcomes Study.¹⁸ Feelings of being "odd or different" were assessed by Stigma.¹⁹ Additional items assessed satisfaction with care and patients’ views of responsibility for their choice of treatment.

Pretreatment PSA, Gleason score, stage, and primary treatment had been obtained from medical records. Patients who initiated no active treatment for 6 months after diagnosis were determined to have chosen continued observation. Treatments received subsequent to the first 6 months after diagnosis, including androgen deprivation (ie, a long-term course of hormone treatment and orchiectomy) and treatments received at sites other than those where study participants had been recruited, and PSA levels subsequent to primary treatment were documented by self-report in the new questionnaire.

Statistical Analysis
We examined variation in Cancer Control and Informed Decision. Most men scored at the high ends of both scales, as we had found in a previous study.¹¹ Alternatives for dealing with dependent variables distributed this way include reducing them to dichotomies, at some sacrifice of information, and logarithmic or other transformations, which complicate interpretation. We opted to reduce both outcomes to three-level ordinal measures. Scores 80 or greater were "high," 60 to 79 were "medium," and less than 60 was "low." "High" indicates strong endorsement of expressions of cancer control or informed decisions; "low" indicates equivocal endorsements or rejections of such expressions.

We evaluated associations between these two scales and demographics, diagnostic variables, treatment, subsequent PSA, urinary, bowel, and sexual dysfunction and bother, and prostate cancer–related quality of life, using ², the median test, and correlation coefficients, as appropriate for categoric and continuous variables. The joint effects of these variables were evaluated with ordered logistic regression. Models for each outcome were built in four steps. First, we evaluated the effects of demographic, diagnostic, and treatment variables with at least marginally significant (P < .10) univariate associations with the outcome, and retained those with significant coefficients (P < .05). Second, we added the symptom indexes and symptom-bother scales to the variables retained from step 1. Third, we added measures of prostate cancer-related quality of life. Fourth, we included measures of overall functional status and well-being, health perceptions, stigma, and social support.

	RESULTS

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Notwithstanding the passage of 1 to 5 years since completing the previous cohort study, 235 men (87%) responded to the new follow-up. Ten men refused, three because of illness, and 24 failed to respond. Respondents and nonrespondents were compared with respect to age, education, marital status, pretreatment PSA and Gleason score, primary treatment, adverse physical effects, and overall physical and mental health as of their last (36-month) follow-up. There were no significant differences except that respondents had reported worse sexual dysfunction 36 months after treatment (t = 2.62; P = .009).

At diagnosis, more than half of the respondents had reassuring Gleason scores ( 6), and only 10% had high-grade tumors ( 8; Table 1). Most had undergone either prostatectomy or external beam radiation; 18% pursued brachytherapy, most of whom were accrued late during the study’s extension to sample its local reemergence in the late 1990s. Salvage androgen deprivation therapy was reported by 15%. One fourth reported the ominous sign of a rising PSA after primary therapy, but 66% reported a currently stable PSA, which for 37% was undetectable.

Both cancer control and confidence in treatment decisions were positively associated with treatment satisfaction. Conversely, diffidence in decisions was markedly associated with frank regret. Although only 7% overall expressed regret, 23% of those who felt their treatment decisions were poorly informed wished they had chosen a different approach. Men with little confidence in their treatment decisions also attributed more responsibility to their doctors: 23% of the least confident compared with 8% of the most confident indicated that "mostly my doctor" decided.

Perceived cancer control was inversely correlated with the Gleason scores of their original pretreatment biopsies, the most important prognostic factor. Patients with Gleason scores greater than 6 were twice as likely to report low Cancer Control (Table 2). Other unfavorable prognostic factors, PSA level at diagnosis and clinical stage, were also aligned with reduced cancer control, although not significantly. However, patients appreciated that rising post-treatment PSA bodes poorly. Perceived cancer control was not significantly associated with primary treatment approach, but it was substantially diminished among survivors who reported subsequent androgen deprivation treatment.

Both outcomes were associated with the severity of treatment adverse effects and quality of life (Table 3), which in turn may be influenced by age, pretreatment function, and treatment choice. Pretreatment bodily function had little effect, except for sexual dysfunction; men with less confidence in cancer control and their treatment decision at follow-up had reported slightly greater sexual dysfunction before treatment. Current dysfunction appeared more relevant. Greater current urinary obstruction, but not incontinence, and bowel problems were associated with poorer scores on both outcomes and sexual dysfunction with lower confidence in decisions. Health Worry, which indicates apprehensiveness about possible bad medical news, including cancer recurrence, was strongly correlated with perceived cancer control (r = –.56). Surprisingly, preoccupation with PSA, PSA Concern, was unrelated to perceived cancer control, but positively associated with confidence in decisions. Sexual Confidence and Marital Function were associated with both outcomes, but more closely with confidence in treatment decisions. Behavioral and emotional problems of Bowel Control were associated with misgivings about cancer control.

We constructed multivariable models to examine the joint effects of these variables on Cancer Control and Informed Decision. To illustrate the effects of including Health Worry, we present the final two models for each outcome (Tables 4 and 5). Indicators of an initial poor prognosis (Gleason score 7) or adverse events after treatment (androgen deprivation therapy and evidence of PSA failure, both any PSA rise after and a currently rising PSA) were strongly associated with diminished confidence in Cancer Control. Bother with bowel symptoms and sexual confidence were also associated with lesser and greater cancer control, respectively. However, when Health Worry was added, the associations with both of these variables disappeared.

	DISCUSSION

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Outcomes research is intended to support informed prostate cancer treatment decisions, but few studies have examined how men feel about their decisions and understand their medical course in the long-term.²⁰ We distinguished men’s natural preoccupation with whether treatment succeeded from their ongoing reassessments of the process through which they selected it. Men’s perceptions reflect their medical starting place, the milieu in which they chose their treatment and experienced its aftermath, the treatment-related dysfunction they experience, and markers of their cancer course. Our data are limited by the lack of prior, prospective assessments of these men’s perceptions of their cancer and their decisions, and thus we could not examine changes in confidence or misgivings over time, as adverse effects emerged and perceptions matured. Yet our follow-up of this cohort has provided a unique opportunity to explore how long-term survivors perceive these outcomes and their current quality of life, in conjunction with previously documented clinical facts, decisions, and outcomes.

Most of these men were comfortable that their cancer was controlled and confident they chose their treatment well, despite substantial urinary, bowel, and sexual dysfunction arising from it and persisting long after the 24-month follow-up we reported earlier.¹³ Treatment-related bodily dysfunction alone, which diminishes quality of life, does not affect men’s belief that their prostate cancer is controlled or their confidence in their treatment decisions made years before. Our results suggest that men perceive cancer control and their treatment decisions separately, and different factors affect each. Men correctly interpret the information they reported to us about their cancer prognosis and course; adverse prognostic factors and clinical events appropriately reduced their confidence that their cancers were under control. What is surprising and gratifying is that men’s assessments of their treatment decisions do not depend on the outcome of treatment. Men can distinguish between what they can control and what they cannot.

Confidence that one’s cancer is controlled should reinforce the belief that one had made a good treatment decision, while misgivings about cancer control undermine it. Conversely, eroding confidence that the treatment decision was good, perhaps in response to treatment adverse effects or new information about options either chosen or foregone, might precipitate worry that they had overestimated their chosen treatment. Yet, our results indicate that men do not require minimal toxicity or definitive cancer control to conclude that they made the best decision given the circumstances in which they were forced to choose.

Men’s perceptions of cancer control reflected their clinical risk at diagnosis, their test results after treatment, and the need for further treatment. A biopsy indicating an aggressive cancer, PSA evidence of progression after treatment, and the initiation of androgen ablation appropriately lowered their confidence that their cancers were controlled. Factors other than these clinical indicators determined how men viewed their treatment decisions. If confidence in the decision waned with the passing years, evidence of unsuccessful treatment or physical complications was not the cause. Tracking outcomes closely using PSA level, measured by PSA Concern, did not indicate less confidence of cancer control, but greater confidence in their treatment decisions. Not the focus on measuring, but the disappointing result influenced men’s perceptions of cancer control.

Men with prostate cancer are anxious about recurrence, and a rising PSA confirms their fears. In the CaPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor) cohort, fears aroused by the diagnosis subsided after undergoing active treatment, but 24 months later many, particularly those reporting relatively poor functional status, feared recurrence.²¹ In Medicare patients surveyed 6 years after radical prostatectomy, rises in PSA and secondary androgen ablation therapy were associated with increased worry about cancer and diminished well-being.²² In our study subjective perceptions of cancer control appeared well-founded in objective clinical circumstances.

Despite the PSA test’s potential for unsettling news, reassuring PSA values may reinforce men’s confidence in their treatment decisions. PSA tests may be recurrent sources of anxiety for men with metastatic prostate cancer, although in that circumstance the prospect of death, the diminished treatment options, and fear of the unknown were more potent.²³ Nevertheless, ceasing PSA testing may provoke anxiety, leaving men feeling abandoned by their doctors and worried that their doctors lacked information to guide their treatment.²³ In our study, close attention to PSA signaled greater confidence in their treatment decisions. Whether closely attended PSA results improve confidence in one’s treatment decision or confidence in one’s decision allows closer attention to PSA is unclear.

Our exploration lacks data on how men originally perceived their diagnosis, treatment choices, and interaction with their doctors. Yet, our findings may give insight into treatment decisions that are often portrayed as opposing potential cure against preserving quality of life. Men who undergo radical prostatectomy or brachytherapy have better prognoses than do those receiving external beam radiation therapy, but in our patients, the chosen treatment influenced confidence in the treatment decision but was largely unrelated to perceived cancer control. Men may gain confidence from definitive surgical excision and the high radiation dose brachytherapy delivers to the prostate.^4,24 But these plausible advantages do not outweigh clinical events that denote incomplete cancer control, such as negative PSA results or the institution of salvage androgen deprivation therapy. Confidence in the decision may arise from simply having surgery and brachytherapy as options, rather than withheld because their doctors judge that patients are too old or their cancers too advanced. Their range of choices may frame how men acquire and process information about potential treatments. How men perceive their options, what they take into account as informing their decisions, and the outcomes they expect, or wish for, need further examination.

Treatment-related sexual dysfunction and related blows to masculine self-esteem may diminish confidence in their original evaluation of the trade-offs they faced, whereas perceived success in coping with cancer and the adversity it brings may bolster self-esteem, overcoming the collateral damage. Preserved self-esteem in the face of sexual dysfunction may also be a marker of global self-confidence. The effects of marital status and social support suggest that confidence grows with successful adjustment to the costs of treatment, aided by partners and supporters. Assuming responsibility for choosing a treatment for early prostate cancer may be intimidating. Faced with a medical crisis, many quite reasonably prefer collaborative decisions with guidance from their doctors.^25,26 Our data document the persistent challenge men face, their ability to preserve cognitive clarity as they cope over time, and the value of support in the process. The task for physicians is to provide their patients the factual information they need, the collaboration that helps them make livable decisions, and the encouragement that they seek, and to nourish the support they will rely on in the years to come.

	Authors' Disclosures of Potential Conflicts of Interest

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION Authors' Disclosures of... Author Contributions REFERENCES

 
The authors indicated no potential conflicts of interest.

	Author Contributions

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION Authors' Disclosures of... Author Contributions REFERENCES

 

Conception and design: Jack A. Clark, James A. Talcott Financial support: Jack A. Clark Provision of study materials or patients: James A. Talcott Collection and assembly of data: Jack A. Clark Data analysis and interpretation: Jack A. Clark, James A. Talcott Manuscript writing: Jack A. Clark, James A. Talcott Final approval of manuscript: Jack A. Clark, James A. Talcott

 

	NOTES

 
Supported by Grant No. DAMD 17-01-1-0026 from the US Department of Defense.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

	REFERENCES

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Submitted February 27, 2006; accepted July 21, 2006.

This Article Abstract Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Clark, J. A. Articles by Talcott, J. A. Search for Related Content PubMed PubMed Citation Articles by Clark, J. A. Articles by Talcott, J. A.