Treatment Decision Making in Early-Stage Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00196781|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : January 13, 2010
|Condition or disease||Intervention/treatment||Phase|
|Localized Prostate Cancer||Behavioral: CD-ROM-based prostate cancer treatment education Behavioral: CD-ROM-based prostate ca treatment education+decision tools||Phase 3|
Background: There is a controversy in the medical community surrounding the utility of treatment options for clinically localized prostate cancer. Although several options are available for management of localized prostate cancer, no option is clearly superior to others. The main therapeutic options for localized prostate cancer include radical prostatectomy (RP), radiation therapy (RT; external beam radiation or brachytherapy), and expectant management (EM) or "watchful waiting." The American Urological Association, after a structured review of the available literature, concluded that there is insufficient evidence to clearly recommend RP, RT, or EM. They recommended that factors such as life expectancy, current health, and patient preference for therapeutic options be considered in the treatment decision. Since the survival benefits of the different management strategies are as of yet uncertain, and men's preferences for outcomes of therapy may influence the decision regarding management choice, men should be informed of potential outcomes and should be encouraged to examine their own values in deciding upon a management strategy for their prostate cancer.
Objective: The primary goal is to evaluate a method of patient education that is designed to provide treatment-related information and to help men clarify their preferences and values via a recently developed computer-based decision aid. We expect that men randomized to the decision aid condition will be more active in their treatment decision and will have improved patient outcomes relative to men assigned to the Information only condition.
Specific Aims. The specific aims are: 1) To evaluate the relative impact of providing newly diagnosed patients with computer-based prostate cancer treatment information vs. providing patients with the information plus an interactive decision-aid on a) shared decision-making practices and b) patient outcomes (decisional satisfaction, quality of life, knowledge), 2) To explore the mechanisms by which the decision aid impacts on SDM and patient outcomes, and 3) To identify men who are most and least likely to benefit from the education plus decision-aid intervention.
Study Design: Men will be accrued at the time of their biopsy and those with a positive biopsy result will receive the intervention following notification of the diagnosis but prior to their initial meeting with the urologist in which treatment options are discussed. Participants will be followed at one, six and twelve months post-intervention. The primary outcomes include patient outcomes (knowledge, quality of life, and decisional satisfaction) and shared decision making (SDM) practices.
Relevance In many areas of medicine, including treatment of localized prostate cancer, there has been a rapid expansion of research that has resulted in a growing number of diagnostic and treatment options that are available to physicians and patients. In many cases, there are several effective and viable treatment options, but randomized clinical trials assessing treatment effectiveness have not yet been completed. Although the availability of different options will undoubtedly be beneficial in the long run, at present it creates a difficult decision for individuals and physicians who are faced with the choices for which no best answer is known. The proposed study is designed to assist patient through this decision, by providing information and helping them to consider their values.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||168 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment Decision Making in Early-Stage Prostate Cancer: Evaluation of Computer Based Patient Education and an Interactive Decision Aid|
|Study Start Date :||September 2002|
|Actual Primary Completion Date :||December 2005|
|Actual Study Completion Date :||December 2005|
|Experimental: the Information + Decision Aid group||
Behavioral: CD-ROM-based prostate ca treatment education+decision tools
The goal of the present study was to explore men's use of a CD-ROM-based decision aid for early-stage PCa treatment decisions.
|Active Comparator: Information Only group||
Behavioral: CD-ROM-based prostate cancer treatment education
The goal was to explore men's use of a CD-ROM-based decision aid for early-stage PCa treatment decisions.
Other Name: Prostate Cancer Treatment Education
- treatment satisfaction, quality of life, prostate cancer knowledge at 1, 6, and 12 months post random assignment [ Time Frame: one, six, and one year follow-up assesments ]
- shared decision making at 1, 6, and 12 months post random assignment. [ Time Frame: one, six and one year follow-up assesments ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00196781
|United States, District of Columbia|
|Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20007|
|Principal Investigator:||Kathryn L. Taylor, Ph.D.||Georgetown University|