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Tracking Information | |||||
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First Received Date † | March 14, 2001 | ||||
Last Updated Date | October 31, 2008 | ||||
Start Date † | |||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | Complete list of historical versions of study NCT00012935 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Treatment Decision Intervention for Veterans With Prostate Cancer | ||||
Official Title † | Treatment Decision Intervention for Veterans With Prostate Cancer | ||||
Brief Summary | Newly diagnosed localized prostate cancer patients face difficult decisions about treatment and management; including radiation therapy, radical prostatectomy, brachytherapy, and observation. Previous studies have cited patient preference and physician recommendation for treatment as major roles in treatment decisions. |
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Detailed Description | Background: Newly diagnosed localized prostate cancer patients face difficult decisions about treatment and management; including radiation therapy, radical prostatectomy, brachytherapy, and observation. Previous studies have cited patient preference and physician recommendation for treatment as major roles in treatment decisions. Objectives: This grant will be used to develop and evaluate a decision analysis based intervention to improve decision-making among veterans with newly diagnosed localized prostate cancer. While the ultimate goal of this study is to improve decision-making among these patients, factors influencing physician recommendations for treatment will be sought. The former will be achieved by evaluating the efficacy of providing physicians with information incorporating patient preference for alternative health states with probabilities of treatment outcomes. Factors influencing physician recommendations for treatment will be determined through qualitative interviews with physicians. Methods: Patients were accrued at the VA Chicago Health Care System Lakeside Urology Clinic. Upon consent for participation in the study, comorbidities, histologic grade of the biopsy, and age were obtained for 13 patients with newly diagnosed localized prostate cancer. Using a standard gamble technique, interviewers obtained patient utilities for 5 distinct health states related to prostate cancer treatment. Clinical and pathologic characteristics were incorporated into the decision analytic model, and the derived quality-adjusted life expectancies (QALEs) were shared with the treating urologist before patient-physician discussion of treatment options. The feasibility of the decision analytic intervention and unbiased estimates of the impact of the intervention was evaluated. The long-range objective of this proposal is to design an intervention for veterans that increases physician understanding of patient treatment preferences and patient understanding of choices in prostate cancer treatment. Status: Completed |
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Study Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Other, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||
Condition † | Prostate Cancer | ||||
Intervention † | Behavioral: Help with decision making on prostate cancer treatment | ||||
Study Arms / Comparison Groups | |||||
Publications * | Knight SJ, Nathan DP, Siston AK, Kattan MW, Elstein AS, Collela KM, Wolf MS, Slimack NS, Bennett CL, Golub RM. Pilot study of a utilities-based treatment decision intervention for prostate cancer patients. Clin Prostate Cancer. 2002 Sep;1(2):105-14. | ||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 100 | ||||
Completion Date | December 2001 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria: 1) biopsy confirmed diagnosis of localized prostate cancer; 2) newly diagnosed-no prior treatment (including watchful waiting) or discussion with their prior physicians about treatment options; 3) no previous neoplasms in the last five years, with the exception of basal cell cancer of the skin; 4) speak english; 5) no major psychiatric disorder that would preclude their participation; 6) be between 50 and 80 years of age. Exclusion Criteria: |
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Gender | Male | ||||
Ages | 50 Years to 80 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00012935 | ||||
Responsible Party | Bennett, Charles - Principal Investigator, Department of Veterans Affairs | ||||
Secondary IDs †† | |||||
Study Sponsor † | Department of Veterans Affairs | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Department of Veterans Affairs | ||||
Verification Date | January 2005 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |