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Treatment Decision Intervention for Veterans with Prostate Cancer



Treatment Decision Intervention for Veterans with Prostate Cancer

For Condition: Prostate Cancer
Status: Completed
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Health Services Research and Development Service
Synopsis: Aims to provide an evaluation of the feasibility of decision analytic intervention. Long-range goal of the project is to design an intervention for veterans that increases both physician (MD) understanding of patient treatment preferences and patient understanding of choices in prostate cancer treatment. To improve the decision making process of veterans with localized prostate cancer by incorporating information on patient preferences, clinical characteristics, and therapeutic outcome probabilities into a decision analytic model that will produce individualized treatment recommendations for MDs and their patients to consider. Information about patient preferences for various potential health outcomes following treatment will be obtained using utility assessment methods that we have developed specifically for veterans. We have evaluated this utilities assessment approach in our ongoing six-VA hospital study. Utilities will be incorporated into a decision analytic model that has been developed by investigators at Memorial Sloan Kettering Cancer Center. This model estimates quality adjusted life year outcomes associated with alternative therapeutic options. Immediate aim: evaluate the effectiveness of providing MDs with information that incorporates the preferences of veterans with localized prostate cancer with the probabilities of treatment outcomes according to clinical prognostic indicators. Long-range objective: design an intervention for veterans that increases both MD understanding of patient treatment preferences and patient understanding of choices in treatment. We will compare the experimental group in which MDs are given a decision analytic derived treatment recommendation to the control group in which MDs are not given access to same. Primary aim: to examine the following hypotheses. At six months and one year post diagnosis, compared to the control group, the experimental group: 1) MDs will recommend therapies that are preferred based on the decision analytic model, especially when there is a large difference in anticipated life expectancy between the model-predicted best therapy and the second best therapeutic option; 2) MDs will less often recommend radical prostatectomy when the decision analytic model suggests that surgical treatment is associated with a large decrease in anticipated life expectancy in comparison to a model suggested non-surgical treatment option; 3) patients will have better prostate specific quality of life. We do not have specific hypotheses about patient perceived involvement in care, satisfaction with care, satisfaction with treatment decision, or decision regret. The intervention is delivered to the MD, not to the patient. Patients in both groups will complete utilities assessments, both will receive recommendations from their doctors, and both will complete quality of life and satisfaction questionnaires. Because of the similarities across the groups, the intervention may be experienced in the same way by both experimental and control patients. For this reason, there may be few differences between experimental and control patients in perceived involvement in care, satisfaction with care, satisfaction with decision, and decision regret. On the other hand, the experimental MDs may be more likely than control MDs to discuss the decision process with their patients. If this is the case, we would expect that experimental arm patients, as compared to control arm patients, would show greater perceived involvement in medical care, satisfaction with care, and satisfaction with treatment decision, and would be less likely to show decision regret. Secondary aim: to describe the factors influencing the treatment recommendations of MDs. We will accomplish this objective through qualitative interviews with experimental and control arm MDs. Plan: to interview the MDs of a subsample of patients selected randomly from among our participants. Goals in conducting physician interviews: 1) to identify the factors MDs perceive are influential in their treatment recommendations and 2) to identify ways in which MDs learn about patient preferences.
Details:
Eligibility:
Study Type:
  Interventional, Educational/Counseling/Training, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: VA male patients with a positive diagnosis of Prostate Cancer.
Total Enrollment: 100

Location and Contact Information:

VA Chicago Health Care System (Lakeside Division)
Chicago,  Illinois,  60611
United States
 

VA Chicago Health Care System (Lakeside Division)
Chicago,  Illinois,  60611
United States
 


Additional Information:
Study ID Numbers:
  PCI 99-159; 
Study Start Date: July 1999
Record last reviewed: October 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012935

Other Prostate Cancer Studies:
1. Comparison Study of MDX-010 (CTLA-4) Alone and Combined with Docetaxel in the Treatment of Patients with Hormone Refractory Prostate Cancer

2. Lycopene In Preventing of Prostate Cancer

3. Preoperative Thalidomide Followed By Radical Retropubic Prostatectomy In Select Patients With Locally Advanced Prostate Cancer

4. Phase I Study of Weekly Intravenous PS-341 Plus Mitoxantrone

5. A Safety and Feasibility Study of Active Immunotherapy in Patients with Metastatic Prostate Carcinoma Using Autologous Dendritic Cells Pulsed with Antigen Encoded in Amplified Autologous Tumor RNA

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