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Clinical Trials/NCT00012935
NCT00012935
Completed
Not Applicable

Treatment Decision Intervention for Veterans With Prostate Cancer

US Department of Veterans Affairs1 site in 1 country100 target enrollmentMarch 16, 2001
ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
US Department of Veterans Affairs
Enrollment
100
Locations
1
Status
Completed
Last Updated
11 years ago

Overview

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.

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

Registry
clinicaltrials.gov
Start Date
March 16, 2001
End Date
December 2001
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

  • Not provided

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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