Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Department of Veterans Affairs |
---|---|
Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00012935 |
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.
Condition | Intervention |
---|---|
Prostate Cancer |
Behavioral: Help with decision making on prostate cancer treatment |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Treatment Decision Intervention for Veterans With Prostate Cancer |
Estimated Enrollment: | 100 |
Study Completion Date: | December 2001 |
Arms | Assigned Interventions |
---|---|
1 | Behavioral: Help with decision making on prostate cancer treatment |
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
Ages Eligible for Study: | 50 Years to 80 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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:
United States, California | |
VA Medical Center | |
San Francisco, California, United States, 94121 | |
United States, Illinois | |
Jesse Brown VAMC (Lakeside CBOC) | |
Chicago, Illinois, United States, 60611 |
Principal Investigator: | Charles L. Bennett, MD PhD MPP | Jesse Brown VAMC (Lakeside CBOC) |
Responsible Party: | Department of Veterans Affairs ( Bennett, Charles - Principal Investigator ) |
Study ID Numbers: | PCI 99-159 |
Study First Received: | March 14, 2001 |
Last Updated: | October 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00012935 History of Changes |
Health Authority: | United States: Federal Government |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |