Treatment Decision Intervention for Veterans With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Treatment Decision Intervention for Veterans With Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00012935
• Other study ID #: PCI 99-159
• Status: Completed
• Phase: N/A
• First received: March 14, 2001
• Last updated: April 6, 2015
• Est. completion date: December 2001

Study information

• Verified date: February 2007
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2001
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

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:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Help with decision making on prostate cancer treatment

Locations

Country	Name	City	State
United States	Jesse Brown VA Medical Center Community-Based Outpatient Clinic Lake Side Divison, Chicago, IL	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation