Group Therapy Compared With Educational Materials in Patients With Prostate Cancer

Not Applicable

Completed

• Conditions: Prostate Cancer; Psychosocial Effects of Cancer and Its Treatment

• Registration Number: NCT00002848
• Lead Sponsor: Gary Morrow

Brief Summary

RATIONALE: Developing coping strategies may help improve the quality of life of patients with prostate cancer.

PURPOSE: This randomized clinical trial is comparing the effect of group therapy with written educational materials on the quality of life of men with stage I or stage II prostate cancer.

Detailed Description

OBJECTIVES:

* Determine the feasibility of providing group support, and evaluate the effect of supportive-expressive group therapy vs. written educational material on the psychological health and quality of life of men with stage I/II prostate cancer.

OUTLINE: Patients are stratified by prior hormonal therapy.

Patients continue standard oncologic treatment concurrently with supportive-expressive group therapy.

Supportive-expressive group therapy consists of twelve 90-minute weekly meetings with 8-12 members and 2 cotherapists and is based on the following themes: building bonds, expressing emotions, detoxifying dying, taking time to prioritize and set realistic goals, fortifying families, and dealing with doctors. Each session commences with a brief stress reduction exercise and ends with a brief cognitive restructuring imagery exercise. The main portion of the meeting emphasizes providing an environment in which patients can share their concerns, feelings, and thoughts openly and honestly. The role of the cotherapist is to facilitate expression of patients' concerns, offer empathy, and continue to encourage patients to express their feelings and thoughts.

Quality-of-life questionnaires are filled out at 3 and 6 months and then every 6 months for a total of 2 years.

PROJECTED ACCRUAL: Approximately 480 patients (including an estimated 53 minority patients) will be entered in this multicenter study.

Study Timeline

• Study Start: 1997-04
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2004-09
• Study Completion: 2004-09
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-04
• Last Update Posted: 2013-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 480

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (7)

James P. Wilmot Cancer Center at University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

CCOP - Northwest; 🇺🇸 Tacoma, Washington, United States

Stanford Cancer Center at Stanford University Medical Center; 🇺🇸 Stanford, California, United States

CCOP - Wichita; 🇺🇸 Wichita, Kansas, United States

CCOP - Western Regional, Arizona; 🇺🇸 Phoenix, Arizona, United States

CCOP - Kalamazoo; 🇺🇸 Kalamazoo, Michigan, United States

CCOP - Columbus; 🇺🇸 Columbus, Ohio, United States