Group Therapy Compared With Educational Materials in Patients With Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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SUPPORTIVE-EXPRESSIVE GROUP THERAPY FOR MEN WITH PRIMARY PROSTATE CANCER

Conditions
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Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment

Intervention / Treatment
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* Procedure: psychosocial assessment and care
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Biopsy-proven prostate cancer diagnosed within 1 year prior to entry Clinical stage I/II (T1b-c or T2, N0 or Nx, M0) disease Pathologic local upstaging (e.g., to T3) allowed No Nx disease if pathologic or partial pathologic (e.g., lymph node biopsy or dissection) staging performed No major psychiatric illness requiring hospitalization or medication other than depression or anxiety for less than 1 year No second malignancy within 10 years except nonmelanomatous skin cancer Clinical follow-up by a urologist, medical oncologist, or radiation therapist required at least semi-annually PATIENT CHARACTERISTICS: Age Not specified Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other See Disease Characteristics PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: psychosocial assessment and care|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, psychosocial effects of cancer and its treatment