Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Group Therapy Compared With Educational Materials in Patients With Prostate Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Educational/Counseling/Training Closed no age specified NCI URCC-U9994 NCI-CCC-94-32, URCC-9994P(A), NCI-P96-0072, NCT00002848

Objectives

1. 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.

Entry Criteria

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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

James P. Wilmot Cancer Center at University of Rochester Medical Center

Gary Morrow, PhD, MS, Protocol chair		Ph: 585-275-5513

Registry Information
Official Title		SUPPORTIVE-EXPRESSIVE GROUP THERAPY FOR MEN WITH PRIMARY PROSTATE CANCER
Trial Start Date		1997-04-16
Registered in ClinicalTrials.gov		NCT00002848
Date Submitted to PDQ		1996-09-18
Information Last Verified		2004-07-16

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