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

PURPOSE: Randomized clinical trial to study the effect of group therapy compared with written educational materials on the quality of life of men with stage I or stage II prostate cancer.

Condition	Treatment or Intervention
stage I prostate cancer stage II prostate cancer psychosocial effects/treatment Quality of Life	Procedure: psychosocial assessment/care  Procedure: quality-of-life assessment  Procedure: supportive care/therapy

Further Study Details: 

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.

Genders Eligible for Study:  Both

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

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

Arizona
      CCOP - Western Regional, Arizona, Phoenix,  Arizona,  85006-2726,  United States
California
      Stanford Cancer Center at Stanford University Medical Center, Stanford,  California,  94305-5718,  United States
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States
Michigan
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States
New York
      James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester,  New York,  14642,  United States
Ohio
      CCOP - Columbus, Columbus,  Ohio,  43206,  United States
Washington
      CCOP - Northwest, Tacoma,  Washington,  98405-0986,  United States

Study chairs or principal investigators

Gary R. Morrow, PhD, MS,  Study Chair,  James P. Wilmot Cancer Center   

Study ID Numbers:  CDR0000065087; URCC-U9994; NCI-CCC-94-32; URCC-9994P(A); NCI-P96-0072
Record last reviewed:  November 2004
Last Updated:  November 4, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002848
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08