Group Therapy Compared With Educational Materials in Patients With Prostate Cancer

SUPPORTIVE-EXPRESSIVE GROUP THERAPY FOR MEN WITH PRIMARY PROSTATE CANCER

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002848

Enrollment

480

Registered

2003-01-27

Start date

1997-04-30

Completion date

2004-09-30

Last updated

2013-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment

Keywords

stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, psychosocial effects of cancer and its treatment

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.

Interventions

PROCEDUREpsychosocial assessment and care

PROCEDUREquality-of-life assessment

Eligibility

Sex/Gender

MALE

Healthy volunteers

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026