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| Sponsor: | James P. Wilmot Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002848 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Prostate Cancer Psychosocial Effects of Cancer and Its Treatment |
Procedure: psychosocial assessment and care Procedure: quality-of-life assessment |
| Study Type: | Interventional |
| Official Title: | SUPPORTIVE-EXPRESSIVE GROUP THERAPY FOR MEN WITH PRIMARY PROSTATE CANCER |
| Estimated Enrollment: | 480 |
| Study Start Date: | April 1997 |
OBJECTIVES:
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.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| United States, Arizona | |
| CCOP - Western Regional, Arizona | |
| Phoenix, Arizona, United States, 85006-2726 | |
| United States, California | |
| Stanford Cancer Center at Stanford University Medical Center | |
| Stanford, California, United States, 94305-5718 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| United States, Michigan | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| United States, New York | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| United States, Ohio | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43206 | |
| United States, Washington | |
| CCOP - Northwest | |
| Tacoma, Washington, United States, 98405-0986 | |
| Study Chair: | Gary R. Morrow, PhD, MS | James P. Wilmot Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00002848 History of Changes |
| Other Study ID Numbers: | CDR0000065087, URCC-U9994, NCI-CCC-94-32, URCC-9994P(A), NCI-P96-0072 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 18, 2011 |
| Health Authority: | United States: Federal Government |
|
stage I prostate cancer stage IIB prostate cancer stage IIA prostate cancer psychosocial effects of cancer and its treatment |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |