Group Therapy Compared With Educational Materials in Patients With Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00002848|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 5, 2013
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 or disease||Intervention/treatment|
|Prostate Cancer Psychosocial Effects of Cancer and Its Treatment||Procedure: psychosocial assessment and care Procedure: quality-of-life assessment|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||480 participants|
|Official Title:||SUPPORTIVE-EXPRESSIVE GROUP THERAPY FOR MEN WITH PRIMARY PROSTATE CANCER|
|Study Start Date :||April 1997|
|Primary Completion Date :||September 2004|
|Study Completion Date :||September 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002848
|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|