NCT Number: NCT00002848
Group Therapy Compared With Educational Materials in Patients With Prostate Cancer
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.
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Notify MeKey information
Conditions
Sex eligibility
Male
Study type
Interventional
Phase
Not applicable
Primary location
CCOP - Western Regional, Arizona, Phoenix, Arizona, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
quality-of-life assessment
ProcedureSponsors and collaborators
Lead sponsor
Gary Morrow
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
SUPPORTIVE-EXPRESSIVE GROUP THERAPY FOR MEN WITH PRIMARY PROSTATE CANCER
Important dates
- Study start
- 1997
- Primary completion
- 2004
- Study completion
- 2004
- First posted
- Jan 27, 2003
- Registry last updated
- Mar 5, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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