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Home > "G" Clinical Trials Conditions > Group Therapy Compared With Educational Materials in Patients With Prostate Cancer  Group Therapy Compared With Educational Materials in Patients With Prostate Cancer
Group Therapy Compared With Educational Materials in Patients With Prostate Cancer
For Condition: stage 1 prostate cancer,stage 2 prostate cancer,psychosocial effects/treatment,Quality of Life
Status: Recruiting
Sponsor(s): James P. Wilmot Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GaryMorrow, Study Chair, James P. Wilmot Cancer Center
James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting Gary Morrow 585-275-5513
CCOP - Northwest *Recruiting*
Tacoma, Washington, 98405-0986
United States
Recruiting Lauren Colman 253-403-1677
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
Stanford Cancer Center at Stanford University Medical Center *Recruiting*
Stanford, California, 94305-5718
United States
Recruiting David Spiegel 650-723-6421
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 612-863-8585
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
CCOP - Western Regional, Arizona *Recruiting*
Phoenix, Arizona, 85006-2726
United States
Recruiting David King 602-258-4875
CCOP - Columbus *Recruiting*
Columbus, Ohio, 43206
United States
Recruiting J. Kuebler 614-488-2118
Additional Information:
Study ID Numbers: CDR0000065087; URCC-U9994,NCI-CCC-94-32,URCC-9994P(A),NCI-P96-0072
Study Start Date:
Record last reviewed: September 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002848
Other Stage 1 Prostate Cancer Studies:
1. Neoadjuvant CCI-779 Followed By Radical Prostatectomy in Treating Patients With Newly Diagnosed Prostate Cancer Who Have a High Risk of Relapse
2. Celecoxib Compared With No Treatment Before Surgery in Treating Patients With Localized Prostate Cancer
3. Group Therapy Compared With Educational Materials in Patients With Prostate Cancer
4. Ultrasound in Treating Patients With Recurrent Stage I or Stage II Prostate Cancer
5. Calcitriol and Zoledronate in Treating Patients With Progressive Prostate Cancer
Related Studies:
Other stage 1 prostate cancer Clinical Trials
Other Kansas Clinical Trials
Other Wichita Clinical Trials
Group Therapy Compared With Educational Materials in Patients With Prostate Cancer
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