Group Therapy Compared With Educational Materials in Patients With Prostate Cancer
NCT ID: NCT00002848
Last Updated: 2013-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
480 participants
INTERVENTIONAL
1997-04-30
2004-09-30
Brief Summary
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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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Detailed Description
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* 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.
Conditions
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Interventions
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psychosocial assessment and care
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* 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
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gary Morrow
OTHER
Responsible Party
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Gary Morrow
Director, URCC CCOP Research Base
Principal Investigators
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Gary R. Morrow, PhD, MS
Role: STUDY_CHAIR
James P. Wilmot Cancer Center
Locations
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CCOP - Western Regional, Arizona
Phoenix, Arizona, United States
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States
CCOP - Wichita
Wichita, Kansas, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
CCOP - Columbus
Columbus, Ohio, United States
CCOP - Northwest
Tacoma, Washington, United States
Countries
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Other Identifiers
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URCC-U9994
Identifier Type: -
Identifier Source: secondary_id
NCI-CCC-94-32
Identifier Type: -
Identifier Source: secondary_id
URCC-9994P(A)
Identifier Type: -
Identifier Source: secondary_id
NCI-P96-0072
Identifier Type: -
Identifier Source: secondary_id
CDR0000065087
Identifier Type: -
Identifier Source: org_study_id
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