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Group Therapy Compared With Educational Materials in Patients With Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gary Morrow, University of Rochester
ClinicalTrials.gov Identifier:
NCT00002848
First received: November 1, 1999
Last updated: March 4, 2013
Last verified: March 2013
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Rochester:

Estimated Enrollment: 480
Study Start Date: April 1997
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Detailed Description:

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

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002848

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
Sponsors and Collaborators
Gary Morrow
National Cancer Institute (NCI)
Investigators
Study Chair: Gary R. Morrow, PhD, MS James P. Wilmot Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Gary Morrow, Director, URCC CCOP Research Base, University of Rochester
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: March 4, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Rochester:
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
psychosocial effects of cancer and its treatment

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 21, 2013