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. Identifier: NCT00002848
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 5, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gary Morrow, University of Rochester

Brief Summary:

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 Phase
Prostate Cancer Psychosocial Effects of Cancer and Its Treatment Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Not Applicable

Detailed Description:


  • 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
Study Start Date : April 1997
Actual Primary Completion Date : September 2004
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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



  • Not specified

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • See Disease Characteristics


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified

Information from the National Library of Medicine

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

Responsible Party: Gary Morrow, Director, URCC CCOP Research Base, University of Rochester Identifier: NCT00002848     History of Changes
Other Study ID Numbers: CDR0000065087
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 5, 2013
Last Verified: March 2013

Keywords provided by Gary Morrow, 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
Genital Diseases, Male
Prostatic Diseases