Group Therapy Compared With Educational Materials in Patients With Prostate Cancer

March 4, 2013 updated by: Gary Morrow

SUPPORTIVE-EXPRESSIVE GROUP THERAPY FOR MEN WITH PRIMARY 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

480

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Arizona
  - Phoenix, Arizona, United States, 85006-2726
    - CCOP - Western Regional, Arizona
- California
  - Stanford, California, United States, 94305-5718
    - Stanford Cancer Center at Stanford University Medical Center
- Kansas
  - Wichita, Kansas, United States, 67214-3882
    - CCOP - Wichita
- Michigan
  - Kalamazoo, Michigan, United States, 49007-3731
    - CCOP - Kalamazoo
- New York
  - Rochester, New York, United States, 14642
    - James P. Wilmot Cancer Center at University of Rochester Medical Center
- Ohio
  - Columbus, Ohio, United States, 43206
    - CCOP - Columbus
- Washington
  - Tacoma, Washington, United States, 98405-0986
    - CCOP - Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gary Morrow

Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair: Gary R. Morrow, PhD, MS, James P. Wilmot Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1997

Primary Completion (Actual)

September 1, 2004

Study Completion (Actual)

September 1, 2004

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

March 5, 2013

Last Update Submitted That Met QC Criteria

March 4, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CDR0000065087
URCC-U9994
NCI-CCC-94-32
URCC-9994P(A)
NCI-P96-0072

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.