Group Therapy Compared With Educational Materials in Patients With Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
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

November 1, 1999
March 4, 2013
April 1997
September 2004   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00002848 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Group Therapy Compared With Educational Materials in Patients With Prostate Cancer
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.

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.

Interventional
Not Provided
Not Provided
  • Prostate Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • Procedure: psychosocial assessment and care
  • Procedure: quality-of-life assessment
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
480
September 2004
September 2004   (final data collection date for primary outcome measure)

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
Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002848
CDR0000065087, URCC-U9994, NCI-CCC-94-32, URCC-9994P(A), NCI-P96-0072
No
Gary Morrow, University of Rochester
Gary Morrow
National Cancer Institute (NCI)
Study Chair: Gary R. Morrow, PhD, MS James P. Wilmot Cancer Center
University of Rochester
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP