Group Therapy Compared With Educational Materials in Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

SUPPORTIVE-EXPRESSIVE GROUP THERAPY FOR MEN WITH PRIMARY PROSTATE CANCER

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002848
• Other study ID #: CDR0000065087
• Secondary ID: URCC-U9994NCI-CC
• Status: Completed
• Phase: N/A
• First received: November 1, 1999
• Last updated: March 4, 2013
• Start date: April 1997
• Est. completion date: September 2004

Study information

• Verified date: March 2013
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: September 2004
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Psychosocial Effects of Cancer and Its Treatment

Intervention

Procedure:
• psychosocial assessment and care

• quality-of-life assessment

Locations

Country	Name	City	State
United States	CCOP - Columbus	Columbus	Ohio
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	CCOP - Western Regional, Arizona	Phoenix	Arizona
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York
United States	Stanford Cancer Center at Stanford University Medical Center	Stanford	California
United States	CCOP - Northwest	Tacoma	Washington
United States	CCOP - Wichita	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Gary Morrow	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,