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Group Therapy Compared With Educational Materials in Patients With Prostate Cancer

Primary Purpose

Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
psychosocial assessment and care
quality-of-life assessment
Sponsored by
Gary Morrow
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Prostate Cancer focused on measuring stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, psychosocial effects of cancer and its treatment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • CCOP - Western Regional, Arizona
  • Stanford Cancer Center at Stanford University Medical Center
  • CCOP - Wichita
  • CCOP - Kalamazoo
  • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • CCOP - Columbus
  • CCOP - Northwest

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
March 4, 2013
Sponsor
Gary Morrow
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00002848
Brief Title
Group Therapy Compared With Educational Materials in Patients With Prostate Cancer
Official Title
SUPPORTIVE-EXPRESSIVE GROUP THERAPY FOR MEN WITH PRIMARY PROSTATE CANCER
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
April 1997 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
September 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gary Morrow
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment
Keywords
stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, psychosocial effects of cancer and its treatment

7. Study Design

Study Phase
Not Applicable
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
psychosocial assessment and care
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary R. Morrow, PhD, MS
Organizational Affiliation
James P. Wilmot Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Western Regional, Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006-2726
Country
United States
Facility Name
Stanford Cancer Center at Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5718
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43206
Country
United States
Facility Name
CCOP - Northwest
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405-0986
Country
United States

12. IPD Sharing Statement

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Group Therapy Compared With Educational Materials in Patients With Prostate Cancer

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