Completed

SUPPORTIVE-EXPRESSIVE GROUP THERAPY FOR MEN WITH PRIMARY PROSTATE CANCER

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What is being tested

psychosocial assessment and care

+ quality-of-life assessment

Procedure
Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

See all eligibility criteria
How is the trial designed

Interventional
Study Start: April 1997
See protocol details

Summary

Principal SponsorGary Morrow
Last updated: March 5, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 1997

Actual date on which the first participant was enrolled.

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.

NCT00002848
Principal SponsorGary Morrow
Last updated: March 5, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

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

480 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesUrogenital NeoplasmsMale Urogenital DiseasesProstatic Neoplasms

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

CCOP - Western Regional, Arizona

Phoenix, United StatesOpen CCOP - Western Regional, Arizona in Google Maps

Stanford Cancer Center at Stanford University Medical Center

Stanford, United States

CCOP - Wichita

Wichita, United States

CCOP - Kalamazoo

Kalamazoo, United States
Completed7 Study Centers