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OpenTrials
Completed

NCT Number: NCT00002848

Group Therapy Compared With Educational Materials in Patients With 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.

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Key information

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

CCOP - Western Regional, Arizona, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

psychosocial assessment and care

Procedure

quality-of-life assessment

Procedure

Sponsors and collaborators

Lead sponsor

Gary Morrow

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

SUPPORTIVE-EXPRESSIVE GROUP THERAPY FOR MEN WITH PRIMARY PROSTATE CANCER

Important dates

Study start
1997
Primary completion
2004
Study completion
2004
First posted
Jan 27, 2003
Registry last updated
Mar 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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