Trial Information

PATIENT SKILLS FOR CANCER PAIN CONTROL IN PATIENTS WITH METASTATIC BREAST OR PROSTATE CANCER

OBJECTIVES:

- Evaluate the feasibility of implementing an outpatient education and behavioral skills
training program for pain control in a multi-institution setting.

- Evaluate whether patient education and behavioral skills training improve cancer pain
control in patients with recurrent or metastatic breast or prostate cancer.

- Amend the protocol, with the approval of the Division of Cancer Prevention and Control,
to a groupwide 3-arm study if analysis demonstrates feasibility and potential efficacy
of the patient education and behavioral skills training program.

OUTLINE: This is a randomized study. Patients are stratified according to diagnosis (breast
vs prostate cancer), initial "pain worst" score (4-6 vs 7 or higher), and participating
institution. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive standard pain management.

- Arm II: Patients receive educational intervention (booklets, audiotapes, and
videotapes) and behavioral skills training (including a schedule of practice relaxation
sessions) in addition to standard pain management. Patients receive a follow-up phone
call within 48-72 hours of intervention to review pain status.

Patients on both arms undergo pain and psychological assessments on days 1 and 15.

PROJECTED ACCRUAL: A total of 96 patients (48 per arm) will be accrued for this study.