Slow accrual

RATIONALE: An outpatient educational and behavioral skills training program may help patients with metastatic breast or prostate cancer live longer and more comfortably.

PURPOSE: This randomized clinical trial studies whether an outpatient educational and behavioral skills training program will improve pain control in patients who have metastatic or recurrent 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.

DISEASE CHARACTERISTICS:

• Recurrent or metastatic breast or prostate cancer

• "Pain worst" score of 4 or greater on the Brief Pain Inventory

• No prior enrollment on this study (patients treated during the run-in period are ineligible for randomization)

• Hormone receptor status:

  • Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Menopausal status:

• Not specified

Performance status:

• ECOG 0-2

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No major psychiatric illness, including the following DSM-III-R diagnoses:

  • Bipolar disorder
  • Schizophrenia
  • Major depression
  • Multiple personality disorder
  • Psychotic disorder
  • Dementia
  • Outpatient status required

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 28 days since prior palliative radiotherapy to major site(s) of pain

Surgery:

• Greater than 30 days since prior surgery