Breast Cancer, Pain, Prostate Cancer
Conditions
Keywords
stage IV breast cancer, recurrent breast cancer, stage IV prostate cancer, recurrent prostate cancer, pain
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALObservation
BEHAVIORALEducational Intervention and Behavioral Skills Training
Sponsors
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain assessed using the Brief Pain Inventory | Assessed over 15 days | Change in worst pain from baseline to day 15 |
Countries
Australia, Peru, Puerto Rico, United States
Outcome results
None listed