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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
13
CCOP - Carle Cancer Center
Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States
Change in pain assessed using the Brief Pain Inventory
Change in worst pain from baseline to day 15
Time frame: Assessed over 15 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center-Des Moines
Des Moines, Iowa, United States
Iowa Lutheran Hospital
Des Moines, Iowa, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Midlands Cancer Center at Midlands Community Hospital
Papillion, Nebraska, United States
CCOP - Northern New Jersey
Hackensack, New Jersey, United States
...and 8 more locations