PATIENT SKILLS FOR CANCER PAIN CONTROL IN PATIENTS WITH METASTATIC BREAST OR PROSTATE CANCER
- 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Change in pain assessed using the Brief Pain Inventory
Change in worst pain from baseline to day 15
Assessed over 15 days
Charles Cleeland, PhD
M.D. Anderson Cancer Center
United States: Federal Government
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|CCOP - Iowa Oncology Research Association||Des Moines, Iowa 50309-1016|
|CCOP - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|CCOP - Northern New Jersey||Hackensack, New Jersey 07601|
|Penn State Cancer Institute at Milton S. Hershey Medical Center||Hershey, Pennsylvania 17033-0850|
|CCOP - Cedar Rapids Oncology Project||Cedar Rapids, Iowa 52403-1206|
|CCOP - Ochsner||New Orleans, Louisiana 70121|
|CCOP - Sioux Community Cancer Consortium||Sioux Falls, South Dakota 57105-1080|
|CCOP - MainLine Health||Wynnewood, Pennsylvania 19096|
|MBCCOP - University of New Mexico HSC||Albuquerque, New Mexico 87131|
|CCOP - St. Vincent Hospital Cancer Center, Green Bay||Green Bay, Wisconsin 54301|
|Iowa Lutheran Hospital||Des Moines, Iowa 50316-2301|
|John Stoddard Cancer Center at Iowa Methodist Medical Center||Des Moines, Iowa 50309|
|Mercy Cancer Center at Mercy Medical Center-Des Moines||Des Moines, Iowa 50314|
|Midlands Cancer Center at Midlands Community Hospital||Papillion, Nebraska 68128-4157|