Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer
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.
Behavioral: Educational Intervention and Behavioral Skills Training
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||PATIENT SKILLS FOR CANCER PAIN CONTROL IN PATIENTS WITH METASTATIC BREAST OR PROSTATE CANCER|
- Change in pain assessed using the Brief Pain Inventory [ Time Frame: Assessed over 15 days ] [ Designated as safety issue: No ]Change in worst pain from baseline to day 15
|Study Start Date:||October 1995|
|Study Completion Date:||September 1998|
|Primary Completion Date:||September 1998 (Final data collection date for primary outcome measure)|
Active Comparator: Observation
Standard pain management interventions usually given by hospital staff
Experimental: Educational Intervention and Behavioral Skills Training
Patients participated in a program including video presentations, written materials, and coaching in behavioral skills to improve pain control (not to reduce analgesic use).
|Behavioral: Educational Intervention and Behavioral Skills Training|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002668
|United States, Illinois|
|CCOP - Carle Cancer Center|
|Urbana, Illinois, United States, 61801|
|United States, Iowa|
|CCOP - Cedar Rapids Oncology Project|
|Cedar Rapids, Iowa, United States, 52403-1206|
|Mercy Cancer Center at Mercy Medical Center-Des Moines|
|Des Moines, Iowa, United States, 50314|
|CCOP - Iowa Oncology Research Association|
|Des Moines, Iowa, United States, 50309-1016|
|John Stoddard Cancer Center at Iowa Methodist Medical Center|
|Des Moines, Iowa, United States, 50309|
|Iowa Lutheran Hospital|
|Des Moines, Iowa, United States, 50316-2301|
|United States, Louisiana|
|CCOP - Ochsner|
|New Orleans, Louisiana, United States, 70121|
|United States, Minnesota|
|CCOP - Metro-Minnesota|
|Saint Louis Park, Minnesota, United States, 55416|
|United States, Nebraska|
|Midlands Cancer Center at Midlands Community Hospital|
|Papillion, Nebraska, United States, 68128-4157|
|United States, New Jersey|
|CCOP - Northern New Jersey|
|Hackensack, New Jersey, United States, 07601|
|United States, New Mexico|
|MBCCOP - University of New Mexico HSC|
|Albuquerque, New Mexico, United States, 87131|
|United States, Pennsylvania|
|Penn State Cancer Institute at Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033-0850|
|CCOP - MainLine Health|
|Wynnewood, Pennsylvania, United States, 19096|
|United States, South Dakota|
|CCOP - Sioux Community Cancer Consortium|
|Sioux Falls, South Dakota, United States, 57104|
|United States, Wisconsin|
|CCOP - St. Vincent Hospital Cancer Center, Green Bay|
|Green Bay, Wisconsin, United States, 54307-3453|
|Australia, New South Wales|
|Westmead, New South Wales, Australia, 2145|
|Instituto de Enfermedades Neoplasicas|
|Lima, Peru, 34|
|San Juan City Hospital|
|San Juan, Puerto Rico, 00936-7344|
|Study Chair:||Charles Cleeland, PhD||M.D. Anderson Cancer Center|