Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer
- Conditions
- PainBreast CancerProstate Cancer
- Interventions
- Behavioral: Educational Intervention and Behavioral Skills TrainingBehavioral: Observation
- Registration Number
- NCT00002668
- Lead Sponsor
- Eastern Cooperative Oncology Group
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 13
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Educational Intervention and Behavioral Skills Training 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). Observation Observation Standard pain management interventions usually given by hospital staff
- Primary Outcome Measures
Name Time Method Change in pain assessed using the Brief Pain Inventory Assessed over 15 days Change in worst pain from baseline to day 15
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, 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
CCOP - Northern New Jersey
🇺🇸Hackensack, New Jersey, United States
Midlands Cancer Center at Midlands Community Hospital
🇺🇸Papillion, Nebraska, United States
MBCCOP - University of New Mexico HSC
🇺🇸Albuquerque, New Mexico, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
CCOP - MainLine Health
🇺🇸Wynnewood, Pennsylvania, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
🇺🇸Green Bay, Wisconsin, United States
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Instituto de Enfermedades Neoplasicas
🇵🇪Lima, Peru
San Juan City Hospital
🇵🇷San Juan, Puerto Rico
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States