Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00002668|
Recruitment Status : Terminated (Slow accrual)
First Posted : January 27, 2003
Last Update Posted : December 3, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Pain Prostate Cancer||Behavioral: Observation Behavioral: Educational Intervention and Behavioral Skills Training||Not Applicable|
- 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 (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||PATIENT SKILLS FOR CANCER PAIN CONTROL IN PATIENTS WITH METASTATIC BREAST OR PROSTATE CANCER|
|Study Start Date :||October 1995|
|Actual Primary Completion Date :||September 1998|
|Actual Study Completion Date :||September 1998|
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
- Change in pain assessed using the Brief Pain Inventory [ Time Frame: Assessed over 15 days ]Change in worst pain from baseline to day 15
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|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|
|Mercy Cancer Center at Mercy Medical Center-Des Moines|
|Des Moines, Iowa, United States, 50314|
|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|