Breast Cancer Clinical Trial
Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer
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.
Full 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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Recurrent or metastatic breast or prostate cancer
"Pain worst" score of 4 or greater on the Brief Pain Inventory
No prior enrollment on this study (patients treated during the run-in period are ineligible for randomization)
Hormone receptor status:
Not specified
PATIENT CHARACTERISTICS:
Age:
18 and over
Menopausal status:
Not specified
Performance status:
ECOG 0-2
Hematopoietic:
Not specified
Hepatic:
Not specified
Renal:
Not specified
Other:
No major psychiatric illness, including the following DSM-III-R diagnoses:
Bipolar disorder
Schizophrenia
Major depression
Multiple personality disorder
Psychotic disorder
Dementia
Outpatient status required
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Not specified
Chemotherapy:
Not specified
Endocrine therapy:
Not specified
Radiotherapy:
At least 28 days since prior palliative radiotherapy to major site(s) of pain
Surgery:
Greater than 30 days since prior surgery
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There are 17 Locations for this study
Urbana Illinois, 61801, United States
Cedar Rapids Iowa, 52403, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50316, United States
New Orleans Louisiana, 70121, United States
Saint Louis Park Minnesota, 55416, United States
Papillion Nebraska, 68128, United States
Hackensack New Jersey, 07601, United States
Albuquerque New Mexico, 87131, United States
Hershey Pennsylvania, 17033, United States
Wynnewood Pennsylvania, 19096, United States
Sioux Falls South Dakota, 57104, United States
Green Bay Wisconsin, 54307, United States
Westmead New South Wales, 2145, Australia
Lima , 34, Peru
San Juan , 00936, Puerto Rico
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