Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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PATIENT SKILLS FOR CANCER PAIN CONTROL IN PATIENTS WITH METASTATIC BREAST OR PROSTATE CANCER

Conditions
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Breast Cancer, Pain, Prostate Cancer

Intervention / Treatment
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* Behavioral: Observation
* Behavioral: Educational Intervention and Behavioral Skills Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Observation<br>Standard pain management interventions usually given by hospital staff | Behavioral: Observation<br> <br> |
| Experimental: Educational Intervention and Behavioral Skills Training<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain assessed using the Brief Pain Inventory | Change in worst pain from baseline to day 15 | Assessed over 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, stage IV breast cancer, recurrent breast cancer, stage IV prostate cancer, recurrent prostate cancer