Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Eastern Cooperative Oncology Group

Charles Cleeland

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00002668
Information obtained from ClinicalTrials.gov on December 14, 2011

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