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

Not Applicable

Terminated

• Conditions: Pain; Breast Cancer; Prostate Cancer

• 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.

Study Timeline

• Study Start: 1996-02-14
• Primary Completion: 1998-09
• Study Completion: 1998-09
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-20
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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

Trial Locations

Locations (18)

CCOP - Carle Cancer Center; 🇺🇸 Urbana, Illinois, United States

CCOP - Cedar Rapids Oncology Project; 🇺🇸 Cedar Rapids, Iowa, United States

CCOP - Iowa Oncology Research Association; 🇺🇸 Des Moines, 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

Midlands Cancer Center at Midlands Community Hospital; 🇺🇸 Papillion, Nebraska, United States

CCOP - Northern New Jersey; 🇺🇸 Hackensack, New Jersey, United States

Scroll for more (8 remaining)