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

June 20, 2023 updated by: Eastern Cooperative Oncology Group

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
  • Peru
      • Lima, Peru, 34
        • Instituto De Enfermedades Neoplasicas
  • Puerto Rico
      • San Juan, Puerto Rico, 00936-7344
        • San Juan City Hospital
  • United States
    • Illinois
      • Urbana, Illinois, United States, 61801
        • CCOP - Carle Cancer Center
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403-1206
        • CCOP - Cedar Rapids Oncology Project
      • Des Moines, Iowa, United States, 50309
        • John Stoddard Cancer Center at Iowa Methodist Medical Center
      • Des Moines, Iowa, United States, 50309-1016
        • CCOP - Iowa Oncology Research Association
      • Des Moines, Iowa, United States, 50316-2301
        • Iowa Lutheran Hospital
      • Des Moines, Iowa, United States, 50314
        • Mercy Cancer Center at Mercy Medical Center-Des Moines
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • CCOP - Ochsner
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • CCOP - Metro-Minnesota
    • Nebraska
      • Papillion, Nebraska, United States, 68128-4157
        • Midlands Cancer Center at Midlands Community Hospital
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • CCOP - Northern New Jersey
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • MBCCOP - University of New Mexico HSC
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Wynnewood, Pennsylvania, United States, 19096
        • CCOP - MainLine Health
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • CCOP - Sioux Community Cancer Consortium
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54307-3453
        • CCOP - St. Vincent Hospital Cancer Center, Green Bay

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Observation
Standard pain management interventions usually given by hospital staff
Behavioral: Observation
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Cooperative Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Charles Cleeland, PhD, M.D. Anderson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 1996

Primary Completion (Actual)

September 1, 1998

Study Completion (Actual)

September 1, 1998

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimated)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000064257
  • U10CA021115 (U.S. NIH Grant/Contract)
  • ECOG-3Z93
  • NCI-P95-0068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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