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

This study has been terminated.
(Slow accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00002668
First received: November 1, 1999
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Breast Cancer
Pain
Prostate Cancer
Behavioral: Observation
Behavioral: Educational Intervention and Behavioral Skills Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: PATIENT SKILLS FOR CANCER PAIN CONTROL IN PATIENTS WITH METASTATIC BREAST OR PROSTATE CANCER

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • Change in pain assessed using the Brief Pain Inventory [ Time Frame: Assessed over 15 days ] [ Designated as safety issue: No ]
    Change in worst pain from baseline to day 15


Enrollment: 13
Study Start Date: October 1995
Study Completion Date: September 1998
Primary Completion Date: September 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002668

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

Additional Information:
No publications provided

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00002668     History of Changes
Other Study ID Numbers: CDR0000064257, U10CA021115, ECOG-3Z93, NCI-P95-0068
Study First Received: November 1, 1999
Last Updated: November 30, 2012
Health Authority: United States: Federal Government

Keywords provided by Eastern Cooperative Oncology Group:
stage IV breast cancer
recurrent breast cancer
stage IV prostate cancer
recurrent prostate cancer
pain

Additional relevant MeSH terms:
Breast Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014