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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002668
  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
Procedure: pain therapy
Procedure: psychosocial assessment and care

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer    Prostate Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, Randomized
Official Title:   PATIENT SKILLS FOR CANCER PAIN CONTROL IN PATIENTS WITH METASTATIC BREAST OR PROSTATE CANCER

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   96
Study Start Date:   October 1995

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
CCOP - MainLine Health    
      Wynnewood, Pennsylvania, United States, 19096
Penn State Cancer Institute at Milton S. Hershey Medical Center    
      Hershey, Pennsylvania, United States, 17033-0850
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
National Cancer Institute (NCI)

Investigators
Study Chair:     Charles Cleeland, PhD     M.D. Anderson Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000064257, ECOG-3Z93, NCI-P95-0068
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00002668
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer  
recurrent breast cancer  
stage IV prostate cancer  
recurrent prostate cancer  
pain  

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Skin Diseases
Breast Neoplasms
Urogenital Neoplasms
Pain
Genital Diseases, Male
Prostatic Neoplasms
Breast Diseases
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on September 16, 2008




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