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Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer
This study is ongoing, but not recruiting participants.
Study NCT00002668   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes

November 1, 1999
February 6, 2009
October 1995
 
 
 
Complete list of historical versions of study NCT00002668 on ClinicalTrials.gov Archive Site
 
 
 
Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer
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.

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.

 
Interventional
Other, Randomized
  • Breast Cancer
  • Pain
  • Prostate Cancer
  • Procedure: pain therapy
  • Procedure: psychosocial assessment and care
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
96
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Peru,   Puerto Rico
 
NCT00002668
 
CDR0000064257, ECOG-3Z93, NCI-P95-0068
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Charles Cleeland, PhD M.D. Anderson Cancer Center
National Cancer Institute (NCI)
September 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP