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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00002668
• Other study ID #: CDR0000064257
• Secondary ID: U10CA021115ECOG-
• Status: Terminated
• Phase: N/A
• Start date: February 14, 1996
• Est. completion date: September 1998

Study information

• Verified date: June 2023
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: September 1998
• Est. primary completion date: September 1998
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Pain
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Observation

• Educational Intervention and Behavioral Skills Training

Locations

Country	Name	City	State
Australia	Westmead Hospital	Westmead	New South Wales
Peru	Instituto de Enfermedades Neoplasicas	Lima
Puerto Rico	San Juan City Hospital	San Juan
United States	MBCCOP - University of New Mexico HSC	Albuquerque	New Mexico
United States	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	Iowa Lutheran Hospital	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	CCOP - St. Vincent Hospital Cancer Center, Green Bay	Green Bay	Wisconsin
United States	CCOP - Northern New Jersey	Hackensack	New Jersey
United States	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	CCOP - Ochsner	New Orleans	Louisiana
United States	Midlands Cancer Center at Midlands Community Hospital	Papillion	Nebraska
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	CCOP - MainLine Health	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,  Peru,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain assessed using the Brief Pain Inventory	Change in worst pain from baseline to day 15	Assessed over 15 days