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

NCT00002668 | Terminated

• 4 other identifiers: CDR0000064257U10CA021115ECOG-3Z93NCI-P95-0068
• Study Type: interventional
• Target: 13
• Locations: 4 countries
• Sites: 18

Brief 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.

Conditions

Breast Cancer; Pain; Prostate Cancer

Keywords

stage IV breast cancer; recurrent breast cancer; stage IV prostate cancer; recurrent prostate cancer; pain

Outcome Measures

Primary Outcomes (1)

• Change in pain assessed using the Brief Pain Inventory

  Change in worst pain from baseline to day 15

  Assessed over 15 days

Study Arms (2)

Observation

ACTIVE COMPARATOR

Standard pain management interventions usually given by hospital staff

Behavioral: Observation

Educational Intervention and Behavioral Skills Training

EXPERIMENTAL

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

Interventions

Observation BEHAVIORAL

Observation

Educational Intervention and Behavioral Skills Training BEHAVIORAL

Educational Intervention and Behavioral Skills Training

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (18)

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

John Stoddard Cancer Center at Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Mercy Cancer Center at Mercy Medical Center-Des Moines

Des Moines, Iowa, 50314, United States

Location

Iowa Lutheran Hospital

Des Moines, Iowa, 50316-2301, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Midlands Cancer Center at Midlands Community Hospital

Papillion, Nebraska, 68128-4157, United States

Location

CCOP - Northern New Jersey

Hackensack, New Jersey, 07601, United States

Location

MBCCOP - University of New Mexico HSC

Albuquerque, New Mexico, 87131, United States

Location

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

CCOP - MainLine Health

Wynnewood, Pennsylvania, 19096, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54307-3453, United States

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Instituto de Enfermedades Neoplasicas

Lima, 34, Peru

Location

San Juan City Hospital

San Juan, 00936-7344, Puerto Rico

Location

MeSH Terms

Conditions

Breast Neoplasms; Pain; Prostatic Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Charles Cleeland, PhD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: February 14, 1996
• Primary Completion: September 1, 1998
• Study Completion: September 1, 1998
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

PR (1); US (15); AU (1); PE (1)