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

Primary Purpose

Breast Cancer, Pain, Prostate Cancer

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Observation
Educational Intervention and Behavioral Skills Training
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring stage IV breast cancer, recurrent breast cancer, stage IV prostate cancer, recurrent prostate cancer, pain

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CCOP - Carle Cancer Center
  • CCOP - Cedar Rapids Oncology Project
  • CCOP - Iowa Oncology Research Association
  • John Stoddard Cancer Center at Iowa Methodist Medical Center
  • Mercy Cancer Center at Mercy Medical Center-Des Moines
  • Iowa Lutheran Hospital
  • CCOP - Ochsner
  • CCOP - Metro-Minnesota
  • Midlands Cancer Center at Midlands Community Hospital
  • CCOP - Northern New Jersey
  • MBCCOP - University of New Mexico HSC
  • Penn State Cancer Institute at Milton S. Hershey Medical Center
  • CCOP - MainLine Health
  • CCOP - Sioux Community Cancer Consortium
  • CCOP - St. Vincent Hospital Cancer Center, Green Bay
  • Westmead Hospital
  • Instituto de Enfermedades Neoplasicas
  • San Juan City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Observation

Educational Intervention and Behavioral Skills Training

Arm Description

Standard pain management interventions usually given by hospital staff

Patients participated in a program including video presentations, written materials, and coaching in behavioral skills to improve pain control (not to reduce analgesic use).

Outcomes

Primary Outcome Measures

Change in pain assessed using the Brief Pain Inventory
Change in worst pain from baseline to day 15

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 20, 2023
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00002668
Brief Title
Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer
Official Title
PATIENT SKILLS FOR CANCER PAIN CONTROL IN PATIENTS WITH METASTATIC BREAST OR PROSTATE CANCER
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
February 14, 1996 (Actual)
Primary Completion Date
September 1998 (Actual)
Study Completion Date
September 1998 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Pain, Prostate Cancer
Keywords
stage IV breast cancer, recurrent breast cancer, stage IV prostate cancer, recurrent prostate cancer, pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Observation
Arm Type
Active Comparator
Arm Description
Standard pain management interventions usually given by hospital staff
Arm Title
Educational Intervention and Behavioral Skills Training
Arm Type
Experimental
Arm Description
Patients participated in a program including video presentations, written materials, and coaching in behavioral skills to improve pain control (not to reduce analgesic use).
Intervention Type
Behavioral
Intervention Name(s)
Observation
Intervention Type
Behavioral
Intervention Name(s)
Educational Intervention and Behavioral Skills Training
Primary Outcome Measure Information:
Title
Change in pain assessed using the Brief Pain Inventory
Description
Change in worst pain from baseline to day 15
Time Frame
Assessed over 15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Cleeland, PhD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
CCOP - Cedar Rapids Oncology Project
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403-1206
Country
United States
Facility Name
CCOP - Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309-1016
Country
United States
Facility Name
John Stoddard Cancer Center at Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Mercy Cancer Center at Mercy Medical Center-Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Iowa Lutheran Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50316-2301
Country
United States
Facility Name
CCOP - Ochsner
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Midlands Cancer Center at Midlands Community Hospital
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68128-4157
Country
United States
Facility Name
CCOP - Northern New Jersey
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
MBCCOP - University of New Mexico HSC
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Penn State Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
CCOP - MainLine Health
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
CCOP - Sioux Community Cancer Consortium
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
CCOP - St. Vincent Hospital Cancer Center, Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54307-3453
Country
United States
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Instituto de Enfermedades Neoplasicas
City
Lima
ZIP/Postal Code
34
Country
Peru
Facility Name
San Juan City Hospital
City
San Juan
ZIP/Postal Code
00936-7344
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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