Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer
NCT ID: NCT00002668
Last Updated: 2023-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
13 participants
INTERVENTIONAL
1996-02-14
1998-09-30
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Observation
Standard pain management interventions usually given by hospital staff
Observation
Educational Intervention and Behavioral Skills Training
Patients participated in a program including video presentations, written materials, and coaching in behavioral skills to improve pain control (not to reduce analgesic use).
Educational Intervention and Behavioral Skills Training
Interventions
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Observation
Educational Intervention and Behavioral Skills Training
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Charles Cleeland, PhD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Locations
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CCOP - Carle Cancer Center
Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
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
Iowa Lutheran Hospital
Des Moines, Iowa, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Midlands Cancer Center at Midlands Community Hospital
Papillion, Nebraska, United States
CCOP - Northern New Jersey
Hackensack, New Jersey, United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States
Westmead Hospital
Westmead, New South Wales, Australia
Instituto de Enfermedades Neoplasicas
Lima, , Peru
San Juan City Hospital
San Juan, , Puerto Rico
Countries
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Other Identifiers
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ECOG-3Z93
Identifier Type: -
Identifier Source: secondary_id
NCI-P95-0068
Identifier Type: -
Identifier Source: secondary_id
CDR0000064257
Identifier Type: -
Identifier Source: org_study_id
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