S9832: Effectiveness of Telephone Counseling By Breast Cancer Survivors on the Well-Being of Women With Recurrent Breast Cancer
NCT ID: NCT00031772
Last Updated: 2013-02-15
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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COMPLETED
NA
322 participants
INTERVENTIONAL
1998-07-31
2003-11-30
Brief Summary
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PURPOSE: Randomized clinical trial to study the effectiveness of telephone counseling by breast cancer survivors on the well-being of women who have recurrent breast cancer.
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Detailed Description
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* Determine whether telephone counseling delivered by breast cancer survivors enhances the well-being of women with recurrent breast cancer.
* Determine the impact of sociodemographic, clinical, and psychosocial predictors of well-being in these patients.
* Determine the changes in well-being over time since disease recurrence in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 50 vs 50 and over), time since initial diagnosis (less than 2 years vs 2 years or more), and recurrence site (soft tissue without bone vs soft tissue with bone vs visceral). Patients are randomized to one of two study arms.
* Arm I (control arm): Patients receive the standard level of support by continuing to use existing resources. Patients receive written materials from the counseling group at 6 months.
* Arm II (intervention arm): Patients receive weekly telephone counseling sessions by breast cancer survivors over 4 weeks for a total of 4-8 sessions. Patients receive written materials from the counseling group after the first session.
In both arms, quality of life is assessed at baseline and at 3 and 6 months.
PROJECTED ACCRUAL: A total of 300 patients (150 per study arm) will be accrued for this study within 30 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Control
Standard level of support after recurrence diagnosis
No interventions assigned to this group
Intervention
Phone intervention for patients experiencing first recurrence with quality of life questionnaires, psychosocial assessment and care.
psychosocial assessment and care
Questionnaire and telephone intervention
Interventions
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psychosocial assessment and care
Questionnaire and telephone intervention
Eligibility Criteria
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Inclusion Criteria
* Received prior definitive surgical treatment for stage I-IIIa breast cancer with or without adjuvant chemotherapy, hormonal therapy, and/or radiotherapy
* No more than 56 days since diagnosis of first recurrence
* Any distant metastatic site, chest wall recurrence, scar recurrence, or nodal recurrence
* No ipsilateral breast tumor recurrence after lumpectomy or isolated contralateral new primary breast tumors
* Receiving or planning to receive first therapy for recurrence
* No prior therapy for this recurrence except surgical treatment for in-breast relapse after lumpectomy or local palliative radiotherapy
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* Not specified
Sex:
* Female
Menopausal status:
* Not specified
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* No psychiatric diagnosis that would preclude study
* Must be able to read and understand English
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
Chemotherapy:
* See Disease Characteristics
Endocrine therapy:
* See Disease Characteristics
Radiotherapy:
* See Disease Characteristics
Surgery:
* See Disease Characteristics
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Carolyn Gotay, PhD
Role: STUDY_CHAIR
University of Hawaii Cancer Research Center
Locations
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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
MBCCOP - Gulf Coast
Mobile, Alabama, United States
CCOP - Greater Phoenix
Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States
Arizona Cancer Center
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, United States
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
Chao Family Comprehensive Cancer Center
Orange, California, United States
University of California Davis Medical Center
Sacramento, California, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States
David Grant Medical Center
Travis Air Force Base, California, United States
Van Nuys Breast Center
Van Nuys, California, United States
University of Colorado Cancer Center
Denver, Colorado, United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States
MBCCOP-Howard University Cancer Center
Washington D.C., District of Columbia, United States
Mayo Clinic
Jacksonville, Florida, United States
CCOP - Atlanta Regional
Atlanta, Georgia, United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States
CCOP - Central Illinois
Decatur, Illinois, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, United States
Boston Medical Center
Boston, Massachusetts, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Providence Hospital - Southfield
Southfield, Michigan, United States
CCOP - Duluth
Duluth, Minnesota, United States
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, United States
Keesler Medical Center - Keesler AFB
Keesler Air Force Base, Mississippi, United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
St. Louis University Health Sciences Center
St Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States
Veterans Affairs Medical Center - Albany
Albany, New York, United States
Western New York Urology Associates
Buffalo, New York, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States
CCOP - Dayton
Kettering, Ohio, United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, United States
CCOP - Columbia River Program
Portland, Oregon, United States
OHSU Cancer Institute
Portland, Oregon, United States
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
CCOP - Greenville
Greenville, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Veterans Affairs Medical Center - Houston
Houston, Texas, United States
Texas Tech University Health Science Center
Lubbock, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States
Veterans Affairs Medical Center - Temple
Temple, Texas, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, United States
Swedish Cancer Institute
Seattle, Washington, United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
CCOP - Northwest
Tacoma, Washington, United States
Madigan Army Medical Center
Tacoma, Washington, United States
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
Countries
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References
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Gotay CC, Moinpour CM, Unger JM, Jiang CS, Coleman D, Martino S, Parker BJ, Bearden JD, Dakhil S, Gross HM, Lippman S, Albain KS. Impact of a peer-delivered telephone intervention for women experiencing a breast cancer recurrence. J Clin Oncol. 2007 May 20;25(15):2093-9. doi: 10.1200/JCO.2006.07.4674.
Gotay CC, Moinpour CM, Jiang CS, et al.: Enhancing well-being during breast cancer recurrence: preliminary findings from a phase III study. [Abstract] Breast Cancer Res Treat 88 (Suppl 1): A-3080, 2004.
Other Identifiers
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S9832
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-P02-0209
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000069225
Identifier Type: -
Identifier Source: org_study_id
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