Enhancing Well-Being During Breast Cancer Recurrence. SWOG Study S9832.
N/A
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Psychosocial Effects of Cancer and Its Treatment
Female
Breast Cancer, Psychosocial Effects of Cancer and Its Treatment
Trial Information
Enhancing Well-Being During Breast Cancer Recurrence. SWOG Study S9832.
OBJECTIVES:
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Outcome Measure:
Assess effectiveness of a telephone intervention delivered by breast cancer survivors on well-being of patients experiencing a first recurrence of breast cancer
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Carolyn Gotay, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Hawaii Cancer Research Center
Authority:
United States: Federal Government
Study ID:
CDR0000069225
NCT ID:
NCT00031772
Start Date:
July 1998
Completion Date:
November 2003
Related Keywords:
- Breast Cancer
- Psychosocial Effects of Cancer and Its Treatment
- recurrent breast cancer
- psychosocial effects of cancer and its treatment
- Breast Neoplasms
Name | Location |
|---|---|
| Baylor College of Medicine | Houston, Texas 77030 |
| Arizona Cancer Center | Tucson, Arizona 85724 |
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
| Chao Family Comprehensive Cancer Center | Orange, California 92868 |
| University of Colorado Cancer Center | Denver, Colorado 80262 |
| Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky 40536-0084 |
| CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
| Barrett Cancer Center, The University Hospital | Cincinnati, Ohio 45219 |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
| Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
| University of California Davis Medical Center | Sacramento, California 95817 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| CCOP - Greater Phoenix | Phoenix, Arizona 85006-2726 |
| CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
| CCOP - Duluth | Duluth, Minnesota 55805 |
| Loyola University Medical Center | Maywood, Illinois 60153 |
| CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
| Henry Ford Hospital | Detroit, Michigan 48202 |
| Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
| Veterans Affairs Outpatient Clinic - Martinez | Martinez, California 94553 |
| CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
| CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
| David Grant Medical Center | Travis Air Force Base, California 94535 |
| CCOP - Central Illinois | Springfield, Illinois 62526 |
| Veterans Affairs Medical Center - Lexington | Lexington, Kentucky 40511-1093 |
| Tulane University School of Medicine | New Orleans, Louisiana 70112 |
| Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain, Massachusetts 02130 |
| Veterans Affairs Medical Center - Ann Arbor | Ann Arbor, Michigan 48105 |
| St. Louis University Health Sciences Center | Saint Louis, Missouri 63110-0250 |
| CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| Veterans Affairs Medical Center - Albany | Albany, New York 12208 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| CCOP - Columbia River Program | Portland, Oregon 97213 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| University of Texas Medical Branch | Galveston, Texas 77555-1329 |
| Swedish Cancer Institute | Seattle, Washington 98104 |
| MBCCOP - University of Illinois at Chicago | Chicago, Illinois 60612 |
| MBCCOP - University of New Mexico HSC | Albuquerque, New Mexico 87131 |
| CCOP - Scott and White Hospital | Temple, Texas 76508 |
| Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| MBCCOP - Gulf Coast | Mobile, Alabama 36688 |
| Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) | Phoenix, Arizona 85012 |
| Veterans Affairs Medical Center - Tucson | Tucson, Arizona 85723 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock, Arkansas 72205 |
| Cancer Center and Beckman Research Institute, City of Hope | Duarte, California 91010-3000 |
| Veterans Affairs Medical Center - West Los Angeles | Los Angeles, California 90073 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
| Dwight David Eisenhower Army Medical Center | Fort Gordon, Georgia 30905-5650 |
| Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago, Illinois 60612 |
| Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines, Illinois 60141 |
| University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Veterans Affairs Medical Center - Wichita | Wichita, Kansas 67218 |
| MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
| Louisiana State University Health Sciences Center - Shreveport | Shreveport, Louisiana 71130-3932 |
| Veterans Affairs Medical Center - Shreveport | Shreveport, Louisiana 71130 |
| Boston Medical Center | Boston, Massachusetts 02118 |
| Veterans Affairs Medical Center - Detroit | Detroit, Michigan 48201-1932 |
| Providence Hospital - Southfield | Southfield, Michigan 48075-9975 |
| Veterans Affairs Medical Center - Biloxi | Biloxi, Mississippi 39531-2410 |
| Veterans Affairs Medical Center - Jackson | Jackson, Mississippi 39216 |
| Keesler Medical Center - Keesler AFB | Keesler AFB, Mississippi 39534-2576 |
| Veterans Affairs Medical Center - Kansas City | Kansas City, Missouri 64128 |
| CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
| Veterans Affairs Medical Center - Albuquerque | Albuquerque, New Mexico 87108-5138 |
| Herbert Irving Comprehensive Cancer Center | New York, New York 10032 |
| University of Rochester Medical Center | Rochester, New York 14642 |
| Veterans Affairs Medical Center - Cincinnati | Cincinnati, Ohio 45220-2288 |
| Oklahoma Medical Research Foundation | Oklahoma City, Oklahoma 73104 |
| Veterans Affairs Medical Center - Oklahoma City | Oklahoma City, Oklahoma 73104 |
| OHSU Cancer Institute | Portland, Oregon 97239 |
| Veterans Affairs Medical Center - Portland | Portland, Oregon 97207 |
| Veterans Affairs Medical Center - Charleston | Charleston, South Carolina 29401-5799 |
| Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
| Veterans Affairs Medical Center - Houston | Houston, Texas 77030 |
| Texas Tech University Health Science Center | Lubbock, Texas 79415 |
| Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio, Texas 78284 |
| Veterans Affairs Medical Center - Temple | Temple, Texas 76504 |
| Veterans Affairs Medical Center - Salt Lake City | Salt Lake City, Utah 84148 |
| CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
| Veterans Affairs Medical Center - Seattle | Seattle, Washington 98108 |
| CCOP - Northwest | Tacoma, Washington 98405-0986 |
| Madigan Army Medical Center | Tacoma, Washington 98431-5048 |
| Veterans Affairs Medical Center - New Orleans | New Orleans, Louisiana 70112 |
| Veterans Affairs Medical Center - San Francisco | San Francisco, California 94121 |
| Eastern Virginia Medical School | Norfolk, Virginia 23507 |
| MBCCOP-Howard University Cancer Center | Washington, District of Columbia 20060 |
| Mayo Clinic | Jacksonville, Florida 32224 |
| Western New York Urology Associates | Buffalo, New York 14220 |
| Van Nuys Breast Center | Van Nuys, California 91405 |
