Breast Cancer Clinical Trial
S9832: Effectiveness of Telephone Counseling By Breast Cancer Survivors on the Well-Being of Women With Recurrent Breast Cancer
Summary
RATIONALE: Telephone counseling by breast cancer survivors may enhance the well-being and quality of life of women who have recurrent breast cancer.
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.
Full Description
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.
Eligibility 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
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There are 97 Locations for this study
Birmingham Alabama, 35294, United States
Mobile Alabama, 36688, United States
Phoenix Arizona, 85006, United States
Phoenix Arizona, 85012, United States
Tucson Arizona, 85723, United States
Tucson Arizona, 85724, United States
Little Rock Arkansas, 72205, United States
Little Rock Arkansas, 72205, United States
Duarte California, 91010, United States
Los Angeles California, 90033, United States
Los Angeles California, 90073, United States
Los Angeles California, 90095, United States
Martinez California, 94553, United States
Oakland California, 94609, United States
Orange California, 92868, United States
Sacramento California, 95817, United States
San Francisco California, 94121, United States
San Francisco California, 94143, United States
Santa Rosa California, 95403, United States
Travis Air Force Base California, 94535, United States
Van Nuys California, 91405, United States
Denver Colorado, 80010, United States
Denver Colorado, 80220, United States
Washington District of Columbia, 20060, United States
Jacksonville Florida, 32224, United States
Atlanta Georgia, 30342, United States
Fort Gordon Georgia, 30905, United States
Honolulu Hawaii, 96813, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60612, United States
Decatur Illinois, 62526, United States
Hines Illinois, 60141, United States
Maywood Illinois, 60153, United States
Kansas City Kansas, 66160, United States
Kansas City Kansas, 66160, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67218, United States
Lexington Kentucky, 40502, United States
Lexington Kentucky, 40536, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70112, United States
Shreveport Louisiana, 71130, United States
Shreveport Louisiana, 71130, United States
Boston Massachusetts, 02118, United States
Jamaica Plain Massachusetts, 02130, United States
Ann Arbor Michigan, 48105, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Southfield Michigan, 48075, United States
Duluth Minnesota, 55805, United States
Biloxi Mississippi, 39531, United States
Jackson Mississippi, 39216, United States
Jackson Mississippi, 39216, United States
Keesler AFB Mississippi, 39534, United States
Kansas City Missouri, 64128, United States
Kansas City Missouri, 64131, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63141, United States
Springfield Missouri, 65807, United States
Billings Montana, 59101, United States
Albuquerque New Mexico, 87108, United States
Albuquerque New Mexico, 87131, United States
Albany New York, 12208, United States
Buffalo New York, 14220, United States
New York New York, 10032, United States
Rochester New York, 14642, United States
Winston-Salem North Carolina, 27104, United States
Cincinnati Ohio, 45220, United States
Cincinnati Ohio, 45267, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43206, United States
Columbus Ohio, 43210, United States
Dayton Ohio, 45428, United States
Kettering Ohio, 45429, United States
Toledo Ohio, 43623, United States
Oklahoma City Oklahoma, 73104, United States
Oklahoma City Oklahoma, 73104, United States
Portland Oregon, 97207, United States
Portland Oregon, 97225, United States
Portland Oregon, 97239, United States
Charleston South Carolina, 29401, United States
Charleston South Carolina, 29425, United States
Greenville South Carolina, 29615, United States
Spartanburg South Carolina, 29303, United States
Fort Sam Houston Texas, 78234, United States
Galveston Texas, 77555, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Lubbock Texas, 79415, United States
San Antonio Texas, 78284, United States
San Antonio Texas, 78284, United States
Temple Texas, 76504, United States
Temple Texas, 76508, United States
Salt Lake City Utah, 84112, United States
Salt Lake City Utah, 84148, United States
Norfolk Virginia, 23510, United States
Seattle Washington, 98101, United States
Seattle Washington, 98104, United States
Seattle Washington, 98108, United States
Seattle Washington, 98109, United States
Tacoma Washington, 98405, United States
Tacoma Washington, 98431, United States
Vancouver British Columbia, V5Z 4, Canada
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