S9832: Effectiveness of Telephone Counseling By Breast Cancer Survivors on the Well-Being of Women With Recurrent Breast Cancer
12. februar 2013 oppdatert av: Southwest Oncology Group
Enhancing Well-Being During Breast Cancer Recurrence. SWOG Study S9832.
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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
322
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
- British Columbia Cancer Agency
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Alabama
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Birmingham, Alabama, Forente stater, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
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Mobile, Alabama, Forente stater, 36688
- MBCCOP - Gulf Coast
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Arizona
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Phoenix, Arizona, Forente stater, 85006-2726
- CCOP - Greater Phoenix
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Phoenix, Arizona, Forente stater, 85012
- Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
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Tucson, Arizona, Forente stater, 85724
- Arizona Cancer Center
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Tucson, Arizona, Forente stater, 85723
- Veterans Affairs Medical Center - Tucson
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Arkansas
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Little Rock, Arkansas, Forente stater, 72205
- University of Arkansas for Medical Sciences
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Little Rock, Arkansas, Forente stater, 72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
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California
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Duarte, California, Forente stater, 91010-3000
- Cancer Center and Beckman Research Institute, City of Hope
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Los Angeles, California, Forente stater, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Forente stater, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles, California, Forente stater, 90073
- Veterans Affairs Medical Center - West Los Angeles
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Martinez, California, Forente stater, 94553
- Veterans Affairs Outpatient Clinic - Martinez
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Oakland, California, Forente stater, 94609-3305
- CCOP - Bay Area Tumor Institute
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Orange, California, Forente stater, 92868
- Chao Family Comprehensive Cancer Center
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Sacramento, California, Forente stater, 95817
- University of California Davis Medical Center
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San Francisco, California, Forente stater, 94121
- Veterans Affairs Medical Center - San Francisco
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San Francisco, California, Forente stater, 94143-0128
- UCSF Cancer Center and Cancer Research Institute
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Santa Rosa, California, Forente stater, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, Forente stater, 94535
- David Grant Medical Center
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Van Nuys, California, Forente stater, 91405
- Van Nuys Breast Center
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Colorado
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Denver, Colorado, Forente stater, 80220
- Veterans Affairs Medical Center - Denver
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Denver, Colorado, Forente stater, 80010
- University of Colorado Cancer Center
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District of Columbia
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Washington, District of Columbia, Forente stater, 20060
- MBCCOP-Howard University Cancer Center
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Florida
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Jacksonville, Florida, Forente stater, 32224
- Mayo Clinic
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Georgia
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Atlanta, Georgia, Forente stater, 30342-1701
- CCOP - Atlanta Regional
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Fort Gordon, Georgia, Forente stater, 30905-5650
- Dwight David Eisenhower Army Medical Center
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Hawaii
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Honolulu, Hawaii, Forente stater, 96813-2424
- Cancer Research Center of Hawaii
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Illinois
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Chicago, Illinois, Forente stater, 60612-7323
- MBCCOP - University of Illinois at Chicago
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Chicago, Illinois, Forente stater, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Chicago, Illinois, Forente stater, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
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Decatur, Illinois, Forente stater, 62526
- CCOP - Central Illinois
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Hines, Illinois, Forente stater, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Maywood, Illinois, Forente stater, 60153-5589
- Loyola University Medical Center
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Kansas
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Kansas City, Kansas, Forente stater, 66160-7353
- University of Kansas Medical Center
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Kansas City, Kansas, Forente stater, 66160-7390
- University of Kansas Medical Center
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Wichita, Kansas, Forente stater, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, Forente stater, 67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington, Kentucky, Forente stater, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Lexington, Kentucky, Forente stater, 40502-2236
- Veterans Affairs Medical Center - Lexington
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Louisiana
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New Orleans, Louisiana, Forente stater, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, Forente stater, 70112
- Veterans Affairs Medical Center - New Orleans
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New Orleans, Louisiana, Forente stater, 70112
- MBCCOP - LSU Health Sciences Center
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Shreveport, Louisiana, Forente stater, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Shreveport, Louisiana, Forente stater, 71130
- Veterans Affairs Medical Center - Shreveport
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Massachusetts
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Boston, Massachusetts, Forente stater, 02118
- Boston Medical Center
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Jamaica Plain, Massachusetts, Forente stater, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, Forente stater, 48105
- Veterans Affairs Medical Center - Ann Arbor
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Ann Arbor, Michigan, Forente stater, 48106
- CCOP - Ann Arbor Regional
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Ann Arbor, Michigan, Forente stater, 48109-0912
- University Of Michigan Comprehensive Cancer Center
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Detroit, Michigan, Forente stater, 48202
- Henry Ford Hospital
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Detroit, Michigan, Forente stater, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, Forente stater, 48201-1932
- Veterans Affairs Medical Center - Detroit
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Southfield, Michigan, Forente stater, 48075-9975
- Providence Hospital - Southfield
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Minnesota
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Duluth, Minnesota, Forente stater, 55805
- CCOP - Duluth
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Mississippi
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Biloxi, Mississippi, Forente stater, 39531-2410
- Veterans Affairs Medical Center - Biloxi
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Jackson, Mississippi, Forente stater, 39216-4505
- University of Mississippi Medical Center
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Jackson, Mississippi, Forente stater, 39216
- Veterans Affairs Medical Center - Jackson
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Keesler AFB, Mississippi, Forente stater, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Kansas City, Missouri, Forente stater, 64128
- Veterans Affairs Medical Center - Kansas City
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Kansas City, Missouri, Forente stater, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Forente stater, 63141
- CCOP - St. Louis-Cape Girardeau
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Saint Louis, Missouri, Forente stater, 63110
- St. Louis University Health Sciences Center
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Springfield, Missouri, Forente stater, 65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings, Montana, Forente stater, 59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque, New Mexico, Forente stater, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque, New Mexico, Forente stater, 87131
- MBCCOP - University of New Mexico HSC
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New York
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Albany, New York, Forente stater, 12208
- Veterans Affairs Medical Center - Albany
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Buffalo, New York, Forente stater, 14220
- Western New York Urology Associates
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New York, New York, Forente stater, 10032
- Herbert Irving Comprehensive Cancer Center
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Rochester, New York, Forente stater, 14642
- University of Rochester Medical Center
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North Carolina
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Winston-Salem, North Carolina, Forente stater, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Ohio
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Cincinnati, Ohio, Forente stater, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cincinnati, Ohio, Forente stater, 45267-0501
- Barrett Cancer Center, The University Hospital
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Cleveland, Ohio, Forente stater, 44195
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, Forente stater, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Columbus, Ohio, Forente stater, 43206
- CCOP - Columbus
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Dayton, Ohio, Forente stater, 45428
- Veterans Affairs Medical Center - Dayton
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Kettering, Ohio, Forente stater, 45429
- CCOP - Dayton
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Toledo, Ohio, Forente stater, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73104
- Oklahoma Medical Research Foundation
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Oklahoma City, Oklahoma, Forente stater, 73104
- Veterans Affairs Medical Center - Oklahoma City
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Oregon
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Portland, Oregon, Forente stater, 97207
- Veterans Affairs Medical Center - Portland
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Portland, Oregon, Forente stater, 97225
- CCOP - Columbia River Program
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Portland, Oregon, Forente stater, 97239
- OHSU Cancer Institute
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South Carolina
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Charleston, South Carolina, Forente stater, 29425-0721
- Medical University of South Carolina
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Charleston, South Carolina, Forente stater, 29401-5799
- Veterans Affairs Medical Center - Charleston
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Greenville, South Carolina, Forente stater, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, Forente stater, 29303
- CCOP - Upstate Carolina
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Texas
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Fort Sam Houston, Texas, Forente stater, 78234-6200
- Brooke Army Medical Center
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Galveston, Texas, Forente stater, 77555-0565
- University of Texas Medical Branch
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Houston, Texas, Forente stater, 77030
- Baylor College of Medicine
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Houston, Texas, Forente stater, 77030
- Veterans Affairs Medical Center - Houston
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Houston, Texas, Forente stater, 77030-4095
- University of Texas - MD Anderson Cancer Center
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Lubbock, Texas, Forente stater, 79415
- Texas Tech University Health Science Center
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San Antonio, Texas, Forente stater, 78284
- Veterans Affairs Medical Center - San Antonio (Murphy)
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San Antonio, Texas, Forente stater, 78284-7845
- University of Texas Health Science Center at San Antonio
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Temple, Texas, Forente stater, 76504
- Veterans Affairs Medical Center - Temple
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Temple, Texas, Forente stater, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, Forente stater, 84148
- Veterans Affairs Medical Center - Salt Lake City
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Salt Lake City, Utah, Forente stater, 84112-5550
- Huntsman Cancer Institute
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Virginia
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Norfolk, Virginia, Forente stater, 23510-1115
- Eastern Virginia Medical School
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Washington
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Seattle, Washington, Forente stater, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, Forente stater, 98104
- Swedish Cancer Institute
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Seattle, Washington, Forente stater, 98108
- Veterans Affairs Medical Center - Seattle
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Seattle, Washington, Forente stater, 98109-1024
- Fred Hutchinson Cancer Research Center
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Tacoma, Washington, Forente stater, 98405-0986
- CCOP - Northwest
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Tacoma, Washington, Forente stater, 98431-5048
- Madigan Army Medical Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Control
Standard level of support after recurrence diagnosis
|
|
|
Eksperimentell: Intervention
Phone intervention for patients experiencing first recurrence with quality of life questionnaires, psychosocial assessment and care.
|
Questionnaire and telephone intervention
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Assess effectiveness of a telephone intervention delivered by breast cancer survivors on well-being of patients experiencing a first recurrence of breast cancer
Tidsramme: 6 months
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Examine impact of sociodemographic, clinical, and psychosocial predictors of well-being in patients experiencing a first recurrence of breast cancer.
Tidsramme: 6 months
|
6 months
|
|
Examine changes in well-being over time since recurrence
Tidsramme: 6 months
|
6 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Carolyn Gotay, PhD, University of Hawaii Cancer Research Center
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juli 1998
Primær fullføring (Faktiske)
1. november 2003
Studiet fullført (Faktiske)
1. november 2003
Datoer for studieregistrering
Først innsendt
8. mars 2002
Først innsendt som oppfylte QC-kriteriene
26. januar 2003
Først lagt ut (Anslag)
27. januar 2003
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
15. februar 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. februar 2013
Sist bekreftet
1. februar 2013
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CDR0000069225
- U10CA037429 (U.S. NIH-stipend/kontrakt)
- S9832 (Annen identifikator: SWOG)
- NCI-P02-0209 (Annen identifikator: NCI)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .