S9832: Effectiveness of Telephone Counseling By Breast Cancer Survivors on the Well-Being of Women With Recurrent Breast Cancer
12. februar 2013 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
322
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
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, Forenede Stater, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
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Mobile, Alabama, Forenede Stater, 36688
- MBCCOP - Gulf Coast
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Arizona
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Phoenix, Arizona, Forenede Stater, 85006-2726
- CCOP - Greater Phoenix
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Phoenix, Arizona, Forenede Stater, 85012
- Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
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Tucson, Arizona, Forenede Stater, 85724
- Arizona Cancer Center
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Tucson, Arizona, Forenede Stater, 85723
- Veterans Affairs Medical Center - Tucson
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- University of Arkansas for Medical Sciences
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Little Rock, Arkansas, Forenede Stater, 72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
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California
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Duarte, California, Forenede Stater, 91010-3000
- Cancer Center and Beckman Research Institute, City of Hope
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Los Angeles, California, Forenede Stater, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Forenede Stater, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles, California, Forenede Stater, 90073
- Veterans Affairs Medical Center - West Los Angeles
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Martinez, California, Forenede Stater, 94553
- Veterans Affairs Outpatient Clinic - Martinez
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Oakland, California, Forenede Stater, 94609-3305
- CCOP - Bay Area Tumor Institute
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Orange, California, Forenede Stater, 92868
- Chao Family Comprehensive Cancer Center
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Sacramento, California, Forenede Stater, 95817
- University of California Davis Medical Center
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San Francisco, California, Forenede Stater, 94121
- Veterans Affairs Medical Center - San Francisco
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San Francisco, California, Forenede Stater, 94143-0128
- UCSF Cancer Center and Cancer Research Institute
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Santa Rosa, California, Forenede Stater, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, Forenede Stater, 94535
- David Grant Medical Center
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Van Nuys, California, Forenede Stater, 91405
- Van Nuys Breast Center
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Colorado
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Denver, Colorado, Forenede Stater, 80220
- Veterans Affairs Medical Center - Denver
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Denver, Colorado, Forenede Stater, 80010
- University of Colorado Cancer Center
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20060
- MBCCOP-Howard University Cancer Center
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Florida
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Jacksonville, Florida, Forenede Stater, 32224
- Mayo Clinic
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Georgia
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Atlanta, Georgia, Forenede Stater, 30342-1701
- CCOP - Atlanta Regional
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Fort Gordon, Georgia, Forenede Stater, 30905-5650
- Dwight David Eisenhower Army Medical Center
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96813-2424
- Cancer Research Center of Hawaii
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Illinois
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Chicago, Illinois, Forenede Stater, 60612-7323
- MBCCOP - University of Illinois at Chicago
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Chicago, Illinois, Forenede Stater, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Chicago, Illinois, Forenede Stater, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
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Decatur, Illinois, Forenede Stater, 62526
- CCOP - Central Illinois
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Hines, Illinois, Forenede Stater, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Maywood, Illinois, Forenede Stater, 60153-5589
- Loyola University Medical Center
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160-7353
- University of Kansas Medical Center
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Kansas City, Kansas, Forenede Stater, 66160-7390
- University of Kansas Medical Center
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Wichita, Kansas, Forenede Stater, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, Forenede Stater, 67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Lexington, Kentucky, Forenede Stater, 40502-2236
- Veterans Affairs Medical Center - Lexington
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, Forenede Stater, 70112
- Veterans Affairs Medical Center - New Orleans
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New Orleans, Louisiana, Forenede Stater, 70112
- MBCCOP - LSU Health Sciences Center
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Shreveport, Louisiana, Forenede Stater, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Shreveport, Louisiana, Forenede Stater, 71130
- Veterans Affairs Medical Center - Shreveport
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02118
- Boston Medical Center
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Jamaica Plain, Massachusetts, Forenede Stater, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48105
- Veterans Affairs Medical Center - Ann Arbor
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Ann Arbor, Michigan, Forenede Stater, 48106
- CCOP - Ann Arbor Regional
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Ann Arbor, Michigan, Forenede Stater, 48109-0912
- University of Michigan Comprehensive Cancer Center
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Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Hospital
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Detroit, Michigan, Forenede Stater, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, Forenede Stater, 48201-1932
- Veterans Affairs Medical Center - Detroit
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Southfield, Michigan, Forenede Stater, 48075-9975
- Providence Hospital - Southfield
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Minnesota
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Duluth, Minnesota, Forenede Stater, 55805
- CCOP - Duluth
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Mississippi
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Biloxi, Mississippi, Forenede Stater, 39531-2410
- Veterans Affairs Medical Center - Biloxi
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Jackson, Mississippi, Forenede Stater, 39216-4505
- University of Mississippi Medical Center
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Jackson, Mississippi, Forenede Stater, 39216
- Veterans Affairs Medical Center - Jackson
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Keesler AFB, Mississippi, Forenede Stater, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Kansas City, Missouri, Forenede Stater, 64128
- Veterans Affairs Medical Center - Kansas City
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Kansas City, Missouri, Forenede Stater, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Forenede Stater, 63141
- CCOP - St. Louis-Cape Girardeau
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Saint Louis, Missouri, Forenede Stater, 63110
- St. Louis University Health Sciences Center
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Springfield, Missouri, Forenede Stater, 65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings, Montana, Forenede Stater, 59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque, New Mexico, Forenede Stater, 87131
- MBCCOP - University of New Mexico HSC
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New York
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Albany, New York, Forenede Stater, 12208
- Veterans Affairs Medical Center - Albany
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Buffalo, New York, Forenede Stater, 14220
- Western New York Urology Associates
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New York, New York, Forenede Stater, 10032
- Herbert Irving Comprehensive Cancer Center
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Rochester, New York, Forenede Stater, 14642
- University of Rochester Medical Center
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North Carolina
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Winston-Salem, North Carolina, Forenede Stater, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cincinnati, Ohio, Forenede Stater, 45267-0501
- Barrett Cancer Center, The University Hospital
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Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, Forenede Stater, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Columbus, Ohio, Forenede Stater, 43206
- CCOP - Columbus
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Dayton, Ohio, Forenede Stater, 45428
- Veterans Affairs Medical Center - Dayton
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Kettering, Ohio, Forenede Stater, 45429
- CCOP - Dayton
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Toledo, Ohio, Forenede Stater, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- Oklahoma Medical Research Foundation
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- Veterans Affairs Medical Center - Oklahoma City
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Oregon
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Portland, Oregon, Forenede Stater, 97207
- Veterans Affairs Medical Center - Portland
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Portland, Oregon, Forenede Stater, 97225
- CCOP - Columbia River Program
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Portland, Oregon, Forenede Stater, 97239
- OHSU Cancer Institute
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425-0721
- Medical University of South Carolina
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Charleston, South Carolina, Forenede Stater, 29401-5799
- Veterans Affairs Medical Center - Charleston
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Greenville, South Carolina, Forenede Stater, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, Forenede Stater, 29303
- CCOP - Upstate Carolina
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Texas
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Fort Sam Houston, Texas, Forenede Stater, 78234-6200
- Brooke Army Medical Center
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Galveston, Texas, Forenede Stater, 77555-0565
- University of Texas Medical Branch
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Houston, Texas, Forenede Stater, 77030
- Baylor College of Medicine
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Houston, Texas, Forenede Stater, 77030
- Veterans Affairs Medical Center - Houston
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Houston, Texas, Forenede Stater, 77030-4095
- University of Texas - MD Anderson Cancer Center
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Lubbock, Texas, Forenede Stater, 79415
- Texas Tech University Health Science Center
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San Antonio, Texas, Forenede Stater, 78284
- Veterans Affairs Medical Center - San Antonio (Murphy)
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San Antonio, Texas, Forenede Stater, 78284-7845
- University of Texas Health Science Center at San Antonio
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Temple, Texas, Forenede Stater, 76504
- Veterans Affairs Medical Center - Temple
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Temple, Texas, Forenede Stater, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, Forenede Stater, 84148
- Veterans Affairs Medical Center - Salt Lake City
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Salt Lake City, Utah, Forenede Stater, 84112-5550
- Huntsman Cancer Institute
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Virginia
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Norfolk, Virginia, Forenede Stater, 23510-1115
- Eastern Virginia Medical School
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Washington
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Seattle, Washington, Forenede Stater, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, Forenede Stater, 98104
- Swedish Cancer Institute
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Seattle, Washington, Forenede Stater, 98108
- Veterans Affairs Medical Center - Seattle
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Seattle, Washington, Forenede Stater, 98109-1024
- Fred Hutchinson Cancer Research Center
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Tacoma, Washington, Forenede Stater, 98405-0986
- CCOP - Northwest
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Tacoma, Washington, Forenede Stater, 98431-5048
- Madigan Army Medical Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Control
Standard level of support after recurrence diagnosis
|
|
|
Eksperimentel: Intervention
Phone intervention for patients experiencing first recurrence with quality of life questionnaires, psychosocial assessment and care.
|
Questionnaire and telephone intervention
|
Hvad måler undersøgelsen?
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Carolyn Gotay, PhD, University of Hawaii Cancer Research Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 1998
Primær færdiggørelse (Faktiske)
1. november 2003
Studieafslutning (Faktiske)
1. november 2003
Datoer for studieregistrering
Først indsendt
8. marts 2002
Først indsendt, der opfyldte QC-kriterier
26. januar 2003
Først opslået (Skøn)
27. januar 2003
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
15. februar 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. februar 2013
Sidst verificeret
1. februar 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CDR0000069225
- U10CA037429 (U.S. NIH-bevilling/kontrakt)
- S9832 (Anden identifikator: SWOG)
- NCI-P02-0209 (Anden identifikator: NCI)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .