S9832: Effectiveness of Telephone Counseling By Breast Cancer Survivors on the Well-Being of Women With Recurrent Breast Cancer
12 febbraio 2013 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
322
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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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, Stati Uniti, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
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Mobile, Alabama, Stati Uniti, 36688
- MBCCOP - Gulf Coast
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Arizona
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Phoenix, Arizona, Stati Uniti, 85006-2726
- CCOP - Greater Phoenix
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Phoenix, Arizona, Stati Uniti, 85012
- Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
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Tucson, Arizona, Stati Uniti, 85724
- Arizona Cancer Center
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Tucson, Arizona, Stati Uniti, 85723
- Veterans Affairs Medical Center - Tucson
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Arkansas
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Little Rock, Arkansas, Stati Uniti, 72205
- University of Arkansas for Medical Sciences
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Little Rock, Arkansas, Stati Uniti, 72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
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California
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Duarte, California, Stati Uniti, 91010-3000
- Cancer Center and Beckman Research Institute, City of Hope
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Los Angeles, California, Stati Uniti, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Stati Uniti, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles, California, Stati Uniti, 90073
- Veterans Affairs Medical Center - West Los Angeles
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Martinez, California, Stati Uniti, 94553
- Veterans Affairs Outpatient Clinic - Martinez
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Oakland, California, Stati Uniti, 94609-3305
- CCOP - Bay Area Tumor Institute
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Orange, California, Stati Uniti, 92868
- Chao Family Comprehensive Cancer Center
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Sacramento, California, Stati Uniti, 95817
- University of California Davis Medical Center
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San Francisco, California, Stati Uniti, 94121
- Veterans Affairs Medical Center - San Francisco
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San Francisco, California, Stati Uniti, 94143-0128
- UCSF Cancer Center and Cancer Research Institute
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Santa Rosa, California, Stati Uniti, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, Stati Uniti, 94535
- David Grant Medical Center
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Van Nuys, California, Stati Uniti, 91405
- Van Nuys Breast Center
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Colorado
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Denver, Colorado, Stati Uniti, 80220
- Veterans Affairs Medical Center - Denver
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Denver, Colorado, Stati Uniti, 80010
- University of Colorado Cancer Center
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District of Columbia
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Washington, District of Columbia, Stati Uniti, 20060
- MBCCOP-Howard University Cancer Center
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Florida
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Jacksonville, Florida, Stati Uniti, 32224
- Mayo Clinic
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Georgia
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Atlanta, Georgia, Stati Uniti, 30342-1701
- CCOP - Atlanta Regional
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Fort Gordon, Georgia, Stati Uniti, 30905-5650
- Dwight David Eisenhower Army Medical Center
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Hawaii
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Honolulu, Hawaii, Stati Uniti, 96813-2424
- Cancer Research Center of Hawaii
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Illinois
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Chicago, Illinois, Stati Uniti, 60612-7323
- MBCCOP - University of Illinois at Chicago
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Chicago, Illinois, Stati Uniti, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Chicago, Illinois, Stati Uniti, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
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Decatur, Illinois, Stati Uniti, 62526
- CCOP - Central Illinois
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Hines, Illinois, Stati Uniti, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Maywood, Illinois, Stati Uniti, 60153-5589
- Loyola University Medical Center
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Kansas
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Kansas City, Kansas, Stati Uniti, 66160-7353
- University of Kansas Medical Center
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Kansas City, Kansas, Stati Uniti, 66160-7390
- University of Kansas Medical Center
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Wichita, Kansas, Stati Uniti, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, Stati Uniti, 67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington, Kentucky, Stati Uniti, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Lexington, Kentucky, Stati Uniti, 40502-2236
- Veterans Affairs Medical Center - Lexington
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Louisiana
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New Orleans, Louisiana, Stati Uniti, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, Stati Uniti, 70112
- Veterans Affairs Medical Center - New Orleans
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New Orleans, Louisiana, Stati Uniti, 70112
- MBCCOP - LSU Health Sciences Center
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Shreveport, Louisiana, Stati Uniti, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Shreveport, Louisiana, Stati Uniti, 71130
- Veterans Affairs Medical Center - Shreveport
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02118
- Boston Medical Center
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Jamaica Plain, Massachusetts, Stati Uniti, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48105
- Veterans Affairs Medical Center - Ann Arbor
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Ann Arbor, Michigan, Stati Uniti, 48106
- CCOP - Ann Arbor Regional
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Ann Arbor, Michigan, Stati Uniti, 48109-0912
- University Of Michigan Comprehensive Cancer Center
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Detroit, Michigan, Stati Uniti, 48202
- Henry Ford Hospital
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Detroit, Michigan, Stati Uniti, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, Stati Uniti, 48201-1932
- Veterans Affairs Medical Center - Detroit
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Southfield, Michigan, Stati Uniti, 48075-9975
- Providence Hospital - Southfield
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Minnesota
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Duluth, Minnesota, Stati Uniti, 55805
- CCOP - Duluth
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Mississippi
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Biloxi, Mississippi, Stati Uniti, 39531-2410
- Veterans Affairs Medical Center - Biloxi
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Jackson, Mississippi, Stati Uniti, 39216-4505
- University of Mississippi Medical Center
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Jackson, Mississippi, Stati Uniti, 39216
- Veterans Affairs Medical Center - Jackson
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Keesler AFB, Mississippi, Stati Uniti, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Kansas City, Missouri, Stati Uniti, 64128
- Veterans Affairs Medical Center - Kansas City
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Kansas City, Missouri, Stati Uniti, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Stati Uniti, 63141
- CCOP - St. Louis-Cape Girardeau
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Saint Louis, Missouri, Stati Uniti, 63110
- St. Louis University Health Sciences Center
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Springfield, Missouri, Stati Uniti, 65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings, Montana, Stati Uniti, 59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque, New Mexico, Stati Uniti, 87131
- MBCCOP - University of New Mexico HSC
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New York
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Albany, New York, Stati Uniti, 12208
- Veterans Affairs Medical Center - Albany
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Buffalo, New York, Stati Uniti, 14220
- Western New York Urology Associates
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New York, New York, Stati Uniti, 10032
- Herbert Irving Comprehensive Cancer Center
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Rochester, New York, Stati Uniti, 14642
- University of Rochester Medical Center
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North Carolina
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Winston-Salem, North Carolina, Stati Uniti, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cincinnati, Ohio, Stati Uniti, 45267-0501
- Barrett Cancer Center, The University Hospital
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Cleveland, Ohio, Stati Uniti, 44195
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, Stati Uniti, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Columbus, Ohio, Stati Uniti, 43206
- CCOP - Columbus
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Dayton, Ohio, Stati Uniti, 45428
- Veterans Affairs Medical Center - Dayton
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Kettering, Ohio, Stati Uniti, 45429
- CCOP - Dayton
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Toledo, Ohio, Stati Uniti, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti, 73104
- Oklahoma Medical Research Foundation
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Oklahoma City, Oklahoma, Stati Uniti, 73104
- Veterans Affairs Medical Center - Oklahoma City
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Oregon
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Portland, Oregon, Stati Uniti, 97207
- Veterans Affairs Medical Center - Portland
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Portland, Oregon, Stati Uniti, 97225
- CCOP - Columbia River Program
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Portland, Oregon, Stati Uniti, 97239
- OHSU Cancer Institute
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South Carolina
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Charleston, South Carolina, Stati Uniti, 29425-0721
- Medical University of South Carolina
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Charleston, South Carolina, Stati Uniti, 29401-5799
- Veterans Affairs Medical Center - Charleston
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Greenville, South Carolina, Stati Uniti, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, Stati Uniti, 29303
- CCOP - Upstate Carolina
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Texas
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Fort Sam Houston, Texas, Stati Uniti, 78234-6200
- Brooke Army Medical Center
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Galveston, Texas, Stati Uniti, 77555-0565
- University of Texas Medical Branch
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Houston, Texas, Stati Uniti, 77030
- Baylor College of Medicine
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Houston, Texas, Stati Uniti, 77030
- Veterans Affairs Medical Center - Houston
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Houston, Texas, Stati Uniti, 77030-4095
- University of Texas - MD Anderson Cancer Center
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Lubbock, Texas, Stati Uniti, 79415
- Texas Tech University Health Science Center
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San Antonio, Texas, Stati Uniti, 78284
- Veterans Affairs Medical Center - San Antonio (Murphy)
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San Antonio, Texas, Stati Uniti, 78284-7845
- University of Texas Health Science Center at San Antonio
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Temple, Texas, Stati Uniti, 76504
- Veterans Affairs Medical Center - Temple
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Temple, Texas, Stati Uniti, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, Stati Uniti, 84148
- Veterans Affairs Medical Center - Salt Lake City
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Salt Lake City, Utah, Stati Uniti, 84112-5550
- Huntsman Cancer Institute
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Virginia
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Norfolk, Virginia, Stati Uniti, 23510-1115
- Eastern Virginia Medical School
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Washington
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Seattle, Washington, Stati Uniti, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, Stati Uniti, 98104
- Swedish Cancer Institute
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Seattle, Washington, Stati Uniti, 98108
- Veterans Affairs Medical Center - Seattle
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Seattle, Washington, Stati Uniti, 98109-1024
- Fred Hutchinson Cancer Research Center
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Tacoma, Washington, Stati Uniti, 98405-0986
- CCOP - Northwest
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Tacoma, Washington, Stati Uniti, 98431-5048
- Madigan Army Medical Center
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Femmina
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Nessun intervento: Control
Standard level of support after recurrence diagnosis
|
|
|
Sperimentale: Intervention
Phone intervention for patients experiencing first recurrence with quality of life questionnaires, psychosocial assessment and care.
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Questionnaire and telephone intervention
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Assess effectiveness of a telephone intervention delivered by breast cancer survivors on well-being of patients experiencing a first recurrence of breast cancer
Lasso di tempo: 6 months
|
6 months
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Examine impact of sociodemographic, clinical, and psychosocial predictors of well-being in patients experiencing a first recurrence of breast cancer.
Lasso di tempo: 6 months
|
6 months
|
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Examine changes in well-being over time since recurrence
Lasso di tempo: 6 months
|
6 months
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Carolyn Gotay, PhD, University of Hawaii Cancer Research Center
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 luglio 1998
Completamento primario (Effettivo)
1 novembre 2003
Completamento dello studio (Effettivo)
1 novembre 2003
Date di iscrizione allo studio
Primo inviato
8 marzo 2002
Primo inviato che soddisfa i criteri di controllo qualità
26 gennaio 2003
Primo Inserito (Stima)
27 gennaio 2003
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
15 febbraio 2013
Ultimo aggiornamento inviato che soddisfa i criteri QC
12 febbraio 2013
Ultimo verificato
1 febbraio 2013
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CDR0000069225
- U10CA037429 (Sovvenzione/contratto NIH degli Stati Uniti)
- S9832 (Altro identificatore: SWOG)
- NCI-P02-0209 (Altro identificatore: NCI)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .