Chemotherapy Decisions and Outcomes in Older Women With Newly Diagnosed Breast Cancer
NCT ID: NCT00068328
Last Updated: 2017-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1706 participants
OBSERVATIONAL
2003-08-31
2016-12-31
Brief Summary
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PURPOSE: This clinical trial is studying how a patient's treatment preferences and decisions about chemotherapy affect the outcome of treatment in older women with newly diagnosed breast cancer.
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Detailed Description
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* Determine the relationship between preferences and chemotherapy decisions in women age 65 and over with operable, newly diagnosed breast cancer.
* Determine how factors that could be targets for intervention affect the relationship between preferences and chemotherapy decisions in these patients.
* Determine the relationships between preference-based chemotherapy decisions, quality of life, and satisfaction with treatment decisions in these patients.
* Determine the disease-free survival and competing causes of mortality of these patients.
* Determine the types of physician providers who care for older breast cancer survivors after initial cancer treatment is completed and explore how women decide about which physicians to see.
* Measure quality indicators for the survivorship phase of care and evaluate if quality varies by type of physician provider model.
* Determine if long-term patient-reported satisfaction varies as a function of physician model for providing follow-up care post-treatment.
* Determine whether physician-patient communication and coordination of care after treatment ends mediate follow-up quality and outcomes post-treatment.
OUTLINE: This is a cohort study.
Patients participate in interviews over 30-45 minutes at baseline, at 6 months, and at 1 and 2 years.
Patients are followed annually for at least 5 years.
PROJECTED ACCRUAL: A total of 1,296 patients will be accrued for this study within 18-24 months.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Group 1
Patients participate in interviews over 30-45 minutes at baseline, at 6 months, and at 1 and 2 years.
Patients are followed annually for at least 5 years.
psychosocial assessment and care
quality-of-life assessment
Interventions
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psychosocial assessment and care
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed primary adenocarcinoma of the breast
* Operable disease
* Invasive and unilateral tumor
* No more than 20 weeks since diagnosis
* T1-4 (tumor size ≥ 1 cm), N0, M0 OR
* T1-4, N1-3, M0
* No prior carcinoma in situ, lobular carcinoma in situ, ductal carcinoma in situ, or invasive breast cancer
* Hormone receptor status:
* Any estrogen receptor status
PATIENT CHARACTERISTICS:
Age
* 65 and over
Sex
* Female
Other
* No other malignancy except those for which the patient has completed treatment AND is considered to be at less than 30% risk of recurrence
* History of non-melanoma skin cancer allowed
* Sufficient cognitive function to consent to and complete interviews
* English or Spanish speaking
65 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Jeanne Mandelblatt, MD, MPH
Role: STUDY_CHAIR
Lombardi Comprehensive Cancer Center
Locations
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Camino Medical Group - Treatment Center
Mountain View, California, United States
Palo Alto Medical Foundation
Palo Alto, California, United States
Pismo Beach, California, United States
Bendheim Cancer Center at Greenwich Hospital
Greenwich, Connecticut, United States
Washington Cancer Institute at Washington Hospital Center
Washington D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Cancer Center of South Florida Foundation, Incorporated
Lake Worth, Florida, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States
La Grange Memorial Hospital
La Grange, Illinois, United States
Center for Cancer Care at OSF Saint Anthony Medical Center
Rockford, Illinois, United States
Elkhart Clinic, LLC
Elkhart, Indiana, United States
Michiana Hematology-Oncology, PC - Elkhart
Elkhart, Indiana, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Howard Community Hospital
Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States
Suniti Medical Corporation
Merrillville, Indiana, United States
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center
Mishawaka, Indiana, United States
Michiana Hematology Oncology PC - Plymouth
Plymouth, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
South Bend Clinic
South Bend, Indiana, United States
Michiana Hematology Oncology PC - La Porte
Westville, Indiana, United States
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough, Maine, United States
Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
Baltimore, Maryland, United States
Sturdy Memorial Hospital
Attleboro, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber/Brigham and Women's Cancer Center
Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Addison Gilbert Hospital
Gloucester, Massachusetts, United States
Cape Cod Hospital
Hyannis, Massachusetts, United States
Lowell General Hospital
Lowell, Massachusetts, United States
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States
Mecosta County Medical Center
Big Rapids, Michigan, United States
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States
Mercy General Health Partners
Muskegon, Michigan, United States
Michiana Hematology Oncology PC - Niles
Niles, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, United States
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Metro Health Hospital
Wyoming, Michigan, United States
Saint Luke's Hospital
Chesterfield, Missouri, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, United States
St. Anthony's Cancer Center
St Louis, Missouri, United States
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
Grand Island, Nebraska, United States
Callahan Cancer Center at Great Plains Regional Medical Center
North Platte, Nebraska, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
Concord, New Hampshire, United States
Center for Cancer Care at Exeter Hospital
Exeter, New Hampshire, United States
New Hampshire Oncology - Hematology, PA - Hooksett
Hooksett, New Hampshire, United States
Lakes Region General Hospital
Laconia, New Hampshire, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Norris Cotton Cancer Center at Catholic Medical Center
Manchester, New Hampshire, United States
Elliot Regional Cancer Center at Elliot Hospital
Manchester, New Hampshire, United States
Foundation Medical Partners
Nashua, New Hampshire, United States
Oncology Center at St. Joseph Hospital
Nashua, New Hampshire, United States
St. Barnabas Medical Center Cancer Center
Livingston, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Lipson Cancer and Blood Center at Rochester General Hospital
Rochester, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Cape Fear Valley Medical Center Cancer Center
Fayetteville, North Carolina, United States
Maria Parham Medical Center
Henderson, North Carolina, United States
Southeastern Regional Medical Center
Lumberton, North Carolina, United States
Granville Medical Center
Oxford, North Carolina, United States
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, United States
Duke Health Raleigh Hospital
Raleigh, North Carolina, United States
Person Memorial Hospital
Roxboro, North Carolina, United States
Marion L. Shepard Cancer Center at Beaufort County Hospital
Washington, North Carolina, United States
Keyserling Cancer Center at Beaufort Memorial Hospital
Beaufort, South Carolina, United States
South Carolina Oncology Associates, PA
Columbia, South Carolina, United States
Coastal Cancer Center - Myrtle Beach
Myrtle Beach, South Carolina, United States
Mountainview Medical
Berlin Corners, Vermont, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States
Medical Oncology and Hematology Associates of North Virginia - Fairfax
Fairfax, Virginia, United States
St. Mary's Regional Cancer Center at St. Mary's Medical Center
Huntington, West Virginia, United States
Countries
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References
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Mandelblatt JS, Faul LA, Luta G, Makgoeng SB, Isaacs C, Taylor K, Sheppard VB, Tallarico M, Barry WT, Cohen HJ. Patient and physician decision styles and breast cancer chemotherapy use in older women: Cancer and Leukemia Group B protocol 369901. J Clin Oncol. 2012 Jul 20;30(21):2609-14. doi: 10.1200/JCO.2011.40.2909. Epub 2012 May 21.
Mandelblatt JS, Sheppard VB, Hurria A, Kimmick G, Isaacs C, Taylor KL, Kornblith AB, Noone AM, Luta G, Tallarico M, Barry WT, Hunegs L, Zon R, Naughton M, Winer E, Hudis C, Edge SB, Cohen HJ, Muss H; Cancer Leukemia Group B. Breast cancer adjuvant chemotherapy decisions in older women: the role of patient preference and interactions with physicians. J Clin Oncol. 2010 Jul 1;28(19):3146-53. doi: 10.1200/JCO.2009.24.3295. Epub 2010 Jun 1.
Mandelblatt J, Sheppard V, Hurria A, et al.: Patient preference as a determinant of breast cancer adjuvant chemotherapy use in older women: CALGB #369901. [Abstract] J Clin Oncol 27 (Suppl 15): A-9544, 2009.
Kreling B, Figueiredo MI, Sheppard VL, Mandelblatt JS. A qualitative study of factors affecting chemotherapy use in older women with breast cancer: barriers, promoters, and implications for intervention. Psychooncology. 2006 Dec;15(12):1065-76. doi: 10.1002/pon.1042.
Bluethmann SM, Alfano CM, Clapp JD, Luta G, Small BJ, Hurria A, Cohen HJ, Sugarman S, B Muss H, Isaacs C, Mandelblatt JS. Cognitive function and discontinuation of adjuvant hormonal therapy in older breast cancer survivors: CALGB 369901 (Alliance). Breast Cancer Res Treat. 2017 Oct;165(3):677-686. doi: 10.1007/s10549-017-4353-y. Epub 2017 Jun 26.
Mandelblatt JS, Cai L, Luta G, Kimmick G, Clapp J, Isaacs C, Pitcher B, Barry W, Winer E, Sugarman S, Hudis C, Muss H, Cohen HJ, Hurria A. Frailty and long-term mortality of older breast cancer patients: CALGB 369901 (Alliance). Breast Cancer Res Treat. 2017 Jul;164(1):107-117. doi: 10.1007/s10549-017-4222-8. Epub 2017 Mar 31.
Other Identifiers
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CALGB-369901
Identifier Type: -
Identifier Source: secondary_id
CDR0000321396
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-369901
Identifier Type: -
Identifier Source: org_study_id
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