Breast Cancer Clinical Trial

Chemotherapy Decisions and Outcomes in Older Women With Newly Diagnosed Breast Cancer

Summary

RATIONALE: Studying how older women make treatment decisions and how these decisions affect the outcome of treatment may help doctors plan more effective treatments and improve patient quality of life.

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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Full Description

OBJECTIVES:

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.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

1706

Study ID:

NCT00068328

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 77 Locations for this study

See Locations Near You

Camino Medical Group - Treatment Center
Mountain View California, 94040, United States
Palo Alto Medical Foundation
Palo Alto California, 94301, United States

Pismo Beach California, 93449, United States
Bendheim Cancer Center at Greenwich Hospital
Greenwich Connecticut, 06830, United States
Washington Cancer Institute at Washington Hospital Center
Washington, D.C. District of Columbia, 20010, United States
Walter Reed Army Medical Center
Washington, D.C. District of Columbia, 20307, United States
Cancer Center of South Florida Foundation, Incorporated
Lake Worth Florida, 33461, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
Louis A. Weiss Memorial Hospital
Chicago Illinois, 60640, United States
La Grange Memorial Hospital
La Grange Illinois, 60525, United States
Center for Cancer Care at OSF Saint Anthony Medical Center
Rockford Illinois, 61108, United States
Elkhart Clinic, LLC
Elkhart Indiana, 46514, United States
Michiana Hematology-Oncology, PC - Elkhart
Elkhart Indiana, 46514, United States
Elkhart General Hospital
Elkhart Indiana, 46515, United States
Howard Community Hospital
Kokomo Indiana, 46904, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte Indiana, 46350, United States
Suniti Medical Corporation
Merrillville Indiana, 46410, United States
Michiana Hematology-Oncology, PC - South Bend
Mishawaka Indiana, 46545, United States
Saint Joseph Regional Medical Center
Mishawaka Indiana, 46545, United States
Michiana Hematology Oncology PC - Plymouth
Plymouth Indiana, 46563, United States
CCOP - Northern Indiana CR Consortium
South Bend Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend Indiana, 46601, United States
South Bend Clinic
South Bend Indiana, 46617, United States
Michiana Hematology Oncology PC - La Porte
Westville Indiana, 46391, United States
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough Maine, 04074, United States
Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
Baltimore Maryland, 21237, United States
Sturdy Memorial Hospital
Attleboro Massachusetts, 02703, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Dana-Farber/Brigham and Women's Cancer Center
Boston Massachusetts, 02115, United States
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston Massachusetts, 02115, United States
Addison Gilbert Hospital
Gloucester Massachusetts, 01930, United States
Cape Cod Hospital
Hyannis Massachusetts, 02601, United States
Lowell General Hospital
Lowell Massachusetts, 01854, United States
Battle Creek Health System Cancer Care Center
Battle Creek Michigan, 49017, United States
Mecosta County Medical Center
Big Rapids Michigan, 49307, United States
Butterworth Hospital at Spectrum Health
Grand Rapids Michigan, 49503, United States
CCOP - Grand Rapids
Grand Rapids Michigan, 49503, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids Michigan, 49503, United States
Mercy General Health Partners
Muskegon Michigan, 49443, United States
Michiana Hematology Oncology PC - Niles
Niles Michigan, 49120, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph Michigan, 49085, United States
Lakeside Cancer Specialists, PLLC
Saint Joseph Michigan, 49085, United States
Munson Medical Center
Traverse City Michigan, 49684, United States
Metro Health Hospital
Wyoming Michigan, 49519, United States
Saint Luke's Hospital
Chesterfield Missouri, 63017, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia Missouri, 65203, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis Missouri, 63110, United States
St. Anthony's Cancer Center
Saint Louis Missouri, 63128, United States
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
Grand Island Nebraska, 68803, United States
Callahan Cancer Center at Great Plains Regional Medical Center
North Platte Nebraska, 69103, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
University Medical Center of Southern Nevada
Las Vegas Nevada, 89102, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
Concord New Hampshire, 03301, United States
Center for Cancer Care at Exeter Hospital
Exeter New Hampshire, 03833, United States
New Hampshire Oncology - Hematology, PA - Hooksett
Hooksett New Hampshire, 03106, United States
Lakes Region General Hospital
Laconia New Hampshire, 03246, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Norris Cotton Cancer Center at Catholic Medical Center
Manchester New Hampshire, 03102, United States
Elliot Regional Cancer Center at Elliot Hospital
Manchester New Hampshire, 03103, United States
Foundation Medical Partners
Nashua New Hampshire, 03060, United States
Oncology Center at St. Joseph Hospital
Nashua New Hampshire, 03060, United States
St. Barnabas Medical Center Cancer Center
Livingston New Jersey, 07039, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse New York, 13057, United States
Queens Cancer Center of Queens Hospital
Jamaica New York, 11432, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States
Lipson Cancer and Blood Center at Rochester General Hospital
Rochester New York, 14621, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill North Carolina, 27599, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
Cape Fear Valley Medical Center Cancer Center
Fayetteville North Carolina, 28302, United States
Maria Parham Medical Center
Henderson North Carolina, 27536, United States
Southeastern Regional Medical Center
Lumberton North Carolina, 28359, United States
Granville Medical Center
Oxford North Carolina, 27565, United States
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst North Carolina, 28374, United States
Duke Health Raleigh Hospital
Raleigh North Carolina, 27609, United States
Person Memorial Hospital
Roxboro North Carolina, 27573, United States
Marion L. Shepard Cancer Center at Beaufort County Hospital
Washington North Carolina, 27889, United States
Keyserling Cancer Center at Beaufort Memorial Hospital
Beaufort South Carolina, 29902, United States
South Carolina Oncology Associates, PA
Columbia South Carolina, 29210, United States
Coastal Cancer Center - Myrtle Beach
Myrtle Beach South Carolina, 29572, United States
Mountainview Medical
Berlin Corners Vermont, 05602, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington Vermont, 05401, United States
Medical Oncology and Hematology Associates of North Virginia - Fairfax
Fairfax Virginia, 22031, United States
St. Mary's Regional Cancer Center at St. Mary's Medical Center
Huntington West Virginia, 25702, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

1706

Study ID:

NCT00068328

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

How clear is this clinincal trial information?

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