Chemotherapy Decisions and Outcomes in Older Women With Newly Diagnosed Breast Cancer
- Conditions
- Psychosocial Effects of Cancer and Its TreatmentBreast Cancer
- Interventions
- Procedure: psychosocial assessment and careProcedure: quality-of-life assessment
- Registration Number
- NCT00068328
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1706
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 quality-of-life assessment 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. Group 1 psychosocial assessment and care 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.
- Primary Outcome Measures
Name Time Method quality of life Up to 5 years
- Secondary Outcome Measures
Name Time Method disease free survival Up to 5 years mortality rate Up to 5 years
Trial Locations
- Locations (84)
Elkhart Clinic, LLC
🇺🇸Elkhart, Indiana, United States
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
🇺🇸Pinehurst, North Carolina, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
Suniti Medical Corporation
🇺🇸Merrillville, Indiana, United States
Saint Luke's Hospital
🇺🇸Chesterfield, Missouri, United States
Southeastern Regional Medical Center
🇺🇸Lumberton, North Carolina, 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
Louis A. Weiss Memorial Hospital
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Camino Medical Group - Treatment Center
🇺🇸Mountain View, California, United States
Bendheim Cancer Center at Greenwich Hospital
🇺🇸Greenwich, Connecticut, United States
Michiana Hematology-Oncology, PC - Elkhart
🇺🇸Elkhart, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
🇺🇸La Porte, 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 - South Bend
🇺🇸Mishawaka, Indiana, United States
Michiana Hematology Oncology PC - Plymouth
🇺🇸Plymouth, Indiana, United States
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
🇺🇸Scarborough, Maine, United States
Addison Gilbert Hospital
🇺🇸Gloucester, Massachusetts, United States
Lowell General Hospital
🇺🇸Lowell, Massachusetts, United States
Lacks Cancer Center at Saint Mary's Health Care
🇺🇸Grand Rapids, Michigan, United States
Metro Health Hospital
🇺🇸Wyoming, Michigan, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
Mercy General Health Partners
🇺🇸Muskegon, Michigan, United States
Lakeside Cancer Specialists, PLLC
🇺🇸Saint Joseph, Michigan, United States
University Medical Center of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
🇺🇸Grand Island, Nebraska, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
🇺🇸Saint Louis, Missouri, United States
Lipson Cancer and Blood Center at Rochester General Hospital
🇺🇸Rochester, New York, United States
Maria Parham Medical Center
🇺🇸Henderson, 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
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Michiana Hematology Oncology PC - Niles
🇺🇸Niles, Michigan, United States
Palo Alto Medical Foundation
🇺🇸Palo Alto, California, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Walter Reed Army Medical Center
🇺🇸Washington, D.C., District of Columbia, United States
Washington Cancer Institute at Washington Hospital Center
🇺🇸Washington, D.C., District of Columbia, United States
Cancer Center of South Florida Foundation, Incorporated
🇺🇸Lake Worth, Florida, 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
Howard Community Hospital
🇺🇸Kokomo, Indiana, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Saint Joseph Regional Medical Center
🇺🇸Mishawaka, Indiana, United States
Dana-Farber/Brigham and Women's Cancer Center
🇺🇸Boston, Massachusetts, United States
Sturdy Memorial Hospital
🇺🇸Attleboro, Massachusetts, United States
Michiana Hematology Oncology PC - La Porte
🇺🇸Westville, Indiana, United States
Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
🇺🇸Baltimore, Maryland, United States
Cape Cod Hospital
🇺🇸Hyannis, Massachusetts, United States
Battle Creek Health System Cancer Care Center
🇺🇸Battle Creek, Michigan, United States
Butterworth Hospital at Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
Mecosta County Medical Center
🇺🇸Big Rapids, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph
🇺🇸Saint Joseph, Michigan, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
🇺🇸Concord, New Hampshire, United States
St. Anthony's Cancer Center
🇺🇸Saint Louis, Missouri, United States
CCOP - Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
New Hampshire Oncology - Hematology, PA - Hooksett
🇺🇸Hooksett, New Hampshire, United States
Center for Cancer Care at Exeter Hospital
🇺🇸Exeter, 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
Foundation Medical Partners
🇺🇸Nashua, New Hampshire, United States
Oncology Center at St. Joseph Hospital
🇺🇸Nashua, 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
CCOP - Hematology-Oncology Associates of Central New York
🇺🇸East Syracuse, New York, United States
St. Barnabas Medical Center Cancer Center
🇺🇸Livingston, New Jersey, United States
Queens Cancer Center of Queens Hospital
🇺🇸Jamaica, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Cape Fear Valley Medical Center Cancer Center
🇺🇸Fayetteville, North Carolina, United States
Mountainview Medical
🇺🇸Berlin Corners, Vermont, United States
Granville Medical Center
🇺🇸Oxford, North Carolina, United States
Coastal Cancer Center - Myrtle Beach
🇺🇸Myrtle Beach, South Carolina, United States
South Carolina Oncology Associates, PA
🇺🇸Columbia, South Carolina, United States
Duke Health Raleigh Hospital
🇺🇸Raleigh, North Carolina, United States
St. Mary's Regional Cancer Center at St. Mary's Medical Center
🇺🇸Huntington, West Virginia, United States
Callahan Cancer Center at Great Plains Regional Medical Center
🇺🇸North Platte, Nebraska, United States
Person Memorial Hospital
🇺🇸Roxboro, North Carolina, United States