Chemotherapy Decisions and Outcomes in Older Women With Newly Diagnosed Breast Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Cancer and Leukemia Group B
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00068328
First received: September 10, 2003
Last updated: February 18, 2011
Last verified: February 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer Psychosocial Effects of Cancer and Its Treatment |
Procedure: psychosocial assessment and care Procedure: quality-of-life assessment |
| Study Type: | Interventional |
| Official Title: | Observational Cohort Study: Chemotherapy Decisions and Outcomes in Women Age 65 or Older With Operable, Newly Diagnosed Breast Cancer |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Estimated Enrollment: | 1360 |
| Study Start Date: | August 2003 |
| Estimated Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Menopausal status
- Not specified
Performance status
- Any performance status
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
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
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00068328
Hide Study Locations
Hide Study LocationsLocations
| United States, California | |
| Camino Medical Group - Treatment Center | |
| Mountain View, California, United States, 94040 | |
| Palo Alto Medical Foundation | |
| Palo Alto, California, United States, 94301 | |
| Pismo Beach, California, United States, 93449 | |
| United States, Connecticut | |
| Bendheim Cancer Center at Greenwich Hospital | |
| Greenwich, Connecticut, United States, 06830 | |
| United States, District of Columbia | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307-5001 | |
| Washington Cancer Institute at Washington Hospital Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Cancer Center of South Florida Foundation, Incorporated | |
| Lake Worth, Florida, United States, 33461 | |
| United States, Illinois | |
| Louis A. Weiss Memorial Hospital | |
| Chicago, Illinois, United States, 60640 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| La Grange Memorial Hospital | |
| La Grange, Illinois, United States, 60525 | |
| Center for Cancer Care at OSF Saint Anthony Medical Center | |
| Rockford, Illinois, United States, 61108 | |
| United States, Indiana | |
| Michiana Hematology-Oncology, PC - Elkhart | |
| Elkhart, Indiana, United States, 46514 | |
| Elkhart General Hospital | |
| Elkhart, Indiana, United States, 46515 | |
| Elkhart Clinic, LLC | |
| Elkhart, Indiana, United States, 46514-2098 | |
| Howard Community Hospital | |
| Kokomo, Indiana, United States, 46904 | |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | |
| La Porte, Indiana, United States, 46350 | |
| Suniti Medical Corporation | |
| Merrillville, Indiana, United States, 46410 | |
| Michiana Hematology-Oncology, PC - South Bend | |
| Mishawaka, Indiana, United States, 46545-1470 | |
| Saint Joseph Regional Medical Center | |
| Mishawaka, Indiana, United States, 46545-1470 | |
| Michiana Hematology Oncology PC - Plymouth | |
| Plymouth, Indiana, United States, 46563 | |
| South Bend Clinic | |
| South Bend, Indiana, United States, 46617 | |
| Memorial Hospital of South Bend | |
| South Bend, Indiana, United States, 46601 | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| Michiana Hematology Oncology PC - La Porte | |
| Westville, Indiana, United States, 46391 | |
| United States, Maine | |
| Maine Center for Cancer Medicine and Blood Disorders - Scarborough | |
| Scarborough, Maine, United States, 04074 | |
| United States, Maryland | |
| Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center | |
| Baltimore, Maryland, United States, 21237 | |
| United States, Massachusetts | |
| Sturdy Memorial Hospital | |
| Attleboro, Massachusetts, United States, 02703 | |
| Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Dana-Farber/Brigham and Women's Cancer Center | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Addison Gilbert Hospital | |
| Gloucester, Massachusetts, United States, 01930 | |
| Cape Cod Hospital | |
| Hyannis, Massachusetts, United States, 02601 | |
| Lowell General Hospital | |
| Lowell, Massachusetts, United States, 01854 | |
| United States, Michigan | |
| Battle Creek Health System Cancer Care Center | |
| Battle Creek, Michigan, United States, 49017 | |
| Mecosta County Medical Center | |
| Big Rapids, Michigan, United States, 49307 | |
| CCOP - Grand Rapids | |
| Grand Rapids, Michigan, United States, 49503 | |
| Lacks Cancer Center at Saint Mary's Health Care | |
| Grand Rapids, Michigan, United States, 49503 | |
| Butterworth Hospital at Spectrum Health | |
| Grand Rapids, Michigan, United States, 49503 | |
| Mercy General Health Partners | |
| Muskegon, Michigan, United States, 49443 | |
| Michiana Hematology Oncology PC - Niles | |
| Niles, Michigan, United States, 49120 | |
| Lakeside Cancer Specialists, PLLC | |
| Saint Joseph, Michigan, United States, 49085 | |
| Lakeland Regional Cancer Care Center - St. Joseph | |
| St. Joseph, Michigan, United States, 49085 | |
| Munson Medical Center | |
| Traverse City, Michigan, United States, 49684 | |
| Metro Health Hospital | |
| Wyoming, Michigan, United States, 49519 | |
| United States, Missouri | |
| Saint Luke's Hospital | |
| Chesterfield, Missouri, United States, 63017 | |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | |
| Saint Louis, Missouri, United States, 63110 | |
| St. Anthony's Cancer Center | |
| Saint Louis, Missouri, United States, 63128 | |
| United States, Nebraska | |
| Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center | |
| Grand Island, Nebraska, United States, 68803 | |
| Callahan Cancer Center at Great Plains Regional Medical Center | |
| North Platte, Nebraska, United States, 69103 | |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-6805 | |
| United States, Nevada | |
| CCOP - Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| University Medical Center of Southern Nevada | |
| Las Vegas, Nevada, United States, 89102 | |
| United States, New Hampshire | |
| New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care | |
| Concord, New Hampshire, United States, 03301 | |
| Center for Cancer Care at Exeter Hospital | |
| Exeter, New Hampshire, United States, 03833 | |
| New Hampshire Oncology - Hematology, PA - Hooksett | |
| Hooksett, New Hampshire, United States, 03106 | |
| Lakes Region General Hospital | |
| Laconia, New Hampshire, United States, 03246 | |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| Elliot Regional Cancer Center at Elliot Hospital | |
| Manchester, New Hampshire, United States, 03103 | |
| Norris Cotton Cancer Center at Catholic Medical Center | |
| Manchester, New Hampshire, United States, 03102 | |
| Foundation Medical Partners | |
| Nashua, New Hampshire, United States, 03060 | |
| Oncology Center at St. Joseph Hospital | |
| Nashua, New Hampshire, United States, 03060 | |
| United States, New Jersey | |
| St. Barnabas Medical Center Cancer Center | |
| Livingston, New Jersey, United States, 07039 | |
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| CCOP - Hematology-Oncology Associates of Central New York | |
| East Syracuse, New York, United States, 13057 | |
| Queens Cancer Center of Queens Hospital | |
| Jamaica, New York, United States, 11432 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| Lipson Cancer and Blood Center at Rochester General Hospital | |
| Rochester, New York, United States, 14621 | |
| United States, North Carolina | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Cape Fear Valley Medical Center Cancer Center | |
| Fayetteville, North Carolina, United States, 28302-2000 | |
| Maria Parham Medical Center | |
| Henderson, North Carolina, United States, 27536 | |
| Southeastern Regional Medical Center | |
| Lumberton, North Carolina, United States, 28359 | |
| Granville Medical Center | |
| Oxford, North Carolina, United States, 27565 | |
| FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center | |
| Pinehurst, North Carolina, United States, 28374 | |
| Duke Health Raleigh Hospital | |
| Raleigh, North Carolina, United States, 27609 | |
| Person Memorial Hospital | |
| Roxboro, North Carolina, United States, 27573 | |
| Marion L. Shepard Cancer Center at Beaufort County Hospital | |
| Washington, North Carolina, United States, 27889 | |
| United States, South Carolina | |
| Keyserling Cancer Center at Beaufort Memorial Hospital | |
| Beaufort, South Carolina, United States, 29902 | |
| South Carolina Oncology Associates, PA | |
| Columbia, South Carolina, United States, 29210 | |
| Coastal Cancer Center - Myrtle Beach | |
| Myrtle Beach, South Carolina, United States, 29572 | |
| United States, Vermont | |
| Mountainview Medical | |
| Berlin, Vermont, United States, 05602 | |
| Fletcher Allen Health Care - University Health Center Campus | |
| Burlington, Vermont, United States, 05401 | |
| United States, Virginia | |
| Medical Oncology and Hematology Associates of North Virginia - Fairfax | |
| Fairfax, Virginia, United States, 22031 | |
| United States, West Virginia | |
| St. Mary's Regional Cancer Center at St. Mary's Medical Center | |
| Huntington, West Virginia, United States, 25702 | |
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
| Study Chair: | Jeanne Mandelblatt, MD, MPH | Lombardi Cancer Research Center |
| Investigator: | Alice B. Kornblith, PhD | Dana-Farber Cancer Institute |
| Investigator: | Hyman B. Muss, MD | University of Vermont |
| Investigator: | Stephen B. Edge, MD | Roswell Park Cancer Institute |
More Information
Additional Information:
Publications:
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.
| ClinicalTrials.gov Identifier: | NCT00068328 History of Changes |
| Other Study ID Numbers: | CDR0000321396, CALGB-369901 |
| Study First Received: | September 10, 2003 |
| Last Updated: | February 18, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
psychosocial effects of cancer and its treatment stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
stage IA breast cancer stage IB breast cancer estrogen receptor-negative breast cancer estrogen receptor-positive breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 21, 2013