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Clinical Trial Questions?
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Study of Chemotherapy Decisions and Outcomes in Women Age 65 and Over With Operable, Newly Diagnosed Breast Cancer
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information
Alternate Title
Chemotherapy Decisions and Outcomes in Older Women With Newly Diagnosed Breast Cancer
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| No phase specified | Educational/Counseling/Training | Active | 65 and over | CALGB-369901
NCT00068328 |
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.
Entry 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
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy Endocrine therapy Radiotherapy Surgery Patient Characteristics:
Age Sex Menopausal status Performance status Life expectancy Hematopoietic Hepatic Renal 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
Expected Enrollment 1360A total of 1,296 patients will be accrued for this study within 18-24 months. 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. Published ResultsMandelblatt 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, et al.: A qualitative study of factors affecting chemotherapy use in older women with breast cancer: barriers, promoters, and implications for intervention. Psychooncology 15 (12): 1065-76, 2006.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations Cancer and Leukemia Group B | | | | Jeanne Mandelblatt, MD, MPH, Protocol chair | | | | | Alice Kornblith, PhD, Protocol co-chair | | | Ph: 617-632-2640; 866-790-4500 |
| | | Hyman Muss, MD, Protocol co-chair | | | | | Stephen Edge, MD, Protocol co-chair | | | Ph: 716-845-2918; 800-685-6825 |
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Trial Sites
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| U.S.A. |
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| California |
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Arroyo Grande |
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| | | | | | | | | Arroyo Grande Community Hospital |
| | | David Palchak, MD | |
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Pismo Beach |
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| | | David Palchak, MD | |
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| District of Columbia |
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Washington |
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| | | | Walter Reed Army Medical Center |
| | | Clinical Trials Office - Walter Reed Army Medical Center | |
| | | Washington Cancer Institute at Washington Hospital Center |
| | | Clinical Trials Office - Washington Cancer Institute | |
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| Illinois |
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Chicago |
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| | | | University of Chicago Cancer Research Center |
| | | Clinical Trials Office - University of Chicago Cancer Research Center | |
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La Grange |
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| | | La Grange Memorial Hospital |
| | | Clinical Trials Office - La Grange Memorial Hospital | |
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Rockford |
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| | | Center for Cancer Care at OSF Saint Anthony Medical Center |
| | | Clinical Trials Office - Center for Cancer Care at OSF Saint Anthony Medical Center | |
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| Indiana |
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Elkhart |
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| | | | Elkhart General Hospital |
| | | Rafat Ansari, MD, FACP | |
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Kokomo |
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| | | Howard Community Hospital |
| | | Rafat Ansari, MD, FACP | |
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La Porte |
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| | | Center for Cancer Therapy at LaPorte Hospital and Health Services |
| | | Rafat Ansari, MD, FACP | |
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Merrillville |
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| | | Suniti Medical Corporation |
| | | Bharat Barai, MD | |
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South Bend |
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| | | CCOP - Northern Indiana CR Consortium |
| | | Rafat Ansari, MD, FACP | |
| | | Memorial Hospital of South Bend |
| | | Clinical Trials Office - Memorial Hospital of South Bend | |
| | | Saint Joseph Regional Medical Center |
| | | Rafat Ansari, MD, FACP | |
| | | South Bend Clinic |
| | | Rafat Ansari, MD, FACP | |
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| Maine |
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Scarborough |
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| | | | Maine Center for Cancer Medicine and Blood Disorders - Scarborough |
| | | Tracey Weisberg, MD | |
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| Maryland |
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Baltimore |
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| | | | Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center |
| | | Clinical Trials Office - Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center | |
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| Massachusetts |
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Attleboro |
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| | | | Sturdy Memorial Hospital |
| | | Michael Vasconcelles, MD | |
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Boston |
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| | | Dana-Farber/Brigham and Women's Cancer Center |
| | | Clinical Trials Office | |
| | | Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute |
| | | Contact Person | | Ph: | 617-632-3474 | | 866-790-4500 |
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| | | Massachusetts General Hospital |
| | | Clinical Trials Office - Massachusetts General Hospital | |
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Gloucester |
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| | | Addison Gilbert Hospital |
| | | Angus McIntyre, MD | |
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Hyannis |
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| | | Cape Cod Hospital |
| | | Contact Person | |
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Lowell |
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| | | Lowell General Hospital |
| | | Contact Person | |
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South Weymouth |
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| | | South Shore Hospital |
| | | Contact Person | |
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| Michigan |
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Battle Creek |
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| | | | Battle Creek Health System Cancer Care Center |
| | | Martin Bury | |
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Big Rapids |
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| | | Mecosta County Medical Center |
| | | Martin Bury | |
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Grand Rapids |
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| | | Butterworth Hospital at Spectrum Health |
| | | Martin Bury | |
| | | CCOP - Grand Rapids |
| | | Martin Bury | |
| | | Lacks Cancer Center at Saint Mary's Health Care |
| | | Martin Bury | |
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Muskegon |
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| | | Mercy General Health Partners |
| | | Martin Bury | |
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St. Joseph |
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| | | Lakeland Regional Cancer Care Center - St. Joseph |
| | | Rafat Ansari, MD, FACP | |
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Traverse City |
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| | | Munson Medical Center |
| | | Martin Bury | |
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Wyoming |
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| | | Metro Health Hospital |
| | | Martin Bury | |
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| Missouri |
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Chesterfield |
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| | | | Saint Luke's Hospital |
| | | Donald Busiek, MD | |
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Columbia |
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| | | Ellis Fischel Cancer Center at University of Missouri - Columbia |
| | | Clinical Trial Office - Ellis Fischel Cancer Center | |
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Saint Louis |
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| | | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
| | | Michael Naughton, MD | |
| | | St. Anthony's Cancer Center |
| | | R. William Morris, MD | |
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| Nebraska |
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Grand Island |
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| | | | Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center |
| | | Elizabeth Reed, MD | |
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North Platte |
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| | | Callahan Cancer Center at Great Plains Regional Medical Center |
| | | Clinical Trials Office - Callahan Cancer Center at Great Plains Regional Medical Center | |
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Omaha |
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| | | UNMC Eppley Cancer Center at the University of Nebraska Medical Center |
| | | Clinical Trials Office - UNMC Eppley Cancer Center at the University of Nebraska Medical Center | |
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| Nevada |
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Las Vegas |
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| | | | CCOP - Nevada Cancer Research Foundation |
| | | John Ellerton, MD, CM | |
| | | University Medical Center of Southern Nevada |
| | | John Ellerton, MD, CM | |
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| New Hampshire |
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Concord |
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| | | | New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care |
| | | Frederick Briccetti, MD | |
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Exeter |
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| | | Center for Cancer Care at Exeter Hospital |
| | | Danny Sims | |
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Hooksett |
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| | | New Hampshire Oncology - Hematology, PA - Hooksett |
| | | Frederick Briccetti, MD | |
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Laconia |
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| | | Lakes Region General Hospital |
| | | Charles Catcher, MD | |
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Lebanon |
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| | | Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center |
| | | Clinical Trials Office - Norris Cotton Cancer Center | |
| | Email:
cancerhelp@dartmouth.edu |
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Manchester |
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| | | Elliot Regional Cancer Center at Elliot Hospital |
| | | Douglas Weckstein, MD | |
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Nashua |
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| | | Oncology Center at St. Joseph Hospital |
| | | Mary Ann Voltz, MD | |
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| New Jersey |
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Livingston |
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| | | | St. Barnabas Medical Center Cancer Center |
| | | Clinical Trials Office - St. Barnabas Medical Center Cancer Center | |
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| New York |
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Buffalo |
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| | | | Roswell Park Cancer Institute |
| | | Clinical Trials Office - Roswell Park Cancer Institute | |
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East Syracuse |
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| | | CCOP - Hematology-Oncology Associates of Central New York |
| | | Jeffrey Kirshner, MD | |
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New York |
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| | | Memorial Sloan-Kettering Cancer Center |
| | | Diana Lake, MD | |
| | | Ralph Lauren Center for Cancer Care and Prevention |
| | | Diana Lake, MD | |
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Rochester |
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| | | Lipson Cancer and Blood Center at Rochester General Hospital |
| | | Peter Bushunow, MD | |
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| North Carolina |
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Durham |
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| | | | Duke Comprehensive Cancer Center |
| | | Clinical Trials Office - Duke Comprehensive Cancer Center | |
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Fayetteville |
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| | | Cape Fear Valley Medical Center Cancer Center |
| | | Clinical Trial Office - Cape Fear Valley Medical Center Cancer Center | |
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Henderson |
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| | | Maria Parham Medical Center |
| | | Jeffrey Crawford, MD | |
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Lumberton |
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| | | Southeastern Regional Medical Center |
| | | Jeffrey Crawford, MD | |
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Oxford |
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| | | Granville Medical Center |
| | | Jeffrey Crawford, MD | |
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Pinehurst |
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| | | FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center |
| | | Clinical Trials Office - FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center | |
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Raleigh |
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| | | Duke Health Raleigh Hospital |
| | | Jeffrey Crawford, MD | |
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Roxboro |
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| | | Person Memorial Hospital |
| | | Jeffrey Crawford, MD | |
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Winston-Salem |
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| | | Wake Forest University Comprehensive Cancer Center |
| | | Clinical Trials Office - Wake Forest University Comprehensive Cancer Center | |
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| South Carolina |
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Beaufort |
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| | | | Keyserling Cancer Center at Beaufort Memorial Hospital |
| | | Majd Chahin | | Ph: | 877-532-6472 | | 888-522-5585 |
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Columbia |
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| | | South Carolina Oncology Associates, PA |
| | | George Jones | |
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| Vermont |
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Berlin |
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| | | | Mountainview Medical |
| | | Hyman Muss, MD | |
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Burlington |
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| | | Fletcher Allen Health Care - University Health Center Campus |
| | | Clinical Trials Office - Fletcher Allen Health Care | |
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| West Virginia |
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Huntington |
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| | | | St. Mary's Regional Cancer Center at St. Mary's Medical Center |
| | | Gerrit Kimmey, MD | |
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| Registry Information | | | Official Title | | Observational Cohort Study: Chemotherapy Decisions and Outcomes in Women Age 65 or Older with Operable, Newly Diagnosed Breast Cancer | | | Trial Start Date | | 2003-08-01 | | | Trial Completion Date | | 2005-07-21 (estimated) | | | Registered in ClinicalTrials.gov | | NCT00068328 | | | Date Submitted to PDQ | | 2003-07-14 | | | Information Last Verified | | 2009-11-15 | | | NCI Grant/Contract Number | | CA84131 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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