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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00068328 |
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 |
| Estimated Enrollment: | 1360 |
| Study Start Date: | August 2003 |
| Estimated Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed primary adenocarcinoma of the breast
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations
Hide Study Locations| United States, California | |
| Arroyo Grande Community Hospital | Recruiting |
| Arroyo Grande, California, United States, 93420 | |
| Contact: David L. Palchak, MD 805-773-7127 | |
| Recruiting | |
| Pismo Beach, California, United States, 93449 | |
| Contact: David L. Palchak, MD 805-773-7127 | |
| United States, District of Columbia | |
| Walter Reed Army Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20307-5001 | |
| Contact: Clinical Trials Office - Walter Reed Army Medical Center 202-782-7840 | |
| Washington Cancer Institute at Washington Hospital Center | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| Contact: Clinical Trials Office - Washington Cancer Institute 202-877-8839 | |
| United States, Illinois | |
| Center for Cancer Care at OSF Saint Anthony Medical Center | Recruiting |
| Rockford, Illinois, United States, 61108 | |
| Contact: Clinical Trials Office - Center for Cancer Care at OSF Saint 815-227-2633 | |
| La Grange Memorial Hospital | Recruiting |
| La Grange, Illinois, United States, 60525 | |
| Contact: Clinical Trials Office - La Grange Memorial Hospital 630-856-7526 | |
| University of Chicago Cancer Research Center | Recruiting |
| Chicago, Illinois, United States, 60637-1470 | |
| Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 | |
| United States, Indiana | |
| CCOP - Northern Indiana CR Consortium | Recruiting |
| South Bend, Indiana, United States, 46601 | |
| Contact: Rafat H. Ansari, MD, FACP 574-234-5123 | |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | Recruiting |
| La Porte, Indiana, United States, 46350 | |
| Contact: Rafat H. Ansari, MD, FACP 574-234-5123 | |
| Elkhart General Hospital | Recruiting |
| Elkhart, Indiana, United States, 46515 | |
| Contact: Rafat H. Ansari, MD, FACP 574-234-5123 | |
| Howard Community Hospital | Recruiting |
| Kokomo, Indiana, United States, 46904 | |
| Contact: Rafat H. Ansari, MD, FACP 574-234-5123 | |
| Memorial Hospital of South Bend | Recruiting |
| South Bend, Indiana, United States, 46601 | |
| Contact: Clinical Trials Office - Memorial Hospital of South Bend 800-284-7370 | |
| Saint Joseph Regional Medical Center | Recruiting |
| South Bend, Indiana, United States, 46617 | |
| Contact: Rafat H. Ansari, MD, FACP 574-234-5123 | |
| South Bend Clinic | Recruiting |
| South Bend, Indiana, United States, 46617 | |
| Contact: Rafat H. Ansari, MD, FACP 574-234-5123 | |
| Suniti Medical Corporation | Recruiting |
| Merrillville, Indiana, United States, 46410 | |
| Contact: Bharat H. Barai, MD 219-736-2800 | |
| United States, Maine | |
| Maine Center for Cancer Medicine and Blood Disorders - Scarborough | Recruiting |
| Scarborough, Maine, United States, 04074 | |
| Contact: Tracey F. Weisberg, MD 207-885-7634 | |
| United States, Maryland | |
| Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center | Recruiting |
| Baltimore, Maryland, United States, 21237 | |
| Contact: Clinical Trials Office - Harry & Jeanette Weinberg Cancer Inst 443-777-7364 | |
| United States, Massachusetts | |
| Addison Gilbert Hospital | Recruiting |
| Gloucester, Massachusetts, United States, 01930 | |
| Contact: Angus P. McIntyre, MD 978-927-6850 | |
| Cape Cod Hospital | Recruiting |
| Hyannis, Massachusetts, United States, 02601 | |
| Contact: Contact Person 508-771-1800 | |
| Dana-Farber/Brigham and Women's Cancer Center | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Clinical Trials Office 617-724-5200 | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Contact Person 617-632-3474 | |
| Lowell General Hospital | Recruiting |
| Lowell, Massachusetts, United States, 01854 | |
| Contact: Contact Person 978-937-6000 | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130 | |
| South Shore Hospital | Recruiting |
| South Weymouth, Massachusetts, United States, 02190 | |
| Contact: Contact Person 781-340-8000 | |
| Sturdy Memorial Hospital | Recruiting |
| Attleboro, Massachusetts, United States, 02703 | |
| Contact: Michael J. Vasconcelles, MD 617-632-5301 | |
| United States, Michigan | |
| Battle Creek Health System Cancer Care Center | Recruiting |
| Battle Creek, Michigan, United States, 49017 | |
| Contact: Martin J. Bury 616-966-8000 | |
| Butterworth Hospital at Spectrum Health | Recruiting |
| Grand Rapids, Michigan, United States, 49503 | |
| Contact: Martin J. Bury 616-391-2799 | |
| CCOP - Grand Rapids | Recruiting |
| Grand Rapids, Michigan, United States, 49503 | |
| Contact: Martin J. Bury 616-391-1230 | |
| Lacks Cancer Center at Saint Mary's Health Care | Recruiting |
| Grand Rapids, Michigan, United States, 49503 | |
| Contact: Martin J. Bury 616-752-5222 | |
| Lakeland Regional Cancer Care Center - St. Joseph | Recruiting |
| St. Joseph, Michigan, United States, 49085 | |
| Contact: Rafat H. Ansari, MD, FACP 574-234-5123 | |
| Mecosta County Medical Center | Recruiting |
| Big Rapids, Michigan, United States, 49307 | |
| Contact: Martin J. Bury 231-796-8691 | |
| Mercy General Health Partners | Recruiting |
| Muskegon, Michigan, United States, 49443 | |
| Contact: Martin J. Bury 231-672-2000 | |
| Metro Health Hospital | Recruiting |
| Wyoming, Michigan, United States, 49519 | |
| Contact: Martin J. Bury 616-252-7200 | |
| Munson Medical Center | Recruiting |
| Traverse City, Michigan, United States, 49684 | |
| Contact: Martin J. Bury 231-935-6202 | |
| United States, Missouri | |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Recruiting |
| Columbia, Missouri, United States, 65203 | |
| Contact: Clinical Trial Office - Ellis Fischel Cancer Center 573-882-7440 | |
| Saint Luke's Hospital | Recruiting |
| Chesterfield, Missouri, United States, 63017 | |
| Contact: Donald F. Busiek, MD 314-205-6737 | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: Michael J. Naughton, MD 314-996-8872 | |
| St. Anthony's Cancer Center | Recruiting |
| Saint Louis, Missouri, United States, 63128 | |
| Contact: R. William Morris, MD 314-849-6066 | |
| United States, Nebraska | |
| Callahan Cancer Center at Great Plains Regional Medical Center | Recruiting |
| North Platte, Nebraska, United States, 69103 | |
| Contact: Clinical Trials Office - Callahan Cancer Center at Great Plain 308-696-7864 | |
| Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center | Recruiting |
| Grand Island, Nebraska, United States, 68803 | |
| Contact: Elizabeth C. Reed, MD 402-559-5388 | |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Recruiting |
| Omaha, Nebraska, United States, 68198-6805 | |
| Contact: Clinical Trials Office - UNMC Eppley Cancer Center at the Univ 800-999-5465 | |
| United States, Nevada | |
| CCOP - Nevada Cancer Research Foundation | Recruiting |
| Las Vegas, Nevada, United States, 89106 | |
| Contact: John A. Ellerton, MD, CM 702-384-0013 | |
| University Medical Center of Southern Nevada | Recruiting |
| Las Vegas, Nevada, United States, 89102 | |
| Contact: John A. Ellerton, MD, CM 702-384-0013 | |
| United States, New Hampshire | |
| Center for Cancer Care at Exeter Hospital | Recruiting |
| Exeter, New Hampshire, United States, 03833 | |
| Contact: Danny M. Sims 603-580-6636 | |
| Elliot Regional Cancer Center at Elliot Hospital | Recruiting |
| Manchester, New Hampshire, United States, 03103 | |
| Contact: Douglas J. Weckstein, MD 603-622-6484 | |
| Lakes Region General Hospital | Recruiting |
| Laconia, New Hampshire, United States, 03246 | |
| Contact: Charles H. Catcher, MD 603-224-2556 | |
| New Hampshire Oncology - Hematology, PA - Hooksett | Recruiting |
| Hooksett, New Hampshire, United States, 03106 | |
| Contact: Frederick M. Briccetti, MD 603-224-2556 | |
| New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care | Recruiting |
| Concord, New Hampshire, United States, 03301 | |
| Contact: Frederick M. Briccetti, MD 603-224-2556 | |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Recruiting |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| Contact: Clinical Trials Office - Norris Cotton Cancer Center 603-650-7609 cancerhelp@dartmouth.edu | |
| Oncology Center at St. Joseph Hospital | Recruiting |
| Nashua, New Hampshire, United States, 03060 | |
| Contact: Mary Ann Voltz, MD 603-880-3408 | |
| United States, New Jersey | |
| St. Barnabas Medical Center Cancer Center | Recruiting |
| Livingston, New Jersey, United States, 07039 | |
| Contact: Clinical Trials Office - St. Barnabas Medical Center Cancer Ce 973-322-2470 | |
| United States, New York | |
| CCOP - Hematology-Oncology Associates of Central New York | Recruiting |
| East Syracuse, New York, United States, 13057 | |
| Contact: Jeffrey J. Kirshner, MD 315-472-7504 | |
| Lipson Cancer and Blood Center at Rochester General Hospital | Recruiting |
| Rochester, New York, United States, 14621 | |
| Contact: Peter Bushunow, MD 585-922-4020 | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Diana E. Lake, MD 212-639-8953 | |
| Ralph Lauren Center for Cancer Care and Prevention | Recruiting |
| New York, New York, United States, 10035 | |
| Contact: Diana E. Lake, MD 212-639-8953 | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States, 14263-0001 | |
| Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724 | |
| United States, North Carolina | |
| Cape Fear Valley Medical Center Cancer Center | Recruiting |
| Fayetteville, North Carolina, United States, 28302-2000 | |
| Contact: Clinical Trial Office - Cape Fear Valley Medical Center Cance 910-609-4561 | |
| Duke Comprehensive Cancer Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Clinical Trials Office - Duke Comprehensive Cancer Center 888-275-3853 | |
| Maria Parham Medical Center | Recruiting |
| Henderson, North Carolina, United States, 27536 | |
| Contact: Jeffrey Crawford, MD 919-681-9509 | |
| FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center | Recruiting |
| Pinehurst, North Carolina, United States, 28374 | |
| Contact: Clinical Trials Office - FirstHealth Moore Regional Community 910-715-2200 | |
| Granville Medical Center | Recruiting |
| Oxford, North Carolina, United States, 27565 | |
| Contact: Jeffrey Crawford, MD 919-681-9509 | |
| Duke Health Raleigh Hospital | Recruiting |
| Raleigh, North Carolina, United States, 27609 | |
| Contact: Jeffrey Crawford, MD 919-681-9509 | |
| Person Memorial Hospital | Recruiting |
| Roxboro, North Carolina, United States, 27573 | |
| Contact: Jeffrey Crawford, MD 919-681-9509 | |
| Southeastern Regional Medical Center | Recruiting |
| Lumberton, North Carolina, United States, 28359 | |
| Contact: Jeffrey Crawford, MD 919-681-9509 | |
| Wake Forest University Comprehensive Cancer Center | Recruiting |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771 | |
| United States, South Carolina | |
| Keyserling Cancer Center at Beaufort Memorial Hospital | Recruiting |
| Beaufort, South Carolina, United States, 29902 | |
| Contact: Majd Chahin 877-532-6472 | |
| South Carolina Oncology Associates, PA | Recruiting |
| Columbia, South Carolina, United States, 29210 | |
| Contact: George T. Jones 803-461-3000 | |
| United States, Vermont | |
| Fletcher Allen Health Care - University Health Center Campus | Recruiting |
| Burlington, Vermont, United States, 05401 | |
| Contact: Clinical Trials Office - Fletcher Allen Health Care 802-656-8990 | |
| Mountainview Medical | Recruiting |
| Berlin, Vermont, United States, 05602 | |
| Contact: Hyman B. Muss, MD 802-656-5487 | |
| United States, West Virginia | |
| St. Mary's Regional Cancer Center at St. Mary's Medical Center | Recruiting |
| Huntington, West Virginia, United States, 25702 | |
| Contact: Gerrit A. Kimmey, MD 304-528-4645 | |
| 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
| Study ID Numbers: | CDR0000321396, CALGB-369901 |
| Study First Received: | September 10, 2003 |
| Last Updated: | November 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00068328 History of Changes |
| Health Authority: | Unspecified |
|
psychosocial effects of cancer and its treatment stage I breast cancer stage II breast cancer |
stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
|
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |
