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Clinical Trial: Chemotherapy Decisions and Outcomes in Older Women With Newly Diagnosed Breast Cancer
This study is currently recruiting patients.
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 | Treatment or Intervention |
|---|---|
| Quality of Life psychosocial effects/treatment stage I breast cancer stage II breast cancer stage IIIA breast cancer | Procedure: psychosocial assessment/care Procedure: quality-of-life assessment Procedure: supportive care/therapy |
MedlinePlus related topics: Breast Cancer
Genetics Home Reference related topics: breast cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Study of Chemotherapy Decisions and Outcomes in Women Age 65 and Over With Operable, Newly Diagnosed Breast Cancer
Further Study Details:
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.
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 above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed primary adenocarcinoma of the breast
- Operable disease
- No more than 16 weeks since diagnosis
- T1-3, any N, M0
- No prior carcinoma , lobular carcinoma , ductal carcinoma , 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
- 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
Other
- No concurrent enrollment on CLB-49907
Location and Contact Information
Alabama
Northeast Alabama Regional Medical Center, Anniston, Alabama, 36207, United States; Recruiting
Thomas W. Twele, MD 256-236-2549
California
Naval Medical Center - San Diego, San Diego, California, 92134-3202, United States; Recruiting
Preston Gable, MD 619-532-7303 pgable@nmcsd.med.navy.mil
Rebecca and John Moores UCSD Cancer Center, La Jolla, California, 92093-0658, United States; Recruiting
Stephen L. Seagren, MD 619-543-5303
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States; Recruiting
Alan T. Lefor, MD 310-423-5874 Alan.Lefor@cshs.org
UCSF Comprehensive Cancer Center, San Francisco, California, 94115, United States; Recruiting
Alan Paul Venook, MD 800-888-8664 venook@cc.ucsf.edu
Veterans Affairs Medical Center - San Diego, San Diego, California, 92161, United States; Recruiting
Saeeda Kirmani, MD 619-552-8585 ext. 3356 skirmani@ucsd.edu
Veterans Affairs Medical Center - San Francisco, San Francisco, California, 94121, United States; Recruiting
Patricia A. Cornett, MD 415-221-4810 ext. 3423 patricia.cornett@med.va.gov
Delaware
CCOP - Christiana Care Health Services, Newark, Delaware, 19713, United States; Recruiting
Stephen Scott Grubbs, MD 302-623-4100
District of Columbia
Lombardi Cancer Center at Georgetown University Medical Center, Washington, District of Columbia, 20007, United States; Recruiting
Edward P. Gelmann, MD 202-444-7303 gelmanne@georgetown.edu
Veterans Affairs Medical Center - Washington, DC, Washington, District of Columbia, 20422, United States; Recruiting
Steven H. Krasnow, MD 202-745-8178 krasnow.steven@washington.va.gov
Walter Reed Army Medical Center, Washington, District of Columbia, 20307-5001, United States; Recruiting
Thomas Joseph Reid, MD, PhD, FACP 202-782-5762 thomas.reid@na.amedd.army.mil
Florida
Broward General Medical Center, Fort Lauderdale, Florida, 33316, United States; Recruiting
Luis Ramon Barreras, MD, FACP 954-771-0692
CCOP - Mount Sinai Medical Center, Miami Beach, Florida, 33140, United States; Recruiting
Rogerio C. Lilenbaum, MD 305-674-2625
Memorial Cancer Institute at Memorial Regional Hospital, Hollywood, Florida, 33021, United States; Recruiting
Atif M. Hussein, MD 954-986-6363 ahussein@mhs.net
Palm Beach Cancer Institute - West Palm Beach, West Palm Beach, Florida, 33401, United States; Recruiting
Robert J. Jacobson, MB, ChB, FACP, FRCP(C) 561-366-4150
Illinois
CCOP - Evanston, Evanston, Illinois, 60201, United States; Recruiting
Gershon Y. Locker, MD, FACP 847-570-2518 glocker@enh.org
CCOP - Illinois Oncology Research Association, Peoria, Illinois, 61615-7828, United States; Recruiting
John W. Kugler, MD 309-243-3605
Louis A. Weiss Memorial Hospital, Chicago, Illinois, 60640, United States; Recruiting
Keith L. Shulman, MD 773-564-5022 KShulman@weisshospital.org
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, 60612, United States; Recruiting
Lawrence Eric Feldman, MD 312-335-3614
University of Chicago Cancer Research Center, Chicago, Illinois, 60637-1470, United States; Recruiting
Karen Wendling 773-834-7424
Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, 60612, United States; Recruiting
Thomas E. Lad, MD 312-996-2046
West Suburban Center for Cancer Care, River Forest, Illinois, 60305, United States; Recruiting
John L. Showel, MD 708-763-2700 doc.shoj@wsmc.org
Indiana
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, 46601, United States; Recruiting
Rafat H. Ansari, MD, FACP 574-284-7977
Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne, Indiana, 46885-5099, United States; Recruiting
Sreenivasa Rao Nattam, MD 260-484-8830 ledgar@fwmoh.com
Iowa
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, 52242-1009, United States; Recruiting
Gerald H. Clamon, MD 319-356-8110
Kentucky
Baptist Hospital East - Louisville, Louisville, Kentucky, 40207, United States; Recruiting
Daniel C. Scullin, MD 502-897-1166
Maryland
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, 21201, United States; Recruiting
Martin J. Edelman, MD 410-328-2703 medelman@umm.edu
Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, 02115, United States; Recruiting
George P. Canellos, MD 617-632-3470 george_canellos@dfci.harvard.edu
UMASS Memorial Cancer Center - University Campus, Worcester, Massachusetts, 01655, United States; Recruiting
Pankaj Bhargava 508-856-6884 bhargavp@ummhc.org
Michigan
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph, Saint Joseph, Michigan, 49085, United States; Recruiting
Cynthia Bender, BA, CRA 269-985-4516 cbender@lakelandregional.org
Minnesota
University of Minnesota Cancer Center, Minneapolis, Minnesota, 55455, United States; Recruiting
Bruce A. Peterson, MD 612-624-5631
Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota, 55417, United States; Recruiting
Vicki A. Morrison, MD 612-467-4135 morri002@tc.umn.edu
Missouri
CCOP - Kansas City, Kansas City, Missouri, 64131, United States; Recruiting
William T. Stephenson, MD 816-823-0555
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, 65203, United States; Recruiting
Michael C. Perry, MD 573-882-4979 perrym@health.missouri.edu
Missouri Baptist Cancer Center, Saint Louis, Missouri, 63131, United States; Recruiting
Alan Philip Lyss, MD 314-996-5514 alyss@bjc.org
Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis, Missouri, 63110, United States; Recruiting
Nancy L. Bartlett, MD 314-362-4843
Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia, Missouri, 65201, United States; Recruiting
William P. Patterson, MD 573-882-6163
Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska, 68198-7680, United States; Recruiting
Margaret Anne Kessinger, MD 402-559-7511 makessin@unmc.edu
Nevada
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, 89106, United States; Recruiting
John Allan Ellerton, MD, CM 702-384-0013 k.vanwagenen@sncrf.org
Veterans Affairs Medical Center - Las Vegas, Las Vegas, Nevada, 89106, United States; Recruiting
Chitha R. Hulugalle, MD 702-696-3000
New Hampshire
New Hampshire Oncology-Hematology, PA - Hooksett, Hooksett, New Hampshire, 03106, United States; Recruiting
Douglas Jay Weckstein, MD 603-622-6484 d.weckstein@nhoh.com
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, 03756-0002, United States; Recruiting
Marc Stuart Ernstoff, MD 603-650-5534 Marc.S.Ernstoff@Hitchcock.org
New Jersey
Cancer Institute of New Jersey at the Cooper University Hospital, Camden, New Jersey, 08103, United States; Recruiting
Edison Catalano, MD 856-342-2506
New York
CCOP - North Shore University Hospital, Manhasset, New York, 11030, United States; Recruiting
Vincent P. Vinciguerra, MD 516-562-8954
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., East Syracuse, New York, 13057, United States; Recruiting
Jeffrey J. Kirshner, MD 315-472-7504
Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting
Clifford A. Hudis, MD 212-639-6483
Mount Sinai Medical Center, New York, New York, 10029, United States; Recruiting
Lewis R. Silverman, MD 212-241-5520 lewis.silverman@mssm.edu
New York Weill Cornell Cancer Center at Cornell University, New York, New York, 10021, United States; Recruiting
Scott Wadler, MD 212-746-2844 scw2004@med.cornell.edu
North Shore University Hospital, Manhasset, New York, 11030, United States; Recruiting
Daniel R. Budman, MD 516-562-8958
Queens Cancer Center of Queens Hospital, Jamaica, New York, 11432, United States; Recruiting
Hans W. Grunwald, MD 718-883-4118 hans.grunwald@mssm.edu
Roswell Park Cancer Institute, Buffalo, New York, 14263-0001, United States; Recruiting
Ellis G. Levine, MD 716-845-8547
SUNY Upstate Medical University Hospital, Syracuse, New York, 13210, United States; Recruiting
Stephen L. Graziano, MD 315-464-8200 grazians@upstate.edu
Veterans Affairs Medical Center - Buffalo, Buffalo, New York, 14215, United States; Recruiting
Lynn Marie Steinbrenner, MD 716-862-3191 lynn.steinbrenner@med.va.gov
Veterans Affairs Medical Center - Syracuse, Syracuse, New York, 13210, United States; Recruiting
Leslie Marion Howard, MD 315-476-7461 ext. 4018 leslie.howard@med.va.gov
North Carolina
Cape Fear Valley Medical Center, Fayetteville, North Carolina, 28302-2000, United States; Recruiting
Kamal M. Bakri, MD 910-609-6910
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina, 27534-9479, United States; Recruiting
James N. Atkins, MD 336-777-3088
Comprehensive Cancer Center at Moore Regional Hospital, Pinehurst, North Carolina, 28374, United States; Recruiting
Ellen M. Willard, MD 910-295-9205
Comprehensive Cancer Center at Wake Forest University, Winston Salem, North Carolina, 27157-1082, United States; Recruiting
David Duane Hurd, MD 336-716-2088 dhurd@wfubmc.edu
Duke Comprehensive Cancer Center, Durham, North Carolina, 27710, United States; Recruiting
Jeffrey Crawford, MD 919-684-5621 crawf006@mc.duke.edu
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, 27599-7295, United States; Recruiting
Thomas C. Shea, MD 919-966-7746 sheaT@med.unc.edu
NorthEast Oncology Associates - Concord, Concord, North Carolina, 28025, United States; Recruiting
James Grier Wall, MD 704-783-1370 jwall@northeastmedical.org
Veterans Affairs Medical Center - Asheville, Asheville, North Carolina, 28805-9913, United States; Recruiting
John C. Lucke, MD 828-299-2540
Veterans Affairs Medical Center - Durham, Durham, North Carolina, 27705, United States; Recruiting
Michael J. Kelley, MD 919-286-0411 ext. 7326
Zimmer Cancer Center at New Hanover Regional Medical Center, Wilmington, North Carolina, 28402-9025, United States; Recruiting
Cyrus A. Kotwall, MD 910-763-4630
Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus, Ohio, 43210-1240, United States; Recruiting
Clara D. Bloomfield, MD 614-293-7518 bloomfield-1@medctr.osu.edu
Oklahoma
Oklahoma University Medical Center, Oklahoma City, Oklahoma, 73104, United States; Recruiting
Howard Ozer, MD, PhD 405-271-4022
Pennsylvania
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, 15224, United States; Recruiting
Richard K. Shadduck, MD 412-578-4355 rshadduck@msn.com
Rhode Island
Miriam Hospital at Lifespan, Providence, Rhode Island, 02906, United States; Recruiting
William M. Sikov, MD 401-793-7151 wsikov@lifespan.org
Vermont
Vermont Cancer Center at University of Vermont, Burlington, Vermont, 05401-3498, United States; Recruiting
Hyman Bernard Muss, MD 802-847-3827
Virginia
Martha Jefferson Hospital, Charlottesville, Virginia, 22902, United States; Recruiting
Stefan M. Gorsch, MD 434-982-8410
MBCCOP - Massey Cancer Center, Richmond, Virginia, 23298-0037, United States; Recruiting
John D. Roberts, MD 804-828-0450
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke, Roanoke, Virginia, 24014, United States; Recruiting
Paul D. Richards, MD 540-982-0237 paul.richards@usoncology.com
Virginia Oncology Associates - Norfolk, Norfolk, Virginia, 23502, United States; Recruiting
Paul R. Conkling, MD 757-466-8683
West Virginia
St. Mary's Medical Center, Huntington, West Virginia, 25701, United States; Recruiting
Gerrit A. Kimmey, MD 304-528-4645
Study chairs or principal investigators
Jeanne Mandelblatt, MD, MPH, Study Chair, Lombardi Cancer Research Center
Alice B. Kornblith, PhD, Dana-Farber/Harvard Cancer Center
Hyman Bernard Muss, MD, Vermont Cancer Center at University of Vermont
Stephen Barrow Edge, MD, Roswell Park Cancer Institute
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers: CDR0000321396; CALGB-369901; NCT00068328
Record last reviewed: December 2004
Last Updated: April 5, 2005
Record first received: September 10, 2003
ClinicalTrials.gov Identifier: NCT00068328
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: December 2004
Last Updated: April 5, 2005
Record first received: September 10, 2003
ClinicalTrials.gov Identifier: NCT00068328
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
Resources
- External Quality Assessment (Centers for Disease Control and Prevention)
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