Chemotherapy Decisions and Outcomes in Older Women With Newly Diagnosed Breast Cancer



Status:Completed
Conditions:Breast Cancer, Cancer, Cancer, Psychiatric
Therapuetic Areas:Oncology, Psychiatry / Psychology
Healthy:No
Age Range:65 - Any
Updated:8/9/2017
Start Date:August 2003
End Date:December 2016

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Observational Cohort Study: Chemotherapy Decisions and Outcomes in Women Age 65 or Older With Operable, Newly Diagnosed Breast Cancer

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.

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.

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

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
We found this trial at
85
sites
100 Michigan Street, NE, MC012
Grand Rapids, Michigan 49503
(616) 391-1230
CCOP - Grand Rapids The Grand Rapids Clinical Oncology Program (GRCOP) is a community cancer...
733
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Grand Rapids, MI
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
1443
mi
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Boston, MA
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
1057
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Buffalo, NY
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115 Business loop 70 w
Columbia, Missouri 65203
(573) 882-2100
Ellis Fischel Cancer Center at University of Missouri - Columbia At Ellis Fischel Cancer Center,...
308
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Columbia, MO
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166 Stoneridge Drive
Columbia, South Carolina 29210
803-461-3000
South Carolina Oncology Associates, PA South Carolina Oncology Associates (SCOA) is the only comprehensive cancer...
968
mi
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125 Science Dr
Durham, North Carolina 27710
888.275.3853
Duke Comprehensive Cancer Center Leading-edge cancer care and research have been a hallmark of Duke...
1051
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Durham, NC
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1800 West Charleston Boulevard
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(702) 383-2000
University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
962
mi
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One Medical Center Drive
Lebanon, New Hampshire 03756
(603) 653-9000
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1393
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985950 Nebraska Medical Center
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402-559-4090
UNMC Eppley Cancer Center at the University of Nebraska Medical Center The Fred & Pamela...
259
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100 Campus Dr # 108
Scarborough, Maine 04074
(207) 396-7600
Maine Center for Cancer Medicine and Blood Disorders - Scarborough Maine Center for Cancer Medicine...
1489
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Attleboro, Massachusetts 02703
1431
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Attleboro, MA
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1154
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Baltimore, MD
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300 North Ave
Battle Creek, Michigan 49017
(269) 245-8000
Battle Creek Health System Cancer Care Center As a proud member of the Battle Creek...
738
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1035
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130 Fisher Road
Berlin Corners, Vermont 05602
1384
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605 Oak St
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(231) 796-8691
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764
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1441
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(617) 632-6364
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1444
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1356
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101 Manning Drive
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(919) 966-0000
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1038
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232 S Woods Mill Rd
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400
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609
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Chicago, Illinois 60640
611
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250 Pleasant Street
Concord, New Hampshire 03301
603-224-2556
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1425
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5008 Brittonfield Parkway
East Syracuse, New York 13057
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1198
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685
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500 Arcade Blvd, Ste 240
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Exeter, NH
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1114
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Fairfax, VA
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Fayetteville, North Carolina 28302
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298 Washington St
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1465
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220
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Grand Rapids, Michigan 49503
733
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Grand Rapids, MI
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250 Cherry St SE
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(616) 685-5225
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1307
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Henderson, North Carolina 27536
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200 Technology Drive
Hooksett, New Hampshire 03106
603-622-6484
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1428
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840
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Hyannis, Massachusetts 02601
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Kokomo, Indiana 46904
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(708) 245-9000
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596
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1007 LINCOLNWAY
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1288
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Lake Worth, FL
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960
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Livingston, New Jersey 07039
1270
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295 Varnum Ave
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1427
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Merrillville, Indiana 46410
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676
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1700 Oak Ave.
Muskegon, Michigan 49444
231-672-2000
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Myrtle Beach, South Carolina 29572
1099
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Nashua, New Hampshire 03060
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1275 York Ave
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(212) 639-2000
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New York, NY
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4 Longmeadow Village Dr
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(269) 683-4153
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675
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276
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North Platte, NE
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155 Memorial Drive P O Box 3000
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(910) 715-1000
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1033
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1277
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Pismo Beach, CA
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1915 Lake Ave
Plymouth, Indiana 46563
574-936-2585
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660
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Plymouth, IN
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Raleigh, North Carolina 27609
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1123
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Rochester, NY
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559
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Roxboro, North Carolina 27573
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1092 Lydia Dr
Saint Joseph, Michigan 49085
(269) 428-4411
670
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670
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415
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Saint Louis, MO
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Saint Louis, Missouri 63128
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South Bend, Indiana 46601
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South Bend, Indiana 46601
(574) 647-1000
Memorial Hospital of South Bend Memorial Hospital of South Bend is a community-owned, not-for-profit corporation...
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211 North Eddy St.
South Bend, Indiana 46617
574-234-8161
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672
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105 Sixth St
Traverse City, Michigan 49684
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793
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1159
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110 Irving Street Northwest
Washington, D.C., District of Columbia 20010
1128
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1127
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636
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5900 Byron Center Ave SW
Wyoming, Michigan 49519
(616) 252-7200
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730
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