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
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Chicago, Illinois 60640
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185 Cambridge Street
Boston, Massachusetts 02114
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666 Elm Street
Buffalo, New York 14263
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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115 Business loop 70 w
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166 Stoneridge Drive
Columbia, South Carolina 29210
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125 Science Dr
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1800 West Charleston Boulevard
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University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
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One Medical Center Drive
Lebanon, New Hampshire 03756
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100 Campus Dr # 108
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Attleboro, Massachusetts 02703
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130 Fisher Road
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232 S Woods Mill Rd
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250 Pleasant Street
Concord, New Hampshire 03301
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100 Michigan Street, NE, MC012
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