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

65 Years
Open (Enrolling)
Breast Cancer, Psychosocial Effects of Cancer and Its Treatment

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Trial Information

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


- 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

- 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

Inclusion Criteria


- 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



- 65 and over


- Female

Menopausal status

- Not specified

Performance status

- Any performance status

Life expectancy

- Not specified


- Not specified


- Not specified


- Not specified


- 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


Biologic therapy

- Not specified


- Not specified

Endocrine therapy

- Not specified


- Not specified


- Not specified

Type of Study:


Study Design:


Principal Investigator

Jeanne Mandelblatt, MD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

Lombardi Cancer Research Center


United States: Federal Government

Study ID:




Start Date:

August 2003

Completion Date:

Related Keywords:

  • Breast Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • psychosocial effects of cancer and its treatment
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IA breast cancer
  • stage IB breast cancer
  • estrogen receptor-negative breast cancer
  • estrogen receptor-positive breast cancer
  • Breast Neoplasms



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