A Breast Cancer Treatment Decision Aid for Women Aged 70 and Older

NOT ENROLLING
Protocol # :
16-117
Conditions
Breast Cancer
Estrogen Receptor Positive Breast Cancer
Node-negative Breast Cancer
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Phase
Not Applicable
Disease Sites
Breast
Principal Investigator
Schonberg, Mara
Site Investigator
Dominici, Laura, Stewart
Nakhlis, Faina

Trial Description

The purpose of this research study is to evaluate a decision aid to help women aged 70 and
older decide on treatment for their breast cancer.

Eligibility Requirements

Inclusion Criteria:

- Phase I

- Patient age ≥ 70 yrs

- Female patient diagnosed with a first primary ER+, HER2-, LN-, 3cm or less breast
cancer >6 months ago but <2 years ago

- Caregiver age >21 years

- English speaking

- Phase II

- Female patient age ≥ 70 yrs newly diagnosed with a first primary ER+, HER2-, LN-,
3cm or less breast cancer

- Women newly diagnosed with breast cancer on the day of surgical consult

Exclusion Criteria:

- Phase I

- Patient Age < 70 years

- Women diagnosed with Paget's disease, inflammatory breast cancer or a phyllodes
tumor

- Signs of Dementia

- Score >10 on the Orientation-Memory-Concentration (OMC) test

- Non-English Speaking;

- Caregiver age < 21 years

- Women who do not have capacity to participate. --- Before enrolling women in this
study, possible participants will be asked 7 questions about the benefits and
risks of the study. Women that answer 3 or more of these questions incorrectly
will be excluded.

- Phase II

- Women with a history of breast cancer (invasive and non-invasive)

- Diagnosed with Paget's disease, inflammatory breast cancer or a phyllodes tumor

- Signs of Dementia

- Score >10 on the OMC test (indicative of dementia).

- Women who do not have capacity to participate. --- Before enrolling women in this
study, possible participants will be asked 7 questions about the benefits and
risks of the study. Women that answer 3 or more of these questions incorrectly
will be excluded.

16-117