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



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:70 - Any
Updated:2/9/2019
Start Date:July 2016
End Date:July 2024
Contact:Mara Schonberg, MD MPH
Phone:617-754-1414

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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.

The investigators aim to use this information to further refine and evaluate a decision aid
to help newly-diagnosed women aged 70 and older with breast cancer understand the risks and
benefits of different types of breast cancer treatment. The Decision Aid (DA) was created for
women 70 years or older diagnosed with ER+, HER2-, clinically LN-, 3cm or less breast cancers
deciding on breast cancer treatment. The DA was designed considering the health literary,
cognitive abilities, treatment outcomes, and competing health issues of older women.

Phase I :

- The investigators will obtain and incorporate additional feedback on the DA from women 70
years or older who were diagnosed with breast cancer > 6 months ago, their family members,
and clinicians, so that the DA can be refined and evaluated by women who were recently
treated for breast cancer but not newly diagnosed with breast cancer.

Phase II

- The investigators plan to test the efficacy of the revised DA in a randomized control trial
(RCT) of 230 diverse women 70 years or older newly diagnosed with ER+, LN-, HER2-, 3 cm or
less breast cancer.

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.
We found this trial at
2
sites
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Mara Schonberg, MD MPH
Phone: 617-754-1414
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Faina Nakhlis, MD
Phone: 617-983-7777
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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