Breast Cancer Clinical Trial

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

Summary

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.

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Estimated Enrollment:

65

Study ID:

NCT02823262

Recruitment Status:

Terminated

Sponsor:

Beth Israel Deaconess Medical Center

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There is 1 Location for this study

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Beth Israel Deaconess Medical Center
Boston Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

65

Study ID:

NCT02823262

Recruitment Status:

Terminated

Sponsor:


Beth Israel Deaconess Medical Center

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