NCT02823262.

Trial name or title	A breast cancer treatment decision aid for women aged 70 and older
Methods	RCT
Participants	Inclusion criteria Phase I: Patient age ≥ 70 yrs. Female patient diagnosed with a first primary ER+, HER2‐, LN‐, 3 cm 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 who 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 tumorSigns 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 who answer 3 or more of these questions incorrectly will be excluded.
Interventions	Experimental: decision aid Post Initial Surgical Consultation Including background questionnaire and randomization into decision aid group or control group: The Decision Aid Group (workbook and CD) explains each treatment including its benefits and risks.‐‐ The DA asks women 10 questions about their health;the response to each question is associated with a point value and women are asked to tally their points. The DA groups women into 4 health categories based on their health score. Assessment at one week after participants surgical consultation and five months after surgical consultation Active Comparator: No decision aid Post Initial Surgical Consultation Including background questionnaire and randomization into decision aid group or control group: Participant will receive usual care assistance when making treatment decisions. Assessment at one week after participants surgical consultation and five months after surgical consultation
Outcomes	Primary outcome Change in Decisional Conflict Scale at 1 week Secondary outcomes Knowledge score using our knowledge test Change in Stage of decision‐making at one week using one‐item tool Self‐efficacy using 11‐item scale Values using importance scale 1‐10 Treatment preferences using two‐item tool Desired role in decision‐making using one‐item tool Anxiety using 6‐item Spielberger State‐Trait Anxiety Inventory short‐form Quality of Life using the SF‐12 physical and mental component scores Preparation for decision‐making using 10 items (1‐5 scale) Actual role in decision‐making using one‐item tool Decision Regret using one‐item tool Satisfaction with treatment decision using 4‐item tool Satisfaction with the decision process using 4‐item tool Treatment received using chart abstraction Acceptability using 0‐3 scale
Starting date	July 2016
Contact information	Mara Schonberg, MD MPH, 617‐754‐1414
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