SDM POSSIBLE: A Cluster RCT of a Breast Cancer Treatment Decision Aid for Women 70+ With Low-Risk Stage I Breast Cancers

In a parallel group-randomized trial, investigators aim to test the effects of training breast surgeons in shared decision making and providing their female patients aged 70 and older with Stage 1 (2 centimeters or less), estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer a patient decision aid on breast cancer treatment. The decision aid is novel in that it includes comprehensive information about the benefits and harms of the different breast cancer treatments that older woman may be offered. It also highlights the complex interplay between their multiple treatment options and their health, life expectancy, values and preferences.

The investigators plan to recruit 44 surgeons from six different health systems (including Beth Israel Lahey Health, Dana Farber Cancer Institute, University of Rochester, Duke University Medical Center, City of Hope, and Rutgers University) to participate in this trial. To participate, a surgeon must agree to complete a previously developed 1-hour training in shared decision making and to allow their eligible patients to be sent the patient decision aid if randomized to the intervention. In order to participate, surgeons must also complete a baseline survey that takes <2 minutes to complete and asks surgeons 6 questions about how confident they are in engaging older women in shared decision making around breast cancer treatment. Surgeons must confirm that they consent to participate on the baseline survey.

Once a surgeon agrees to participate and completes the baseline survey they will be randomized to either the intervention arm or to the usual care arm. Surgeons randomized to the usual care arm will continue with their usual treatment discussions without being provided any support for shared decision making so that investigators may learn the effects of the intervention compared to real-world practice. Investigators will wait 8 weeks after a surgeon completes the baseline survey before following eligible patients in their panel to allow surgeons randomized to the intervention arm time to participate in the shared decision making training. Dr. Schonberg, the principal investigator of this study, will offer many times and make herself widely available to intervention arm surgeons to provide the live televideo training in shared decision making. If the 8 week mark is approaching and the intervention arm surgeon has not been able to schedule a time to complete the training, then Dr. Schonberg will send the surgeon a video copy of the training to watch. During the training, surgeons practice shared decision making using their own language. Intervention arm surgeons will also receive access to a secure website with all the decision support tools and strategies discussed in the training. In addition, investigators will invite intervention arm surgeons to submit challenging cases of decision making with women aged 70 and older with Stage I, ER+, HER2- breast cancer for feedback throughout the trial. The research team will send any feedback shared and updates in shared decision making to all intervention arm surgeons throughout the trial through a study newsletter every 6 months. Every year, investigators will thank surgeons in both arms for their participation and will send them an update regarding study recruitment.

To identify patients in participating surgeon panels who may be eligible to receive the decision aid, a research assistant (RA) at each site will review the appointment logs of participating surgeons at least twice a week during the trial to identify eligible women. Women aged 70 and older with Stage I, ER+, HER2- breast cancer are eligible to receive the decision aid if they are English or Spanish-speaking since the decision aid has been developed in English and Spanish. RAs will mail all patients the decision aid via express mail (or overnight mail if needed to reach the patient before their first surgical encounter). RAs will also email patients the decision aid if they have an email listed in the electronic medical record (EMR) and they will send the decision aid to patients via the patient portal if the patient has registered with the portal. When sending patients the decision aid, RAs will include a cover letter that explains the purpose of the decision aid (that it was designed to support communication between breast surgeons and women age 70 and older) and that some women may find it helpful to read the decision aid before, during, or right after their first visit with their breast surgeon.

To learn the effect of the intervention on treatments received by women aged 70 and older with Stage I, ER+, HER2- breast cancer, a RA will review the medical records of all patients with eligible tumor and study characteristics in a participating surgeon's panel to see what treatments they received within six months of their initial surgical visit. The chart abstraction instrument assesses whether a patient received a mastectomy, lumpectomy, radiation therapy, lymph node surgery, and endocrine therapy as well as any comorbidities listed in the patient's problem list. At the end of the study, the research assistant will also review patients' medical records to learn if the patient experienced a breast cancer recurrence, is still alive, and if not, the cause of death. Investigators will follow patients for this information between 6 months and 3.5 years depending on when the patient is seen by a participating surgeon during the trial.