An interventional study of Shared Decision-Making Training and Decision Aid in Breast Cancer, sponsored by Beth Israel Deaconess Medical Center. Recruiting at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Health services research
Investigators aim to conduct a type 1 hybrid effectiveness-implementation surgeon-level cluster randomized clinical trial (RCT) of a multi-level intervention, a shared decision making training for surgeons plus patient decision aid vs. usual care (UC), at 7 large health systems across the U.S. to learn the intervention's effectiveness. Decision aids will be mailed and sent via patient portal and/or via email (when portal/email addresses are available) to patients before their first surgical encounter. The central hypothesis is that the novel intervention will be a key resource to support shared decision making leading to higher quality treatment decisions and as result improved care and outcomes.
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.
To better understand variation in surgeon treatment patterns at baseline, investigators will also conduct a retrospective chart review to review treatments received by women aged 70 and older with clinically node-negative, \<2cm, ER+, HER2- breast cancer within one year prior to a surgeon's completing the study's baseline surgeon questionnaire to learn their baseline likelihood to treat women >70, English/Spanish speaking, diagnosed with a first primary \<2cm, clinically node negative, ER+, HER2- breast cancer with mastectomy, Sentinel lymph node biopsy (SLNB), or RT after BCS.
Investigators will also ask all surgeons to complete a brief end-of-study survey (\<5 minutes to complete) that asks surgeons again the 6 questions about how confident they are in engaging older women in shared decision making around breast cancer treatment and their attitudes towards shared decision making around breast cancer treatment with older women. Surgeons will also be asked to share their thoughts on the decision aid. Since the trial will be complete, the survey will include a link to the decision aid that surgeons in both arms may review to provide feedback on the decision aid. After completing the end-of-study survey, investigators will invite surgeons randomized to the usual care arm to participate in the shared decision making training. All surgeons who participate in the training will be asked to complete an evaluation of the training 6 months later. This time period will allow surgeons time to practice what they learn in the training before completing the evaluation survey. Surgeons randomized to the intervention arm will complete this evaluation 6 months after being trained in shared decision making during the trial while surgeons randomized to the usual care arm will complete this evaluation at least 6 months after the trial has ended since these surgeons can only be trained in shared decision making after the trial has ended. Investigators anticipate surgeons will complete study surveys via a secure web-link; however, investigators will offer surgeons to have a research assistant administer the survey to them or to complete a paper copy of the survey if they prefer.
Investigators aim to recruit at least 44 surgeons practicing at recruitment sites. They further anticipate that these 44 surgeons will see at least 1,120 women eligible to receive the decision aid during the three years of the trial (\~25 patients overall or 8-9 women per year per surgeon). With these numbers investigators anticipate being able to show that 15% fewer patients seen by an intervention arm surgeon will receive low-value care including a mastectomy, radiation after breast conserving surgery or a lymph node biopsy compared to patients who receive care from a usual care arm surgeon, assessed administratively.
Investigators also anticipate that at least 32 surgeons will complete both a baseline study questionnaire and an end-of-study questionnaire which will allow the investigators to detect if there is about a 1-point improvement in the 6-item index evaluating surgeon self-confidence to engage older women in shared decision making around breast cancer treatment (each item is scored 1-7 points and the total score is determined by calculating the mean score on the 6-item index).
In Aim 2, investigators aim to recruit a subset of patients seen by surgeons participating in the Aim 1 parallel group-randomized trial to complete study surveys to capture participant reported outcomes about the intervention (which includes training breast surgeons in shared decision making and providing women aged 70 and older with Stage I [2 centimeters of less], ER+, HER2- breast cancers with a patient decision aid.) Investigators aim to recruit 340 patients or caregivers for women who would not be able to participate because of memory loss to complete a study survey approximately one week after their first surgical encounter and six months later. The investigators estimate that 34 patients will have a caregiver complete the study surveys and they anticipate that 306 women will complete study surveys for themselves. A research assistant will attempt to approach eligible patients seen by a participating surgeon at the time of their initial surgical visit to ask them if they are willing to participate. English and Spanish speaking females without a prior history of breast cancer who have been newly diagnosed with a Stage I [2 centimeters of less], ER+, HER2- breast cancer are eligible since the decision aid being tested was developed for these patients. Investigators do not plan to include biological males since the data informing the decision aid were obtained from studies of biological females and treatment recommendations and outcomes tend to be worse for biological males with breast cancer.
For patients/caregivers who agree to participate, a research assistant (RA) will offer to administer the 1-week survey in person after the visit, to administer the 1-week survey over the telephone in the next three weeks as long as the patient has not yet undergone surgery at the time of the 1-week survey, or to send the patient/caregiver a secure web-link or a paper copy (based on patient/caregiver preference) for the patient/caregiver to self-administer the survey.
The 1-week survey asks patients/caregivers about the quality of shared decision making with their surgeons, their knowledge of the benefits and harms of different breast cancer treatments, their decisional conflict around treatment, their health related quality of life, their preferred role in treatment decisions, their perceived involvement in treatment decisions, and where they are at in terms of treatment decision making. It also asks patients/caregivers their sociodemographics. The 6-month survey asks patients/caregivers about the quality of shared decision making with their radiation oncologists and oncologists, their knowledge of the benefits and harms of endocrine therapy, their decisional conflict around treatment, their health related quality of life, the financial burden of treatment, their satisfaction with their treatment decisions, whether they have any regret about the decisions made, their perceived involvement in treatment decisions, which treatments they received, and about their health care utilization. For patients/caregivers whose surgeon is randomized to the intervention arm, investigators will ask them about their use of the decision aid, whether it was acceptable to them, and whether it prepared them for decision-making. RAs will offer to administer the 6-month survey in person, over the telephone, or to send the patient/caregiver a secure web-link to the survey or a paper copy (based on patient/caregiver preference) for the patient/caregiver to self-administer the survey.
Finally, investigators will use information that patients/caregivers provide on treatments received, health care utilization, and time spent reviewing/delivering the decision aid and training surgeons in shared decision making to determine the costs of our intervention and the costs of care for patients in the usual care arm compared to those in the intervention arm. Investigators will also examine whether there are differences by arm in patient/caregiver health related quality of life. If healthcare costs of patients in the intervention arm are less than those in the usual care arm and their quality of life is better it will be clear that the intervention is a high quality and low cost intervention. If healthcare costs of patients in the intervention arm are higher than those in the usual care arm but their quality of life is better investigators will examine the cost threshold for improved quality life of patients.
In Aim 4, investigators will conduct semi-structured individual qualitative interviews with intervention arm patients (n=12), and caregivers (n=4) and intervention arm surgeons (n=6) at 12 months to learn their thoughts on how implementation of the intervention has gone. At the end-of-study, investigators will also conduct semi-structured individual qualitative interviews with intervention arm patients (n=12), and caregivers (n=4) and intervention arm surgeons (n=6) to learn how best to implement and disseminate the intervention. At the end of the study, investigators will also interview at least 6 administrators and 12 allied health professionals referred by intervention arm surgeons to learn their perspectives on how best to implement the intervention.
In summary, it is expected about 402 people will participate in this research study including 44 surgeons, 306 women aged 70 and older newly diagnosed with 2cm or less, clinically lymph node negative, estrogen receptor positive, HER2- breast cancer without memory problems, 34 of caregivers of women aged 70 and older newly diagnosed with 2cm or less, clinically lymph node negative, estrogen receptor positive, HER2- breast cancer with memory problems, and 18 administrators and/or allied healthcare professionals.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 402 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Surgeon Inclusion Criteria:
Aim 1 Participant Inclusion Criteria: Participants whose medical records will be followed for treatments received and survival
Aim 1 Participant Inclusion Criteria: Participants whose medical records will be reviewed retrospectively for treatments received in the year before the participating surgeon completes the baseline questionnaire
Aim 2 Participant Inclusion Criteria: Participants who will be included in Aim 2 participant surveys to learn patient reported outcomes
Primary caregiver Inclusion Criteria:
Allied health professionals (Aim 4 at the end of the trial) Inclusion Criteria:
Surgeon Exclusion Criteria:
Aim 1 Participant Exclusion criteria: Participants whose medical records will be followed for treatments received and survival
Aim 1 Participant Exclusion Criteria: Participants whose medical records will be reviewed retrospectively for treatments received in the year before the participating surgeon completes the baseline questionnaire
Aim 2 Participant Exclusion Criteria: Participants who will be included in Aim 2 participant surveys to learn patient reported outcomes
Primary Caregiver Exclusion Criteria:
Allied health professionals (Aim 4 at the end of the trial) Exclusion Criteria:
22 enrolled surgeon participants will be randomized and will complete: * Baseline questionnaire * Virtual 1 hour training on SDM * 3-month training follow up survey * At Month 12: 6 surgeon participants will take part in a semi-structured interview with research assistant/PI by phone, in-person, or virtually * End-of-study survey * At end of study 6 surgeon participants will take part in a semi-structured interview with research assistant/PI by phone, in-person, or virtually. Approximately, 153 patients and 17 caregivers will be in this arm. They will complete a survey at 1 week and 6 months. At 12 months investigators will ask 12 patients and 4 caregivers to complete a qualitative interview. At end of study investigators will ask 12 patients and 4 caregivers to complete a qualitative semi-structured interview with research assistant/PI by phone, in-person, or virtually.
Behavioral: Shared Decision-Making Training and Decision Aid
22 enrolled surgeons will be randomized to usual care and will complete: * Baseline questionnaire * End-of-study survey * May choose to participat in End-of-study virtual 1 hour training on SDM * 3-month training follow up survey evaluating the training Approximately, 153 patients and 17 care-givers will be in this arm. They will complete a survey at 1 week and 6 months.
The intervention includes training surgeons in shared decision making techniques and providing eligible participants with a tailored breast cancer treatment decision aid prior to the initial surgical consultation.
Also known as: SDM and DA
Receipt of aggressive treatment within 6 months of First Surgical Encounter (Arm A)
Research staff will review the medical records for all participants with eligible tumor and study characteristics seen by a participating surgeon during the trial to learn whether aggressive treatments were received (mastectomy, radiation treatment, sentinel lymph node biopsy \[SLNB\] or axillary dissections and/or systemic therapy) within 6 months of each participant's first surgical consultation.
Time frame: 6 months
Participant Perceived Shared Decision Making Quality Scale Score (Arm D)
Assessed by the SDM Process Scale: 4 items-scored 0-4 with a total scores range of 0 to 8; patient/caregiver participant perspectives on how much surgeon reviewed reasons for having/not having radiotherapy after breast conserving surgery and for having SLNB. It also assesses if participants perceive being given a choice or asked about preferences.
Time frame: at 1 week
Participant Perceived Shared Decision Making Quality Scale Score (Arm A)
Assessed by the SDM Process Scale: 4 items-scored 0-4 with a total scores range of 0 to 8; patient/caregiver participant perspectives on how much surgeon reviewed reasons for having/not having radiotherapy after breast conserving surgery and for having SLNB. It also assesses if participants perceive being given a choice or asked about preferences.
Time frame: at 1 week
Receipt of aggressive treatment within 6 months of First Surgical Encounter (Arm D)
Research staff will review the medical records for all participants with eligible tumor and study characteristics seen by a participating surgeon during the trial to learn whether aggressive treatments were received (mastectomy, radiation treatment, sentinel lymph node biopsy \[SLNB\] or axillary dissections and/or systemic therapy) within 6 months of each participant's first surgical consultation.
Time frame: 6 months
Participant Decisional Conflict Scale Score (Arm A)
Assessed from patient/caregiver participants by the Decisional Conflict Scale of 10-items scored on three response options (0 "Yes," 4 "No," 2 "Unsure") for four subscales uncertainty, feeling informed, clear in one's values, and supported in the decision. A total scores range is 0 "No conflict" to 100 "extremely high conflict."
Time frame: 1 week
Participant Decisional Conflict Scale Score (Arm D)
Assessed from patient/caregiver participants by the Decisional Conflict Scale of 10-items scored on three response options (0 "Yes," 4 "No,"2 "Unsure") for four subscales assessing uncertainty, feeling informed, clear in one's values, and supported in the decision. A total scores range is 0 "No conflict" to 100 "extremely high conflict."
Time frame: 1 week
Participant Knowledge Score at 1 week (Arm A)
Assessed from patients/caregivers by 8 true/false items at 1 week about surgery and radiation. Total score is questions answered correctly (range 0-10)
Time frame: 1 week
Participant Knowledge Score at 6 Months (Arm A)
Assessed from patient/caregiver participants by 3 true/false items at 6 months about endocrine therapy. Total score is questions answered correctly (range 0-3).
Time frame: 6 months
Participant Knowledge Score at 1 week (Arm D)
Assessed patient/caregiver participants by 8 true/false items at 1 week about surgery and radiation. Total score is questions answered correctly (range 0-10)
Time frame: 1 week
Participant Knowledge Score at 6 Months (Arm D)
Assessed patient/caregiver participants by 3 true/false items at 6 months about endocrine therapy. Total score is questions answered correctly (range 0-3).
Time frame: 6 months
Financial toxicity (Arm A)
Assessed by the 12 item Cost-Functional Assessment of Chronic Illness Therapy (0-48 score)
Time frame: 6 months
Financial toxicity (Arm D)
Assessed by the 12 item Cost-Functional Assessment of Chronic Illness Therapy (0-48 score)
Time frame: 6 months
Change in Surgeon Self-Efficacy Scale Score from Baseline to End of Study (Arm B)
Assessed by the Self-Efficacy Scale, surgeons report on 7 items scored on 7-point scale: 1 "strongly disagree" to 7 "strongly agree." A total score will be the mean and will range from 1 to 7. A higher score indicates greater self-efficacy.
Time frame: Baseline and at end of the study. End of study will vary from 6 months to 4 years
Change in Surgeon Self-Efficacy Scale Score from Baseline to End of Study (Arm E)
Assessed by the Self-Efficacy Scale, surgeons report 7 items scored on 7-point scale: 1 "strongly disagree" to 7 "strongly agree." A total score will be the mean and will range from 1 to 7. A higher score indicates greater self-efficacy.
Time frame: Baseline and at end of the study. End of study will vary from 6 months to 4 years
Desired role in breast cancer treatment decision making (Arm A)
1- item that assesses how involved patients/caregivers want to be in treatment decisions.
Time frame: 1 week
Desired role in breast cancer treatment decision making (Arm D)
1- item that assesses how involved patients/caregivers want to be in treatment decisions.
Time frame: 1 week
Actual role in breast cancer treatment decision making (Arm A)
1 item that assesses how involved patients/caregivers were in treatment decisions.
Time frame: 6 months
Actual role in breast cancer treatment decision making (Arm D)
1 item that assesses how involved patients/caregivers were in treatment decisions.
Time frame: 6 months
Decisional Regret (Arm A)
5 item decisional regret scale
Time frame: 6 months
Decisional Regret (Arm D)
5 item decisional regret scale
Time frame: 6 months
Decision satisfaction (Arm A)
1 item- 5-point scale: I am satisfied with my breast cancer treatment choices
Time frame: 6 months
Decision satisfaction (Arm D)
1 item- 5-point scale: I am satisfied with my breast cancer treatment choices
Time frame: 6 months
Perceived involvement in treatment decisions with surgeons (Arm A)
4 items, 2 scales: 1) patient information seeking scale (perceptions of self-efficacy to ask surgeons questions) and 2) surgeon-initiated communication scale
Time frame: 1 week
Perceived involvement in treatment decisions with surgeons (Arm D)
4 items, 2 scales: 1) patient information seeking scale (perceptions of self-efficacy to ask surgeons questions) and 2) surgeon-initiated communication scale
Time frame: 1 week
Plan to share: Yes — All deidentified study data will be made available as public use data to the research community via a Harvard Dataverse Repository. Users will be required to agree to terms that prohibit unlawful uses and intentional violations of privacy, and require attribution. Use of the data will be otherwise unrestricted and free of charge.
Supporting information: Study protocol, Analytic code
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Beth Israel Deaconess Medical Center