Clinical trial NCT06896474: SDM POSSIBLE: A Breast Cancer Treatment Decision Aid for Women 70+ With Low-Risk Stage I Breast Cancers
Official title: SDM POSSIBLE: A Cluster RCT of a Breast Cancer Treatment Decision Aid for Women 70+ With Low-Risk Stage I Breast Cancers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Neoplasm
Breast Neoplasms
Breast Cancer
ER+ Breast Cancer
HER2-negative Breast Cancer
Keywords: Breast Neoplasm
Breast Neoplasms
Breast Cancer
ER+ Breast Cancer
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 402
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled trial at the surgeon level
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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 6 large health systems in 4 regions 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.

Detailed description: 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.

Eligibility criteria: Surgeon Inclusion Criteria:

* Non-resident surgeon \>18 years old
* Cares for women \>/= 70 years at one of the recruitment practices.
* Ability and willingness to provide verbal consent

Aim 1 Participant Inclusion Criteria: Participants whose medical records will be followed for treatments received and survival

* Biological female
* aged 70 or older
* first primary invasive breast cancer
* clinically \</=2 cm
* clinically lymph node negative
* estrogen receptor positive (ER+) -HER2-
* scheduled with a participating surgeon for an initial encounter. Females with ER+ breast cancer will be included regardless of their progesterone receptor (PR) status since treatment decisions are similar for ER+/PR+ and ER+/PR- women.

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

* Biological female
* aged 70 or older
* a first primary invasive breast cancer
* clinically \</=2 cm
* clinically lymph node negative
* estrogen receptor positive(ER+) -HER2-
* saw a participating surgeon for an initial encounter in the year before the surgeon completed the baseline questionnaire.

Aim 2 Participant Inclusion Criteria: Participants who will be included in Aim 2 participant surveys to learn patient reported outcomes

* Biological female
* aged 70 or older
* first primary invasive breast cancer
* clinically \</=2 cm
* clinically lymph node negative
* estrogen receptor positive (ER+) -HER2-
* scheduled with a participating surgeon for an initial encounter. If a patient completes the baseline questionnaire and then is found to have different tumor characteristics (e.g., found to be lymph node positive during surgery), investigators plan to retain the patient in the study and ask them to complete the second survey.

Primary caregiver Inclusion Criteria:

* primary family, friend, or non-paid caregiver (herein referred to as caregiver) of a patient unable or unwilling to complete study questionnaires due to cognitive decline. The primary family, friend, or non-paid caregiver will be identified by the patient, self-identified, or documented as the decision maker in the medical record.
* Age \>18
* English or Spanish speaking
* Ability and willingness to provide verbal consent

Allied health professionals (Aim 4 at the end of the trial) Inclusion Criteria:

* Administrator, social worker, physician assistant, navigator, nurse or other allied health professional in breast surgery
* Ability and willingness to provide verbal consent

Surgeon Exclusion Criteria:

* Resident surgeon
* Non-surgeons
* Psychiatric illness situations that would limit compliance with study requirements

Aim 1 Participant Exclusion criteria: Participants whose medical records will be followed for treatments received and survival

* Age \<70
* Biological males: Biological males will be excluded since the data informing the DA were obtained from studies of biological females and treatment recommendations and outcomes tend to be worse for biological males with breast cancer.
* Non English or non-Spanish speaking: Women who do not speak English or Spanish will be excluded since these women are not eligible for the DA.
* History of invasive breast cancer
* History ductal carcinoma in situ treated with radiation (since these women are generally not be eligible for radiation treatment)
* Women with Paget's disease because treatment options differ
* inflammatory breast cancer because treatment options differ
* Phyllodes tumor because treatment options differ.
* In hospice
* Surgeon not willing to participate

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

* Age \<70
* Biological males: Biological males will be excluded since the data informing the DA were obtained from studies of biological females and treatment recommendations and outcomes tend to be worse for biological males with breast cancer.
* Non English or non-Spanish speaking: Women who do not speak English or Spanish will be excluded since these women are not eligible for the DA. If the DA is found to be effective in English and Spanish we plan to have the DA professionally translated to other languages at the end of the trial. English and Spanish are the most common languages spoken by older women at our recruitment sites.
* History of invasive breast cancer
* History ductal carcinoma in situ treated with radiation (since these women are generally not be eligible for radiation treatment)
* Paget's disease inflammatory breast cancer
* Phyllodes tumor
* In hospice
* Surgeon not willing to participate

Aim 2 Participant Exclusion Criteria: Participants who will be included in Aim 2 participant surveys to learn patient reported outcomes

* Age \<70
* Biological males: Biological males will be excluded since the data informing our DA were obtained from studies of biological females and treatment recommendations and outcomes tend to be worse for biological males with breast cancer.
* Non English or non-Spanish speaking: Women who do not speak English or Spanish will be excluded since these women are not eligible for the DA.
* history of invasive breast cancer
* Women with history ductal carcinoma in situ treated with radiation (since these women are generally not be eligible for radiation treatment)
* Paget's disease
* Inflammatory breast cancer
* A phyllodes tumor.
* In hospice
* Surgeon not willing to participate
* Psychiatric illness situations that would limit compliance with study requirements
* History of dementia
* Incapacity for informed consent
* Surgeon not willing to have patient complete study surveys
* 19 patients already successfully recruited that month and the patient is non-Hispanic white.

Primary Caregiver Exclusion Criteria:

* Age \<18
* Non-English and non-Spanish speaking
* Psychiatric illness situations that would limit compliance with study requirements

Allied health professionals (Aim 4 at the end of the trial) Exclusion Criteria:

* A trainee
* Psychiatric illness situations that would limit compliance with study requirements

Primary outcomes:
measure: Receipt of aggressive treatment within 6 months of First Surgical Encounter (Arm A)
timeFrame: 6 months
measure: Receipt of aggressive treatment within 6 months of First Surgical Encounter (Arm D)
timeFrame: 6 months
Secondary outcomes:
measure: Participant Perceived Shared Decision Making Quality Scale Score (Arm A)
timeFrame: at 1 week and at 6 months
measure: Participant Perceived Shared Decision Making Quality Scale Score (Arm D)
timeFrame: at 1 week and at 6 months
measure: Participant Decisional Conflict Scale Score (Arm A)
timeFrame: 1 week
measure: Participant Decisional Conflict Scale Score (Arm D)
timeFrame: 1 week
measure: Participant Knowledge Score at 1 week (Arm A)
timeFrame: 1 week
measure: Participant Knowledge Score at 6 Months (Arm A)
timeFrame: 6 months
measure: Participant Knowledge Score at 1 week (Arm D)
timeFrame: 1 week
measure: Participant Knowledge Score at 6 Months (Arm D)
timeFrame: 6 months
measure: Subjective Financial Distress Index Score (Arm A)
timeFrame: 6 months
measure: Subjective Financial Distress Index Score (Arm D)
timeFrame: 6 months
measure: EuroQol EQ-5D-5L Scale Score (Arm A)
timeFrame: 1 week and 6 months
measure: EuroQol EQ-5D-5L Scale Score (Arm D)
timeFrame: 1 week and 6 months
measure: Change in Surgeon Self-Efficacy Scale Score from Baseline to End of Study (Arm B)
timeFrame: Baseline and at end of the study. End of study will vary from 6 months to 4 years
measure: Change in Surgeon Self-Efficacy Scale Score from Baseline to End of Study (Arm E)
timeFrame: Baseline and at end of the study. End of study will vary from 6 months to 4 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Hospital and Medical Center
state: Massachusetts
city: Needham
country: United States
facility: Beth Israel Deaconess Hospital
state: Massachusetts
city: Weymouth
country: United States
facility: Dana-Farber/Brigham and Women's Cancer Center at South Shore Hospital
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Mara Schonberg, MD
role: PRINCIPAL_INVESTIGATOR
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