Decision Aid for Breast Cancer

(SDMPOSSIBLE Trial)

Not yet recruiting at 5 trial locations

Overseen By Mara Schonberg, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Age <70, Males, Non-English/Spanish, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help women with breast cancer make better treatment choices by using decision aids (tools designed to assist in making informed choices) and training surgeons. The goal is to determine if these tools improve the quality of decisions and overall care. The trial includes two groups: one receives the decision aid and surgeon training, while the other follows usual care. Women who may be suitable for this trial are those aged 70 or older with early-stage, estrogen receptor-positive breast cancer (a type of tumor that grows with hormones) and have not had invasive breast cancer before. As an unphased trial, this study offers participants the opportunity to contribute to innovative approaches in breast cancer care.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this decision aid is safe for patients?

Research has shown that decision aids, like the one tested in this study, are generally safe and easy to use. These tools help patients understand their treatment options and make informed decisions. Studies have found that decision aids usually do not harm patients or cause negative effects.

For example, one study with 245 women using a decision aid reported no significant negative effects. Instead, the tool helped women feel more informed about their choices. Another study on decision aids for breast cancer prevention also found them helpful without any safety concerns.

Overall, decision aids are considered safe because they primarily provide information and support for decision-making, rather than involving medication or physical treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Decision Aid for Breast Cancer trial because it focuses on enhancing shared decision-making (SDM) between surgeons, patients, and caregivers. Unlike standard treatments, which mainly involve medical or surgical interventions, this approach aims to improve communication and decision-making processes in treatment planning. By using a structured decision aid, this trial seeks to empower patients and caregivers with more personalized and informed choices, potentially leading to better satisfaction and outcomes. This innovative focus on decision-making as part of the care process represents a significant shift from traditional practices, which often don't prioritize patient involvement to this extent.

What evidence suggests that this decision aid is effective for breast cancer treatment decisions?

Research has shown that decision aids, which help patients understand their choices, are effective in breast cancer care. In this trial, one group of surgeons will incorporate decision aids into their practice. Studies have found that these aids can reduce uncertainty and regret about decisions. They also help lower depression in patients undergoing breast reconstruction. Another study found that decision aids increase patient knowledge and satisfaction with their choices. These tools boost patients' confidence in their decisions, leading to better outcomes and less pain after surgery. ^{2 6 7 8 9}

Who Is on the Research Team?

Mara Schonberg, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for women aged 70 or older who have been diagnosed with low-risk Stage I breast cancer. It's designed to help them make treatment decisions using a special decision aid and training for surgeons.

Inclusion Criteria

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

I am a woman aged 70 or older with a small, early-stage, ER+ HER2- breast cancer.

I am a surgeon over 18, treating women 70+ at a participating practice and agree to give verbal consent.

Exclusion Criteria

Resident surgeon, non-surgeons, or those with psychiatric illness situations that would limit compliance with study requirements

Trainees or those with psychiatric illness situations that would limit compliance with study requirements for allied health professionals in Aim 4 at the end of the trial

I am not eligible if I am a biological male, don't speak English/Spanish, have certain breast conditions, am in hospice, have psychiatric illnesses, dementia, or if my surgeon won't participate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Preparation

Surgeons complete a 1-hour training in shared decision making and baseline survey

8 weeks

1 visit (virtual or in-person)

Patient Enrollment and Decision Aid Distribution

Eligible patients receive decision aids before their first surgical encounter

3 years

Ongoing patient interactions

Follow-up

Participants are monitored for treatment outcomes and shared decision making quality

6 months to 3.5 years

Surveys at 1 week and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Decision Aid

Trial Overview The study tests whether giving patients a decision aid and providing their surgeons with shared decision-making training can improve the quality of treatment decisions compared to usual care. The aids are sent through mail, patient portals, or email before the first surgery meeting.

How Is the Trial Designed?

Group I: Surgeons + SDM/DA Experimental Treatment 1 Intervention

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.

Group II: Standard-of-Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Published Research Related to This Trial

A decision aid (DA) prototype was developed and positively received by 12 women over 70 with Stage I breast cancer, indicating it is clear and acceptable for helping them understand treatment options.

Participants found the DA helpful for making treatment decisions and recommended its use in clinical practice, highlighting the need for better decisional support for older patients in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Working Toward a Decision: The Development and First Impressions of a Decision Aid for Older Women with Early-stage Breast Cancer. D'Alimonte, L., Angus, J., Wong, J., et al.[2019]

Decision aids significantly reduced treatment decision conflicts for breast cancer patients compared to conventional methods, indicating they can help patients feel more confident in their treatment choices.

However, decision aids did not significantly impact screening decision conflicts or other factors like anxiety, decision regret, and satisfaction, suggesting their effectiveness may be limited to specific decision-making scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluate the effectiveness of breast cancer decision aids: A systematic review and meta-analysis of randomize clinical trails. Gao, JP., Jin, YH., Yu, SF., et al.[2021]

The Adjuvant! decision aid significantly influenced treatment choices for breast cancer patients, with 13.3% of patients opting out of adjuvant therapy after using the tool, indicating its effectiveness in facilitating informed decision-making.

Over 95% of patients found the decision aid easy to understand, and 81.4% of physicians reported it was useful for understanding patient preferences, highlighting its acceptability and potential to enhance patient-physician communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A decision aid to assist in adjuvant therapy choices for breast cancer. Siminoff, LA., Gordon, NH., Silverman, P., et al.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12409458/

Shared decision-making for early-stage breast cancer ... Objective. The lack of a clear and unified definition of shared decision-making (SDM) may hinder its effective application in oncology care.

2. sciencedirect.com sciencedirect.com/science/article/pii/S234756252400218X

Effect of shared decision-making in patients with breast ... SDM shows positive effects in many aspects in patients with breast reconstruction, including reducing decisional conflict, decisional regret, and depression.

3. abs.amegroups.org abs.amegroups.org/article/view/8993/html

Improving value-concordant shared decision making through ... In breast cancer surgical care, pDAs have been shown to increase patient knowledge, improve patient satisfaction with decision, lower pain scores, and improve ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2809976

Effectiveness of a Decision Aid Plus Standard Care in ... This randomized clinical trial evaluates the effect of a decision-making aid and patient preference assessment tool in surgical ...

5. bmcwomenshealth.biomedcentral.com bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-025-03754-8

Effects of a web-based decision aid on breast cancer patients ... The current study demonstrated that WDAs effectively improved decision satisfaction in patients requiring breast cancer surgery, a finding ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9706380/

Supporting Shared Decision-making About Surveillance After ... This study aimed to develop a patient decision aid (PtDA), integrating personalized risk calculations on risks for recurrences, to support SDM for personalized ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06896474

SDM POSSIBLE: A Breast Cancer Treatment Decision Aid ... Research staff will review the medical records for all participants with eligible tumor and study characteristics seen by a participating surgeon during the ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0960977623007397

Development and evaluation of a decision aid for women ... Decision aids (DA) can help individuals gain knowledge about breast screening to enable them to make informed decisions consistent with their personal ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5060163/

Development and evaluation of a breast cancer prevention ... Objective To develop and evaluate the effectiveness of a breast cancer prevention decision aid for women aged 50 and older at higher risk of breast cancer.