Decision Aid for Breast Cancer

(SDMPOSSIBLE Trial)

Recruiting at 5 trial locations

Overseen By Mara Schonberg, MD

Age: 65+

Sex: Female

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

402 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Decision Aid for breast cancer?

Research shows that decision aids help patients with breast cancer make informed choices about their treatment by providing clear information and involving them in the decision-making process. This can lead to better satisfaction with their treatment decisions and improved quality of life. ^{1 2 3 4 5}

Is the Decision Aid treatment safe for humans?

The research articles focus on the development and use of decision aids to help breast cancer patients make informed treatment choices, but they do not provide specific safety data about the decision aids themselves. ^{1 2 4 5 6}

How does the Decision Aid treatment for breast cancer differ from other treatments?

The Decision Aid for breast cancer is unique because it is a tool designed to help patients make informed choices about their surgical options, such as breast-conserving therapy or mastectomy, by providing clear, balanced information and reducing decisional conflict. Unlike traditional treatments, it focuses on patient involvement and understanding rather than a specific medical intervention. ^{2 3 4 5 7}

What is the purpose of this trial?

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.

Research Team

Mara Schonberg, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Development and evaluation of a decision aid for patients considering first-line chemotherapy for metastatic breast cancer. [2021]

2. England pubmed.ncbi.nlm.nih.gov

A decision aid to assist in adjuvant therapy choices for breast cancer. [2013]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Assessing the quality and communicative aspects of patient decision aids for early-stage breast cancer treatment: a systematic review. [2020]

4. United States 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. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluate the effectiveness of breast cancer decision aids: A systematic review and meta-analysis of randomize clinical trails. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Risk communication in a patient decision aid for radiotherapy in breast cancer: How to deal with uncertainty? [2021]

7. England pubmed.ncbi.nlm.nih.gov

Development of a patient decision aid for choice of surgical treatment for breast cancer. [2023]