Shared Decision-Making Toolkit for Breast Cancer

(I-MAMMO Trial)

Overseen By Rachel Freedman, MD, MPH

Age: 65+

Sex: Female

Trial Phase: Phase 2

Sponsor: Dana-Farber Cancer Institute

Must be taking: Hormonal therapy, CDK 4/6 inhibitors

Disqualifiers: Metastatic cancer, Hospice, Psychiatric illness, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a Shared Decision-Making (SDM) toolkit designed to assist breast cancer survivors aged 80 and above in deciding whether to continue regular mammograms. The study seeks to determine if this toolkit simplifies decision-making compared to usual care. Participants will either use the toolkit or follow their usual care routine, with feedback collected through surveys and interviews. This trial suits women aged 80 and above with a history of breast cancer who have had a mammogram in the past two years. As a Phase 2 trial, this research measures the toolkit's effectiveness in an initial, smaller group, offering participants a chance to contribute to improving decision-making tools.

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

The trial does not specify if you need to stop your current medications, but it does allow for hormonal therapy and CDK 4/6 inhibitor therapy. It's best to discuss your specific medications with the trial team.

What prior data suggests that the Shared Decision-Making Toolkit is safe for older breast cancer survivors?

Research has shown that tools for shared decision-making (SDM) are generally safe and helpful in medical settings. Past studies have demonstrated that these tools engage patients more in their care, leading to better decisions. No reports of harm or negative effects have emerged from using these toolkits.

This particular toolkit assists older breast cancer survivors in making informed choices about ongoing mammography (breast imaging) screenings. It enhances communication between patients and doctors. Since the toolkit involves no drugs or medical procedures, it is considered very low-risk. Overall, it supports thoughtful conversation, making it a safe option for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Shared Decision-Making (SDM) Toolkit for breast cancer treatment because it empowers patients to play an active role in their healthcare decisions. Unlike standard care, which often involves clinicians making most decisions, the SDM Toolkit facilitates a collaborative approach between patients and doctors. It aims to improve patient satisfaction and outcomes by ensuring that treatment choices align more closely with patient values and preferences. This toolkit could revolutionize how patients experience their treatment journey, making it more personalized and supportive.

What evidence suggests that the Shared Decision-Making Toolkit is effective for breast cancer survivors?

Research has shown that shared decision-making (SDM) tools assist breast cancer patients in making informed choices. These tools have been linked to positive outcomes, such as reduced regret and improved involvement in health decisions. Studies have also found that SDM can lessen feelings of conflict and depression during breast cancer treatment. In this trial, participants in the Shared Decision-Making Toolkit arm will use these tools during doctor visits, which has been shown to increase patient participation. The SDM toolkit aims to help older breast cancer survivors make well-informed decisions about their care. Meanwhile, participants in the Usual Care arm will continue with standard care practices without the SDM toolkit. ^{1 3 6 7 8}

Who Is on the Research Team?

Rachel Freedman, MD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for breast cancer survivors who are 80 years or older. It's designed to help them decide if they should continue with regular mammogram check-ups.

Inclusion Criteria

Receiving at least some of their oncology follow-up care at a participating site

I am a woman aged 80 years or older.

I have at least one intact breast.

Exclusion Criteria

Breast or recent imaging findings requiring diagnostic testing at baseline

I was assigned male at birth.

Psychiatric illness situations that would limit compliance with study requirements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are placed into either the Usual Care group or the Shared-Decision Making Toolkit group, with standard care visits and post-visit surveys conducted annually

2 years

2 visits per year (in-person)

Follow-up

Participants are monitored for knowledge, decisional quality, and mammography rates

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Shared Decision-Making Toolkit

Trial Overview The study is testing a Shared Decision-Making (SDM) toolkit, which aims to provide these seniors with the information and support needed to make informed choices about their ongoing cancer surveillance.

How Is the Trial Designed?

Group I: Shared-Decision Making Toolkit Experimental Treatment 1 Intervention

Enrolled participants will complete: * Year 1 standard of care visit with clinician followed by post-visit survey * Optional semi-structured interview with study staff * Year 2 standard of care visit with clinician followed by post-visit survey * Optional semi-structured interview with study staff * End of study survey

Group II: Usual Care Active Control 1 Intervention

Enrolled participants will continue with standard care practices without the SDM toolkit and will complete: * Year 1 standard of care visit with clinician followed by post-visit survey * Year 2 standard of care visit with clinician followed by post-visit survey * Optional semi-structured interview with study staff

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29747628/

The Availability and Effectiveness of Tools Supporting ... Background: Shared decision-making (SDM) in the management of metastatic breast cancer care is associated with positive patient outcomes. In ...

2. hipxchange.org hipxchange.org/toolkit/screeningmammo/

Breast Cancer Screening Shared Decision Making Toolkit This toolkit will enable clinicians to engage more effectively with patients when discussing breast cancer screening.

3. bmcpalliatcare.biomedcentral.com bmcpalliatcare.biomedcentral.com/articles/10.1186/s12904-018-0330-4

The availability and effectiveness of tools supporting shared ... Shared decision-making (SDM) in the management of metastatic breast cancer care is associated with positive patient outcomes.

4. 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.

5. thegreenjournal.com thegreenjournal.com/article/S0167-8140(24)00036-7/fulltext

Shared decision making with breast cancer patients Shared decision making supported by an in-consultation patient decision aid increased patient engagement in decision making.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9470011/

Definition of a tool to assess shared decision‐making ... It constitutes a quantitative instrument to integrate patient centeredness with a personalized perspective in the care management of women with breast cancer.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0959804924017143

Shared decision-making supported by outcome information ... The implementation of the BCS-PtDA, which integrates outcome information, led to increased patient-reported SDM and an improved quality of decision-making.

8. ascopubs.org ascopubs.org/doi/10.1200/EDBK_389516

Shared Decision Making in the Care of Patients With Cancer Shared decision making (SDM) is a method of care that is suitable for the care of patients with cancer. It involves a collaborative conversation seeking to ...