Decision Aid Tool for Breast Cancer

(BREASTChoice Trial)

Overseen By Kathryn A Chetwynd

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Unstable medical, psychiatric conditions

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

Compensation: Varies

Number of Visits: 1

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool, BREASTChoice, designed to help breast cancer survivors make informed care decisions. The focus is on the tool's ease of use and helpfulness on mobile devices. Participants will share their thoughts while using the tool, and their feedback will improve its design and function. Individuals who have undergone breast surgery due to breast cancer in the last eight years and can read and speak English may be suitable for this study. As an unphased trial, this study allows participants to contribute to developing a tool that could significantly aid breast cancer survivors in making informed care decisions.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on evaluating a decision aid tool rather than medical treatments.

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

Research has shown that the BREASTChoice decision aid is safe and easy for users to handle. It has been tested in several studies with breast cancer survivors. These studies found that the tool helps patients understand their options for breast reconstruction.

As a decision aid, the BREASTChoice tool does not involve taking medicine or undergoing procedures, reducing the risk of physical side effects. Instead, it focuses on providing information and clarifying treatment choices. Patients who used the tool reported feeling more informed and less uncertain about their decisions.

Overall, the tool appears easy to use and helpful, with no reports of negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

BREASTChoice is unique because it offers a personalized decision aid tool specifically for breast cancer survivors. Unlike standard treatments, which focus on medical or surgical interventions, this tool empowers patients by helping them make informed choices tailored to their individual circumstances and preferences. Researchers are excited about BREASTChoice because it prioritizes patient engagement and personalized care, potentially improving satisfaction and outcomes for those navigating life after breast cancer.

What evidence suggests that this decision aid tool is effective for breast cancer patients?

Research shows that the BREASTChoice decision tool, used by participants in this trial, helps breast cancer survivors make informed care choices. Tested in several studies, it successfully fills knowledge gaps for patients. The tool educates users about breast reconstruction and provides personalized risk estimates for complications. Studies have found that patients using BREASTChoice feel more informed and involved in their treatment decisions. Overall, evidence supports that BREASTChoice improves patient knowledge and decision-making. ^{1 2 6 7 8}

Who Is on the Research Team?

Clara Lee

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for breast cancer patients who are willing to use a decision aid tool on their mobile devices and provide feedback. Participants will be asked to share their thoughts while using the tool and answer questions about its design, comprehension, and usability.

Inclusion Criteria

I have had surgery to remove part or all of my breast.

I had breast surgery within the last 8 years.

I am 18 years old or older.

Exclusion Criteria

Individuals with self-reported or observed unstable medical or psychiatric conditions precluding informed consent or participation in the study will be excluded.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Usability Testing

Participants use the BREASTChoice tool on mobile devices and provide feedback through a 'think-aloud' method and interviews.

1 week

1 visit (in-person or virtual)

Follow-up

Participants are monitored for changes in breast reconstruction knowledge using the Decision Quality Instrument.

1 week

What Are the Treatments Tested in This Trial?

Interventions

• BREASTChoice

Trial Overview

The study is testing the usability of a new decision aid tool designed for breast cancer patients. It involves observing participants as they interact with the tool, followed by interviews and surveys to evaluate their experience.

How Is the Trial Designed?

Group I: Breast cancer survivors Experimental Treatment 3 Interventions

Breast cancer survivors.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11599463/

A Randomized Controlled Trial of the Implementation of ... - PMC

BREASTChoice, is a multilevel decision tool that: 1) educates patients about breast reconstruction; 2) estimates personalized risk of complications; 3) ...

2.

trialx.com

trialx.com/clinical-trials/listings/300485/breast-choice-decision-tool-r21/

BREAST Choice Decision Tool R21

The BREASTChoice decision aid, proven effective in two randomized controlled trials, addresses knowledge gaps in breast cancer survivors.

3.

journals.lww.com

journals.lww.com/annalsofsurgery/abstract/9900/a_randomized_controlled_trial_of_the.905.aspx

A Randomized Controlled Trial of the Implementation of...

BREASTChoice is a novel decision tool incorporating risk prediction, patient education, and clinician engagement. Patients using BREASTChoice ...

4.

profiles.wustl.edu

profiles.wustl.edu/en/publications/a-randomized-controlled-trial-of-the-implementation-of-breastchoi/

A Randomized Controlled Trial of the Implementation ...

Objective: To implement the BREASTChoice decision tool into the electronic health record and evaluate its effectiveness.

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04491591

NCT04491591 | Implementing BREASTChoice Into Practice

This randomized control trial will evaluate whether the implementation of BREASTChoice into routine care delivery is more effective than a control website, at ...

6.

breastchoice.wustl.edu

breastchoice.wustl.edu/

Home | B.R.E.A.S.T. Choice Study | Washington University in ...

This multi-site randomized controlled trial is implementing a decision support tool called BREASTChoice and testing its effectiveness in clinical practice.

7.

journals.sagepub.com

journals.sagepub.com/doi/10.1177/23814683211042010

Implementing an Electronic Clinical Decision Support Tool ...

To explore barriers and facilitators to implementing an evidence-based clinical decision support (CDS) tool (BREASTChoice) about post-mastectomy breast ...

8.

link.springer.com

link.springer.com/article/10.1186/s12905-025-03754-8

Effects of a web-based decision aid on breast cancer patients ...

Our findings indicate that WDAs have a positive effect on alleviating decisional conflict and can help patients use limited time to weigh the ...