Decision Aid for Breast Reconstruction After Cancer

Overseen By Gregory Reece

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Prior breast surgery, Psychosis, Cognitive impairment, Personality disorder, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new decision aid app designed to help breast cancer patients make informed choices about reconstruction surgery. The app displays personalized images of potential outcomes based on each patient's treatment options and preferences. Participants will view how they might look after surgery and complete surveys on their decision-making and well-being. The trial seeks MD Anderson patients planning immediate breast reconstruction who can stand unassisted for two minutes. As an unphased trial, it offers patients the chance to contribute to innovative tools that could enhance decision-making for future breast cancer patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a decision aid app for surgery planning, so it's unlikely to require changes to your medication.

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

Research has shown that decision aid apps, such as the one tested in this trial for breast reconstruction surgery, are generally safe. Studies have found that these apps assist patients in making informed choices by providing personalized information about surgery options. No reports of negative effects exist from using these apps, as they serve as educational tools rather than medications or physical treatments. Consequently, they are user-friendly, offering guidance without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to support decision-making in breast reconstruction after cancer. Unlike the current standard of care, which typically involves standard consultations, this trial introduces a patient-specific decision aid system. This system provides a personalized presentation of breast reconstruction options using educational materials and enhanced consultations, potentially improving patient satisfaction and psychological well-being. By incorporating both 2D and 3D imaging, the trial aims to offer a more comprehensive view of potential outcomes, helping patients make more informed choices.

What evidence suggests that this decision aid app is effective for breast reconstruction decision-making?

Research shows that decision aid apps can help patients make better choices about breast reconstruction surgery. In this trial, participants in one arm will receive an enhanced consultation with a decision aid application. Previous findings revealed that 72% of patients were satisfied with the decision aid, and 74% would recommend it to others. These tools allow patients to view personalized images of possible results, making it easier to understand what to expect. By providing detailed and personalized information, decision aids can improve decision-making and increase satisfaction with surgical outcomes. ^{1 3 6 7 8}

Who Is on the Research Team?

Gregory Reece

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for MD Anderson patients aged 21 or older who are planning to undergo mastectomy and immediate breast reconstruction. They must be able to stand unassisted, likely suitable for implant or abdominal-tissue based reconstruction, and read English without a translator. Excluded are those with certain psychiatric conditions, prior breast surgeries (except biopsy), planned adjuvant radiation at enrollment time, previous plastic surgery consultations for reconstruction, cognitive impairments, or tattoos on the breast.

Inclusion Criteria

An MD Anderson expert thinks I'm a good fit for implant or tissue-based breast reconstruction.

I am planning to have a mastectomy, with options for skin or nipple sparing.

I am a patient at MD Anderson and I am 21 years old or older.

Exclusion Criteria

You have a diagnosed personality disorder.

My condition is diagnosed as a type of psychosis, like schizophrenia or major depression with psychosis.

I plan to have breast reconstruction surgery at a later time.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Consultation and Decision Aid

Participants receive educational materials and attend a consultation visit with their plastic surgeon to discuss breast reconstruction options. A decision aid application is presented to assist in decision-making.

1 visit

1 visit (in-person)

Follow-up

Participants complete questionnaires about satisfaction, body image, and psychological well-being, and undergo 2D and 3D imaging of the torso.

6 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Patient-Specific Decision Aid System

Trial Overview The study tests an app designed as a decision aid for patients considering breast reconstruction surgery post-mastectomy. The app provides personalized images of potential surgical outcomes tailored to treatment options and patient preferences. It aims to assist in informed decision-making by showing how one might look after surgery.

How Is the Trial Designed?

Group I: Arm I (educational materials, enhanced consult, decision aid) Experimental Treatment 4 Interventions

Patients receive newly-developed educational materials about breast reconstruction and attend an enhanced consultation visit with their plastic surgeon to discuss options for breast reconstruction surgery, during which a decision aid application containing a customized presentation of possible breast reconstruction outcomes is presented. At the end of the consultation visit, patients complete questionnaires about decision-making and psychological well-being. Within 4-6 weeks and 3-6 months after beginning the reconstruction process, patients also complete questionnaires about satisfaction with their breasts, body image, and psychological well-being, and undergo two-dimensional (2D) and 3D imaging of the torso.

Group II: Arm II (educational materials, standard of care consultation) Active Control 4 Interventions

Patients receive newly-developed educational materials about breast reconstruction and attend a standard of care consultation visit with their plastic surgeon to discuss options for breast reconstruction surgery. At the end of the consultation visit, patients complete questionnaires about decision-making and psychological well-being. Within 4-6 weeks and 3-6 months after beginning the reconstruction process, patients also complete questionnaires about satisfaction with their breasts, body image, and psychological well-being, and undergo 2D and 3D imaging of the torso.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12485225/

Effectiveness of a patient decision aid for women ... This RCT evaluated whether an online patient decision aid provided additional benefits over high-quality standard care in supporting post- ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05130580

Patient-Specific Decision Aid System for Shared ... This clinical trial evaluates whether a decision aid application (app) is effective in helping breast reconstruction surgery patients make informed ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2096691125000445

A scoping review on the development of a decision-aid tool ... This review aims to explore the decision-making experiences and current status of SDM among cosmetic breast surgery patients, and to develop a ...

4. link.springer.com link.springer.com/article/10.1007/s10549-025-07752-0

Patient decision aids in breast surgery and ... This study systematically reviews breast surgery (BS) and breast reconstruction (BR) PDAs using the International Patient Decision Aid Standards ...

5. bmcmedinformdecismak.biomedcentral.com bmcmedinformdecismak.biomedcentral.com/articles/10.1186/s12911-024-02832-5

Patients' and plastic surgeons' experiences with an online ... Most patients (72%) were satisfied with the pDA and 74% would recommend the BR pDA to other women facing the same choice. Patients' preferences ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12060549/

Effects of a web-based decision aid on breast cancer patients ... The objective of this study was to determine the effects of WDAs on breast cancer patients considering a breast reconstruction.

7. prevention.cancer.gov prevention.cancer.gov/funding-and-grants/funded-grants/R01CA203984

Funded Grants | Division of Cancer Prevention This system for shared decision-making will use quantitative models to tailor the presentation of patient-specific information about breast reconstruction ...

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

Improving value-concordant shared decision making through ... In breast cancer surgery, pDAs help patients weigh the physical and emotional consequences between treatment options eg between breast conserving surgery (BCS) ...