35 Participants Needed

Decision Aid for Breast Reconstruction After Cancer

GR
Overseen ByGregory Reece
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Patient-Specific Decision Aid System for breast reconstruction after cancer?

Research shows that decision aids help women considering breast reconstruction after mastectomy by reducing confusion and increasing satisfaction with their decisions. These aids improve the decision-making process and align choices with personal values, leading to better health outcomes.12345

Is the decision aid for breast reconstruction safe for humans?

The research articles focus on the effectiveness of decision aids in improving decision-making and satisfaction for breast reconstruction, but they do not provide specific safety data for humans.12356

How does the decision aid for breast reconstruction differ from other treatments?

The decision aid for breast reconstruction is unique because it helps women make informed choices about their surgery options by providing personalized information and support, reducing stress and regret associated with the decision-making process. Unlike traditional treatments, this tool focuses on shared decision-making, ensuring that patients' values and preferences are considered in their surgical choices.23457

What is the purpose of this trial?

This clinical trial evaluates whether a decision aid application (app) is effective in helping breast reconstruction surgery patients make informed decisions about breast reconstruction surgery. Researchers have created a computer app for breast reconstruction surgery patients that presents images of breast reconstruction outcomes that are customized to the individual patient's treatment options and personal preferences. This decision aid app may help educate patients about how they might look after surgery and answer their questions.

Research Team

GR

Gregory Reece

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.
See 3 more

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.
See 5 more

Timeline

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)

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (educational materials, enhanced consult, decision aid)Experimental Treatment4 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 Control4 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.

Find a Clinic Near You

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+

References

Efficacy of a decision aid in breast cancer patients considering immediate reconstruction: results of a randomized controlled trial. [2023]
Pre-consultation educational group intervention to improve shared decision-making for postmastectomy breast reconstruction: a pilot randomized controlled trial. [2022]
Breast Reconstruction Decision Aids Decrease Decisional Conflict and Improve Decisional Satisfaction: A Randomized Controlled Trial. [2023]
Feasibility and Efficacy of Decision Aids to Improve Decision Making for Postmastectomy Breast Reconstruction: A Systematic Review and Meta-analysis. [2022]
Development and implementation of a decision aid for post-mastectomy breast reconstruction for Japanese women with breast cancer: a field-testing study. [2023]
Patient-Reported Outcomes of Breast Reconstruction: Does the Quality of Decisions Matter? [2023]
A Randomized Controlled Trial Evaluating the BREASTChoice Tool for Personalized Decision Support About Breast Reconstruction After Mastectomy. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security