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Decision Aid for Breast Reconstruction After Cancer

N/A

Waitlist Available

Led By Gregory Reece

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planning to undergo either a unilateral or bilateral total, skin-sparing or nipple-sparing mastectomy; or, planning to undergo a unilateral or bilateral modified radical mastectomy

MD Anderson patients, age 21 or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 months post-operation

Awards & highlights

Study Summary

This trial is testing whether a computer app can help patients make informed decisions about breast reconstruction surgery by presenting images of possible outcomes customized to the individual patient.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves an educational intervention rather than medication or invasive procedures, traditional side effects aren't applicable. However, there may be psychological impacts from viewing potential post-surgery outcomes which could influence patient decisions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I can stand by myself for at least two minutes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 months post-operation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 months post-operation

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months post-operation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Length of consultation visit

Participant's decisional conflict score-Questionnaires

Trial Design

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,767 Total Patients Enrolled

148 Trials studying Breast Cancer

63,286 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,632 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,544 Total Patients Enrolled

50 Trials studying Breast Cancer

110,785 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are further enrollees being accepted into this clinical investigation?

"Affirmative. Clinicaltrials.gov details that this experiment, which debuted on October 13th 2020, is still in the recruitment process. 40 individuals are required to join at one medical facility."

Answered by AI

How many individuals have been recruited for this research project?

"Affirmative. According to the clinicaltrials.gov data, this medical experiment is still in need of participants. It was first introduced on October 13th 2020 and edited most recently on November 10th 2021. The research team needs 40 individuals from a solitary centre to partake."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Patient-Specific Decision Aid System for Shared Decision Making About Breast Reconstruction

2020. "Patient-Specific Decision Aid System for Shared Decision Making About Breast Reconstruction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05130580.