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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-13

Study Completion Date

2027-02-02

Brief Summary

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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.

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Detailed Description

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PRIMARY OBJECTIVE:

I. To evaluate a newly-developed computer application designed to facilitate shared decision making about breast reconstruction for practicability and usability.

SECONDARY OBJECTIVES:

I. To evaluate the effect of the decision aid application measured as the patient's decisional conflict, decision regret, and psychosocial well-being.

II. To evaluate the accuracy of predicted breast reconstruction outcomes to enhance the mathematical and physics-based algorithms for future use.

EXPLORATORY OBJECTIVE:

I. To evaluate patients' aesthetic measures, such as symmetry, breast volume, breast contour and ptosis 3 months after surgery.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: 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.

ARM II: 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.

Conditions

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Breast Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Arm I (educational materials, enhanced consult, decision aid)

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 Type EXPERIMENTAL

Enhanced Consultation

Intervention Type OTHER

Attend an enhanced consultation with decision aid

Conventional Imaging

Intervention Type PROCEDURE

Undergo 2D and 3D torso imaging

Educational Intervention

Intervention Type OTHER

Receive educational materials

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Arm II (educational materials, standard of care consultation)

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.

Group Type ACTIVE_COMPARATOR

Standard of Care Consultation

Intervention Type OTHER

Attend standard of care consultation

Conventional Imaging

Intervention Type PROCEDURE

Undergo 2D and 3D torso imaging

Educational Intervention

Intervention Type OTHER

Receive educational materials

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Enhanced Consultation

Attend an enhanced consultation with decision aid

Intervention Type OTHER

Standard of Care Consultation

Attend standard of care consultation

Intervention Type OTHER

Conventional Imaging

Undergo 2D and 3D torso imaging

Intervention Type PROCEDURE

Educational Intervention

Receive educational materials

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Consult Consultation Conventional CT Conventional MRI Conventional US Education for Intervention Intervention by Education Intervention through Education Intervention, Educational

Eligibility Criteria

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Inclusion Criteria

* MD Anderson patients, age 21 or older
* 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
* Considering immediate breast reconstruction at MD Anderson
* Likely to be a suitable candidate for implant-based reconstruction and/or abdominal-tissue based reconstruction as determined by an MD Anderson Plastic Surgery faculty member
* Ambulatory and able to stand unassisted for two minutes (3D imaging system requirement)
* Ability to understand and read English without a translator

Exclusion Criteria

* Has had a prior consultation with a plastic surgeon to discuss breast reconstruction
* History of breast surgery (i.e., breast reduction, mastopexy, segmental mastectomy, augmentation, reconstruction, but not including biopsy)
* Planning to have a delayed breast reconstruction
* Adjuvant radiation of the breast is indicated at the time of enrollment
* Diagnosis consistent with psychosis (such as schizophrenia, schizoaffective disorder, major depressive disorder \[MDD\] with psychotic features or steroid induced psychosis) in the chart
* Diagnosis consistent with cognitive impairment such as dementia, cognitive changes with stroke or radiation therapy in the chart
* Documented personality disorder
* Presence of non-medical tattoo on the breast

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No