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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05130580
• Other study ID #: 2019-1176
• Secondary ID: NCI-2020-1152020
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 13, 2020
• Est. completion date: February 2, 2027

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: February 2, 2027
• Est. primary completion date: February 2, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms

Intervention

Other:
• Enhanced Consultation
Attend an enhanced consultation with decision aid
• Standard of Care Consultation
Attend standard of care consultation

Procedure:
• Conventional Imaging
Undergo 2D and 3D torso imaging

Other:
• Educational Intervention
Receive educational materials
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of consultation visit		up to 90 minutes
Primary	Participant's decisional conflict score-Questionnaires	Decisional conflict is measured using the Decisional Conflict Scale (DCS). Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict)	at 6 months post-operation

External Links

•   M.D. Anderson Cancer Center