Patient-Specific Decision Aid System for Shared Decision Making About Breast Reconstruction
Evaluation of a Patient-Specific Decision Aid System for Shared Decision-Making About Breast Reconstruction
3 other identifiers
interventional
35
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 13, 2020
CompletedFirst Submitted
Initial submission to the registry
September 9, 2021
CompletedFirst Posted
Study publicly available on registry
November 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 2, 2027
March 5, 2026
March 1, 2026
6.3 years
September 9, 2021
March 3, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Length of consultation visit
up to 90 minutes
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
Study Arms (2)
Arm I (educational materials, enhanced consult, decision aid)
EXPERIMENTALPatients 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 (educational materials, standard of care consultation)
ACTIVE COMPARATORPatients 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.
Interventions
Attend an enhanced consultation with decision aid
Attend standard of care consultation
Undergo 2D and 3D torso imaging
Receive educational materials
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)collaborator
- M.D. Anderson Cancer Centerlead
- National Institutes of Health (NIH)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory Reece
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2021
First Posted
November 23, 2021
Study Start
October 13, 2020
Primary Completion (Estimated)
February 2, 2027
Study Completion (Estimated)
February 2, 2027
Last Updated
March 5, 2026
Record last verified: 2026-03