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

March 25, 2024 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Questionnaire Administration
Ancillary studies
Other: Educational Intervention
Receive educational materials
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Other: Enhanced Consultation
Attend an enhanced consultation with decision aid
Other Names:
  • Consult
Procedure: Conventional Imaging
Undergo 2D and 3D torso imaging
Other Names:
  • Conventional MRI
  • Conventional CT
  • Conventional US
Active Comparator: 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.
Other: Questionnaire Administration
Ancillary studies
Other: Educational Intervention
Receive educational materials
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Procedure: Conventional Imaging
Undergo 2D and 3D torso imaging
Other Names:
  • Conventional MRI
  • Conventional CT
  • Conventional US
Other: Standard of Care Consultation
Attend standard of care consultation
Other Names:
  • Consultation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of consultation visit
Time Frame: up to 90 minutes
up to 90 minutes
Participant's decisional conflict score-Questionnaires
Time Frame: at 6 months post-operation
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Gregory Reece, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2020

Primary Completion (Estimated)

February 2, 2027

Study Completion (Estimated)

February 2, 2027

Study Registration Dates

First Submitted

September 9, 2021

First Submitted That Met QC Criteria

November 10, 2021

First Posted (Actual)

November 23, 2021

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-1176 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2020-11520 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • R01CA203984 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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