At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Optimizing Decision Making About Breast Reconstruction After Mastectomy: A Patient-Centered Approach
In Brief
A Phase 1 clinical trial evaluating Usual care American Society of Plastic Surgeons booklet "Breast Reconstruction", Decision tool, and 3 other interventions for Breast Cancer. Completed, enrolled 120 participants across 1 site.
Detailed Summary
Although clinical decision tools (CDTs) exist for a variety of treatments, CDTs designed to support personalized breast reconstruction decisions, particularly about type and timing of reconstruction, are lacking. The objective of this proposal is to develop and pilot test a clinical decision tool that provides personalized risk information and reflects patients' preferences and clinical needs.
Study Details
Timeline
Interventions
-Booklet from the American Society of Plastic Surgeons about how to choose a breast reconstruction surgeon, what to expect during surgery, what is breast reconstruction, risks of breast reconstruction, recovery, costs, and questions to ask surgeon about breast reconstruction
-Interactive web based tool. Provides detail about breast reconstruction, asks participant questions about health and medications to personalize risks for breast reconstruction outcome. The tool also goes into pros/cons of breast reconstruction, talks about differences between types of reconstruction, helps people weigh when to have reconstruction (immediate vs. delayed), shows participants representative photos of breast reconstruction outcomes, and assesses patients' knowledge and preferences
* Section 1 Knowledge (primary outcome) - set of multiple choice questions about breast reconstruction, implants, flap surgeries, and side effects * Section 2 Decisional Conflict Scale - 4 questions with yes/no answers dealing with participant's certainty about surgery (it total score less than 4, indicates higher decisional conflict) * Section 3 Patient Activation Measures: 3 yes/no questions about participant's knowledge and trust of healthcare provider, sources of info about breast reconstruction, and different options available * Section 4 Breast Reconstruction Decision Quality Instrument: 18 multiple choice questions about thought and processes that went into deciding about breast reconstruction * Section 5 BREAST-Q: 3 questions about the breast reconstruction consultation appoint answers range from 0=no effort to 9=every effort.
* Section 1 Knowledge and Values Clarification Questions - set of multiple choice questions about the participants feelings on breast reconstruction, implants, flap surgeries, and side effects * Section 2 Decisional Conflict SURE measure - 4 questions with yes/no answers dealing with participant's conflicts on surgery (if total score less than 4, indicates higher clinical significant decisional conflict) * Section 3 Patient Activation Measures: 3 yes/no questions about participant's knowledge and trust of healthcare provider, sources of info about breast reconstruction, and different options available * Section 4 Breast Reconstruction Decision Quality Instrument: 18 multiple choice questions about thought and processes that went into deciding about breast reconstruction (for those who have a clinical visit) * Section 5 BREAST-Q: 3 questions about the breast reconstruction consultation appointment answers range from 0=no effort to 9=every effort (for those who have a clinical visit).
* Asks 15 questions * Age, education, ethnicity, race, combined household income, zip code, disease stage, (3) questions about health insurance, (4) questions about participant's ability to work with numbers, heath literacy, health insurance status, and (1) question on if participant spoke to another provider about breast reconstruction decision