Optimizing Decision Making About Breast Reconstruction After Mastectomy: A Patient-Centered Approach

PHASE1CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

January 9, 2018

Primary Completion Date

October 24, 2018

Study Completion Date

October 24, 2018

Conditions
Breast Cancer
Interventions
OTHER

"Usual care American Society of Plastic Surgeons booklet Breast Reconstruction"

-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

OTHER

Decision tool

-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

OTHER

Usual Care Group - Outcome Measures

"* 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."

OTHER

Decision Group - Outcome Measures

"* 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)."

OTHER

Demographic and Background Questions

"* 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"

Trial Locations (1)

63110

Washington University School of Medicine, St Louis

All Listed Sponsors
lead

Washington University School of Medicine

OTHER

NCT03346161 - Optimizing Decision Making About Breast Reconstruction After Mastectomy: A Patient-Centered Approach | Biotech Hunter | Biotech Hunter