Optimizing Decision Making About Breast Reconstruction After Mastectomy: A Patient-Centered Approach
Condition: Breast Cancer
Intervention: Usual care American Society of Plastic Surgeons booklet "Breast Reconstruction"; Decision tool; Usual Care Group - Outcome Measures; Decision Group - Outcome Measures; Demographic and Background Questions
Intervention description: -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
Phase: Phase 1
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        -  Newly diagnosed or recurrent breast cancer

          -  Considering a referral or already referred to a plastic surgeon by their surgical
             oncologist for possible reconstruction

          -  Considering or completing a mastectomy.

          -  Does not have known distant metastatic disease (stage IV disease) at the time of
             recruitment

          -  Female.

          -  English-speaking.

          -  At least 18 years of age.

          -  Able to understand and willing to sign an IRB-approved written informed consent
             document.