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OpenTrials
Completed

NCT Number: NCT03346161

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

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

Other

-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

Decision tool

Other

-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

Usual Care Group - Outcome Measures

Other
  • 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.

Decision Group - Outcome Measures

Other
  • 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).

Demographic and Background Questions

Other
  • 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

Primary outcomes

  1. Percent Correct on the Knowledge Measure (Objective Knowledge Score)

    Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)

    To determine whether the CDT increases knowledge about their choice, the investigators will compare objective knowledge scores between participants using the CDT and those who received usual care

  2. Decisional Conflict (SURE Measure)

    Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)

    • To determine whether the CDT reduces uncertainty about choice. Participants are asked to report how sure they feel about their choice, if they have enough information to understand the choice, if they are clear about the risks and benefits, and if they have enough support to make a choice. Results are compared between the BREASTChoice and Enhanced Usual Care groups.
    • Higher SURE values indicate certainty in choice
    • Scores range from 0-4

  3. Decision Process (Decision Quality Index Subscale)

    Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)

    • The total points are summed and then divided by the total number of items to result in scores from 0-100%, with higher scores indicating a more shared decision making process
    • Assess the extent to which patients were meaningfully involved in decision-making with their clinicians

Secondary outcomes

  1. Quality of Life as Measured by the BREAST-Q Questionnaire

    Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)

    • Assessed 4 subscales: satisfaction with breasts, psychosocial well-being, physical well-being, and sexual well-being
    • Score from 0 (worst) to 100 (best). Higher scores reflect a better outcome.

  2. Gold Standard Shared Decision Making as Measured by the Top collaboRATE Score

    Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)

    • Top collaboRATE score = the percentage of patients from whom there was 'gold standard' shared decision making as assessed by the collaboRATE measure
    • The top score is coded as '1', if the response to all three collaboRATE items was less than 9. Then the investigators calculated the percentage of all encounters that were coded as '1' indicating gold standard shared decision making.

  3. Patient Activation (PAM) as Measured by the Number of Participants Who Agreed With Each Statement

    Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)

    -3 questions consisting of the following:

    • I am confident I can tell my healthcare provider concerns that I have about breast reconstruction even when he or she does not ask (confidence in healthcare provider)
    • I am confident I can find trustworthy sources of information about my breast reconstruction decision (confidence in trustworthy sources)
    • I know the different options available for breast reconstruction (knowledge on breast reconstruction options)

  4. Receipt of Reconstruction

    Time frame: Through follow-up (approximately 6 months)

    Assessed if participants received reconstruction

  5. Type of Reconstruction

    Time frame: Through completion of follow-up (approximately 6 months)

    Assessed what type of reconstruction participants received

  6. Timing of Reconstruction

    Time frame: Through completion of follow-up (approximately 6 months)

    • Assessed timing of reconstruction
    • Immediate is defined as reconstruction at the time of mastectomy
    • Delayed is defined as reconstruction any time after the mastectomy and performed as a separate surgery

  7. Time Spent on Tool

    Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)

    How long participants spent on the BREASTChoice tool

  8. Consult Time

    Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)

    Assessed the time between when the plastic/reconstructive surgeon entered and exited the consult room (not including time spent with a resident, nurse, or other clinical staff)

  9. Usability as Measured by the Computer System Usability Questionnaire (CSUQ)

    Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)

    • Assessed ease of usability of the BREASTChoice tool
    • Scale is from 1 (strongly disagree) to 7 (strongly agree)

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 17, 2017
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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