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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Decision tool; Other: Decision Group - Outcome Measures; Other: Demographic and Background Questions; Other: Usual care American Society of Plastic Surgeons booklet "Breast Reconstruction"; Other: Usual Care Group - Outcome Measures

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm 1: BREASTChoice (Decision Tool); Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes.	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: 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
ACTIVE_COMPARATOR: Arm 2: Enhanced Usual Care (Surgical Care Booklet); Investigators recruited patients scheduled for plastic/reconstruction consultation. Investigators identified patients who completed or scheduled a mastectomy, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or to complete the pre-appointment procedures at home. Patients were randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with American Society of Plastic Surgeons booklet "Breast Reconstruction." They were asked to answer a survey. After the appointment, the team collected information about consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes.	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; 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Correct on the Knowledge Measure (Objective Knowledge Score)	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	Through completion of breast consultation appointment (total participant time approximately 30 minutes)
Decisional Conflict (SURE Measure)	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	Through completion of breast consultation appointment (total participant time approximately 30 minutes)
Decision Process (Decision Quality Index Subscale)	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	Through completion of breast consultation appointment (total participant time approximately 30 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life as Measured by the BREAST-Q Questionnaire	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.	Through completion of breast consultation appointment (total participant time approximately 30 minutes)
Gold Standard Shared Decision Making as Measured by the Top collaboRATE Score	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.	Through completion of breast consultation appointment (total participant time approximately 30 minutes)
Patient Activation (PAM) as Measured by the Number of Participants Who Agreed With Each Statement	-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)	Through completion of breast consultation appointment (total participant time approximately 30 minutes)
Receipt of Reconstruction	Assessed if participants received reconstruction	Through follow-up (approximately 6 months)
Type of Reconstruction	Assessed what type of reconstruction participants received	Through completion of follow-up (approximately 6 months)
Timing of Reconstruction	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	Through completion of follow-up (approximately 6 months)
Time Spent on Tool	How long participants spent on the BREASTChoice tool	Through completion of breast consultation appointment (total participant time approximately 30 minutes)
Consult Time	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)	Through completion of breast consultation appointment (total participant time approximately 30 minutes)
Usability as Measured by the Computer System Usability Questionnaire (CSUQ)	Assessed ease of usability of the BREASTChoice tool; Scale is from 1 (strongly disagree) to 7 (strongly agree)	Through completion of breast consultation appointment (total participant time approximately 30 minutes)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Mary C Politi, Ph.D., MPH, Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 9, 2018
• Primary Completion (ACTUAL): October 24, 2018
• Study Completion (ACTUAL): October 24, 2018

Study Registration Dates

• First Submitted: November 1, 2017
• First Submitted That Met QC Criteria: November 14, 2017
• First Posted (ACTUAL): November 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 6, 2019
• Last Update Submitted That Met QC Criteria: July 26, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 201701045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No