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

Phase 1

Completed

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

• Registration Number: NCT03346161
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-01
• Study First Submitted QC: 2017-11-14
• Study First Posted: 2017-11-17
• Study Start: 2018-01-09
• Primary Completion: 2018-10-24
• Study Completion: 2018-10-24
• Results First Submitted: 2019-05-08
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-26
• Last Update Submitted: 2019-07-26
• Results First Posted: 2019-09-06
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: BREASTChoice (Decision Tool)	Decision Group - Outcome Measures	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.
Arm 1: BREASTChoice (Decision Tool)	Demographic and Background Questions	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.
Arm 2: Enhanced Usual Care (Surgical Care Booklet)	Usual Care Group - Outcome Measures	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.
Arm 1: BREASTChoice (Decision Tool)	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.
Arm 2: Enhanced Usual Care (Surgical Care Booklet)	Usual care American Society of Plastic Surgeons booklet "Breast Reconstruction"	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.
Arm 2: Enhanced Usual Care (Surgical Care Booklet)	Demographic and Background Questions	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.

Primary Outcome Measures

Name	Time	Method
Decision Process (Decision Quality Index Subscale)	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
Decisional Conflict (SURE Measure)	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
Percent Correct on the Knowledge Measure (Objective Knowledge Score)	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States