Trial Outcomes & Findings for Implementing BREASTChoice Into Practice (NCT NCT04491591)
NCT ID: NCT04491591
Last Updated: 2024-08-12
Results Overview
-The validated Breast Reconstruction Decision Quality Instrument (DQI) knowledge scale contains 9 items on key facts about reconstruction. A value of 1 is given for each correct answer and a value of 0 is given for each incorrect answer. An overall knowledge score is calculated for each patient by dividing the number of correct responses (range 0-9) by 9 to be re-scaled from 0-100. Higher values indicate higher knowledge.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
396 participants
Primary outcome timeframe
After initial visit but before surgery, estimated to be before day 7
Results posted on
2024-08-12
Participant Flow
Participant milestones
| Measure |
BREASTChoice
* After consent, the participant will be randomized
* Depending on the clinic work-flow, the patient will be sent the link to the BREASTChoice tool by email or MyChart message
* 1\) prior to their visit with the surgeon;
* 2\) at the time of their visit with the surgeon;
* 3\) after the surgeon appointment
* Will receive an online survey to complete after viewing the BREASTChoice tool assessing socio-demographics, knowledge, health literacy, decisional conflict, patient engagement, health-related quality of life, preferred decision role, and usability of the website.
* Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
|
Attention Control Website
* After consent, the participant will be randomized
* Depending on the clinic work-flow, the patient will be sent the link to the website by email or MyChart message
* 1\) prior to their visit with the surgeon;
* 2\) at the time of their visit with the surgeon;
* 3\) after the surgeon appointment
* Will receive an online survey to complete after viewing the website assessing socio-demographics, knowledge, preferences, health literacy, decisional conflict, measure of patient engagement, health-related quality of life, preferred decision role, consult time, and usability of the website.
* Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
|
Clinicians
* Will receive a brief virtual training on how BREASTChoice functions and the features, including placement of the patient tool summary in the electronic health record
* Will complete pre-post trial survey about shared decision making
|
|---|---|---|---|
|
Overall Study
STARTED
|
187
|
186
|
23
|
|
Overall Study
COMPLETED
|
156
|
165
|
20
|
|
Overall Study
NOT COMPLETED
|
31
|
21
|
3
|
Reasons for withdrawal
| Measure |
BREASTChoice
* After consent, the participant will be randomized
* Depending on the clinic work-flow, the patient will be sent the link to the BREASTChoice tool by email or MyChart message
* 1\) prior to their visit with the surgeon;
* 2\) at the time of their visit with the surgeon;
* 3\) after the surgeon appointment
* Will receive an online survey to complete after viewing the BREASTChoice tool assessing socio-demographics, knowledge, health literacy, decisional conflict, patient engagement, health-related quality of life, preferred decision role, and usability of the website.
* Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
|
Attention Control Website
* After consent, the participant will be randomized
* Depending on the clinic work-flow, the patient will be sent the link to the website by email or MyChart message
* 1\) prior to their visit with the surgeon;
* 2\) at the time of their visit with the surgeon;
* 3\) after the surgeon appointment
* Will receive an online survey to complete after viewing the website assessing socio-demographics, knowledge, preferences, health literacy, decisional conflict, measure of patient engagement, health-related quality of life, preferred decision role, consult time, and usability of the website.
* Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
|
Clinicians
* Will receive a brief virtual training on how BREASTChoice functions and the features, including placement of the patient tool summary in the electronic health record
* Will complete pre-post trial survey about shared decision making
|
|---|---|---|---|
|
Overall Study
Accidently randomized
|
3
|
1
|
0
|
|
Overall Study
Did not complete survey
|
28
|
20
|
3
|
Baseline Characteristics
Age was not collected on Clinicians.
Baseline characteristics by cohort
| Measure |
BREASTChoice
n=184 Participants
* After consent, the participant will be randomized
* Depending on the clinic work-flow, the patient will be sent the link to the BREASTChoice tool by email or MyChart message
* 1\) prior to their visit with the surgeon;
* 2\) at the time of their visit with the surgeon;
* 3\) after the surgeon appointment
* Will receive an online survey to complete after viewing the BREASTChoice tool assessing socio-demographics, knowledge, health literacy, decisional conflict, patient engagement, health-related quality of life, preferred decision role, and usability of the website.
* Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
|
Attention Control Website
n=185 Participants
* After consent, the participant will be randomized
* Depending on the clinic work-flow, the patient will be sent the link to the website by email or MyChart message
* 1\) prior to their visit with the surgeon;
* 2\) at the time of their visit with the surgeon;
* 3\) after the surgeon appointment
* Will receive an online survey to complete after viewing the website assessing socio-demographics, knowledge, preferences, health literacy, decisional conflict, measure of patient engagement, health-related quality of life, preferred decision role, consult time, and usability of the website.
* Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
|
Clinicians
n=23 Participants
* Will receive a brief virtual training on how BREASTChoice functions and the features, including placement of the patient tool summary in the electronic health record
* Will complete pre-post trial survey about shared decision making
|
Total
n=392 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=184 Participants • Age was not collected on Clinicians.
|
0 Participants
n=185 Participants • Age was not collected on Clinicians.
|
0 Participants
Age was not collected on Clinicians.
|
0 Participants
n=369 Participants • Age was not collected on Clinicians.
|
|
Age, Categorical
Between 18 and 65 years
|
156 Participants
n=184 Participants • Age was not collected on Clinicians.
|
158 Participants
n=185 Participants • Age was not collected on Clinicians.
|
0 Participants
Age was not collected on Clinicians.
|
314 Participants
n=369 Participants • Age was not collected on Clinicians.
|
|
Age, Categorical
>=65 years
|
28 Participants
n=184 Participants • Age was not collected on Clinicians.
|
27 Participants
n=185 Participants • Age was not collected on Clinicians.
|
0 Participants
Age was not collected on Clinicians.
|
55 Participants
n=369 Participants • Age was not collected on Clinicians.
|
|
Age, Continuous
|
51.0 years
n=184 Participants • Age was not collected on Clinicians.
|
51.2 years
n=185 Participants • Age was not collected on Clinicians.
|
—
|
51.3 years
n=369 Participants • Age was not collected on Clinicians.
|
|
Sex: Female, Male
Female
|
184 Participants
n=184 Participants
|
185 Participants
n=185 Participants
|
12 Participants
n=23 Participants
|
381 Participants
n=392 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=184 Participants
|
0 Participants
n=185 Participants
|
11 Participants
n=23 Participants
|
11 Participants
n=392 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=184 Participants
|
5 Participants
n=185 Participants
|
0 Participants
n=23 Participants
|
7 Participants
n=392 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
182 Participants
n=184 Participants
|
180 Participants
n=185 Participants
|
23 Participants
n=23 Participants
|
385 Participants
n=392 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=184 Participants
|
0 Participants
n=185 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=392 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=184 Participants
|
0 Participants
n=185 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=392 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=184 Participants
|
3 Participants
n=185 Participants
|
4 Participants
n=23 Participants
|
9 Participants
n=392 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=184 Participants
|
0 Participants
n=185 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=392 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=184 Participants
|
21 Participants
n=185 Participants
|
0 Participants
n=23 Participants
|
32 Participants
n=392 Participants
|
|
Race (NIH/OMB)
White
|
167 Participants
n=184 Participants
|
156 Participants
n=185 Participants
|
19 Participants
n=23 Participants
|
342 Participants
n=392 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=184 Participants
|
3 Participants
n=185 Participants
|
0 Participants
n=23 Participants
|
7 Participants
n=392 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=184 Participants
|
2 Participants
n=185 Participants
|
0 Participants
n=23 Participants
|
2 Participants
n=392 Participants
|
|
Region of Enrollment
United States
|
184 participants
n=184 Participants
|
185 participants
n=185 Participants
|
23 participants
n=23 Participants
|
392 participants
n=392 Participants
|
|
Breast cancer stage
Stage 0
|
41 Participants
n=184 Participants • This data was not collected on Clinicians.
|
32 Participants
n=185 Participants • This data was not collected on Clinicians.
|
—
|
73 Participants
n=369 Participants • This data was not collected on Clinicians.
|
|
Breast cancer stage
Stage I
|
75 Participants
n=184 Participants • This data was not collected on Clinicians.
|
77 Participants
n=185 Participants • This data was not collected on Clinicians.
|
—
|
152 Participants
n=369 Participants • This data was not collected on Clinicians.
|
|
Breast cancer stage
Stage II
|
45 Participants
n=184 Participants • This data was not collected on Clinicians.
|
54 Participants
n=185 Participants • This data was not collected on Clinicians.
|
—
|
99 Participants
n=369 Participants • This data was not collected on Clinicians.
|
|
Breast cancer stage
Stage III
|
22 Participants
n=184 Participants • This data was not collected on Clinicians.
|
19 Participants
n=185 Participants • This data was not collected on Clinicians.
|
—
|
41 Participants
n=369 Participants • This data was not collected on Clinicians.
|
|
Breast cancer stage
Stage IV
|
1 Participants
n=184 Participants • This data was not collected on Clinicians.
|
3 Participants
n=185 Participants • This data was not collected on Clinicians.
|
—
|
4 Participants
n=369 Participants • This data was not collected on Clinicians.
|
|
Annual household income
<$30,000
|
12 Participants
n=152 Participants • This data was not collected on Clinicians.
|
17 Participants
n=158 Participants • This data was not collected on Clinicians.
|
—
|
29 Participants
n=310 Participants • This data was not collected on Clinicians.
|
|
Annual household income
$30,000 to $74,999
|
33 Participants
n=152 Participants • This data was not collected on Clinicians.
|
28 Participants
n=158 Participants • This data was not collected on Clinicians.
|
—
|
61 Participants
n=310 Participants • This data was not collected on Clinicians.
|
|
Annual household income
$75,000 or more
|
91 Participants
n=152 Participants • This data was not collected on Clinicians.
|
96 Participants
n=158 Participants • This data was not collected on Clinicians.
|
—
|
187 Participants
n=310 Participants • This data was not collected on Clinicians.
|
|
Annual household income
Prefer not to answer
|
16 Participants
n=152 Participants • This data was not collected on Clinicians.
|
17 Participants
n=158 Participants • This data was not collected on Clinicians.
|
—
|
33 Participants
n=310 Participants • This data was not collected on Clinicians.
|
|
Educational attainment
High school or less
|
15 Participants
n=184 Participants
|
16 Participants
n=185 Participants
|
0 Participants
n=23 Participants
|
31 Participants
n=392 Participants
|
|
Educational attainment
Technical training
|
5 Participants
n=184 Participants
|
5 Participants
n=185 Participants
|
0 Participants
n=23 Participants
|
10 Participants
n=392 Participants
|
|
Educational attainment
Some college
|
26 Participants
n=184 Participants
|
22 Participants
n=185 Participants
|
0 Participants
n=23 Participants
|
48 Participants
n=392 Participants
|
|
Educational attainment
College degree
|
47 Participants
n=184 Participants
|
58 Participants
n=185 Participants
|
0 Participants
n=23 Participants
|
105 Participants
n=392 Participants
|
|
Educational attainment
Graduate/professional degree
|
49 Participants
n=184 Participants
|
57 Participants
n=185 Participants
|
23 Participants
n=23 Participants
|
129 Participants
n=392 Participants
|
PRIMARY outcome
Timeframe: After initial visit but before surgery, estimated to be before day 7Population: Overall number of participants analyzed include those in the intent to treat analysis. Data for this outcome measure was not collected on Clinicians.
-The validated Breast Reconstruction Decision Quality Instrument (DQI) knowledge scale contains 9 items on key facts about reconstruction. A value of 1 is given for each correct answer and a value of 0 is given for each incorrect answer. An overall knowledge score is calculated for each patient by dividing the number of correct responses (range 0-9) by 9 to be re-scaled from 0-100. Higher values indicate higher knowledge.
Outcome measures
| Measure |
BREASTChoice
n=156 Participants
* After consent, the participant will be randomized
* Depending on the clinic work-flow, the patient will be sent the link to the BREASTChoice tool by email or MyChart message
* 1\) prior to their visit with the surgeon;
* 2\) at the time of their visit with the surgeon;
* 3\) after the surgeon appointment
* Will receive an online survey to complete after viewing the BREASTChoice tool assessing socio-demographics, knowledge, health literacy, decisional conflict, patient engagement, health-related quality of life, preferred decision role, and usability of the website.
* Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
|
Attention Control Website
n=165 Participants
* After consent, the participant will be randomized
* Depending on the clinic work-flow, the patient will be sent the link to the website by email or MyChart message
* 1\) prior to their visit with the surgeon;
* 2\) at the time of their visit with the surgeon;
* 3\) after the surgeon appointment
* Will receive an online survey to complete after viewing the website assessing socio-demographics, knowledge, preferences, health literacy, decisional conflict, measure of patient engagement, health-related quality of life, preferred decision role, consult time, and usability of the website.
* Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
|
Clinicians
* Will receive a brief virtual training on how BREASTChoice functions and the features, including placement of the patient tool summary in the electronic health record
* Will complete pre-post trial survey about shared decision making
|
|---|---|---|---|
|
Knowledge as Measured by Decision Quality Instrument
|
66.7 score on a scale
Interval 66.7 to 77.8
|
66.7 score on a scale
Interval 55.6 to 77.8
|
—
|
PRIMARY outcome
Timeframe: Preference assessed after initial visit, estimated to be day 7; actual treatment received collected from the EHRPopulation: Overall number of participants analyzed include those in the intent to treat analysis. Data for this outcome measure was not collected on Clinicians.
* Investigators will estimate the patient's preferred treatment (mastectomy alone vs. mastectomy with reconstruction), by inputting values (entered into BREASTChoice or control survey) into a statistical model to compute preferred treatment. The investigators will compare preferred treatments to actual treatment received, with concordance determined by agreement between preferred and actual treatment received. The investigators will consider "actual treatment received" to be delayed reconstruction, if she states an intention to have delayed reconstruction, as she might not have started this process during the study. * Reconstruction vs no reconstruction excluded includes those who did not have a mastectomy, unsure or no preference, or received lumpectomy. * Immediate vs delayed reconstruction excluded includes those with unsure preference or no preference. * Flap vs implant reconstruction excluded includes those unsure of final reconstruction type, unsure preference, or no preference.
Outcome measures
| Measure |
BREASTChoice
n=156 Participants
* After consent, the participant will be randomized
* Depending on the clinic work-flow, the patient will be sent the link to the BREASTChoice tool by email or MyChart message
* 1\) prior to their visit with the surgeon;
* 2\) at the time of their visit with the surgeon;
* 3\) after the surgeon appointment
* Will receive an online survey to complete after viewing the BREASTChoice tool assessing socio-demographics, knowledge, health literacy, decisional conflict, patient engagement, health-related quality of life, preferred decision role, and usability of the website.
* Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
|
Attention Control Website
n=165 Participants
* After consent, the participant will be randomized
* Depending on the clinic work-flow, the patient will be sent the link to the website by email or MyChart message
* 1\) prior to their visit with the surgeon;
* 2\) at the time of their visit with the surgeon;
* 3\) after the surgeon appointment
* Will receive an online survey to complete after viewing the website assessing socio-demographics, knowledge, preferences, health literacy, decisional conflict, measure of patient engagement, health-related quality of life, preferred decision role, consult time, and usability of the website.
* Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
|
Clinicians
* Will receive a brief virtual training on how BREASTChoice functions and the features, including placement of the patient tool summary in the electronic health record
* Will complete pre-post trial survey about shared decision making
|
|---|---|---|---|
|
Preference Concordance
Reconstruction versus No reconstruction · Treatment matches preference
|
83 Participants
|
113 Participants
|
—
|
|
Preference Concordance
Reconstruction versus No reconstruction · Treatment does not match preference
|
13 Participants
|
9 Participants
|
—
|
|
Preference Concordance
Reconstruction versus No reconstruction · Excluded
|
60 Participants
|
43 Participants
|
—
|
|
Preference Concordance
Immediate reconstruction versus delayed reconstruction · Treatment matches preference
|
48 Participants
|
73 Participants
|
—
|
|
Preference Concordance
Immediate reconstruction versus delayed reconstruction · Treatment does not match preference
|
11 Participants
|
22 Participants
|
—
|
|
Preference Concordance
Immediate reconstruction versus delayed reconstruction · Excluded
|
44 Participants
|
14 Participants
|
—
|
|
Preference Concordance
Flap reconstruction versus Implant reconstruction · Treatment matches preference
|
33 Participants
|
60 Participants
|
—
|
|
Preference Concordance
Flap reconstruction versus Implant reconstruction · Treatment does not match preference
|
6 Participants
|
16 Participants
|
—
|
|
Preference Concordance
Flap reconstruction versus Implant reconstruction · Excluded
|
64 Participants
|
33 Participants
|
—
|
PRIMARY outcome
Timeframe: After initial visit but before surgery, estimated to be before day 7Population: Overall number of participants analyzed include those in the intent to treat analysis. Data for this outcome measure was not collected on Clinicians.
-The validated, widely-used SURE (Sure of myself; Understand information; Risk-benefit ratio; Encouragement) Measure of Decisional Conflict asks whether patients have enough information to make a choice, enough support to make a choice, and are clear about their values. It is a 4-item measure of yes/no questions (1=yes, 0=no). A score of ≤3 indicates decisional conflict; the outcome is binary indicating a score of 4 (no decisional conflict) vs. ≤3 (presence of decisional conflict).
Outcome measures
| Measure |
BREASTChoice
n=142 Participants
* After consent, the participant will be randomized
* Depending on the clinic work-flow, the patient will be sent the link to the BREASTChoice tool by email or MyChart message
* 1\) prior to their visit with the surgeon;
* 2\) at the time of their visit with the surgeon;
* 3\) after the surgeon appointment
* Will receive an online survey to complete after viewing the BREASTChoice tool assessing socio-demographics, knowledge, health literacy, decisional conflict, patient engagement, health-related quality of life, preferred decision role, and usability of the website.
* Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
|
Attention Control Website
n=157 Participants
* After consent, the participant will be randomized
* Depending on the clinic work-flow, the patient will be sent the link to the website by email or MyChart message
* 1\) prior to their visit with the surgeon;
* 2\) at the time of their visit with the surgeon;
* 3\) after the surgeon appointment
* Will receive an online survey to complete after viewing the website assessing socio-demographics, knowledge, preferences, health literacy, decisional conflict, measure of patient engagement, health-related quality of life, preferred decision role, consult time, and usability of the website.
* Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
|
Clinicians
* Will receive a brief virtual training on how BREASTChoice functions and the features, including placement of the patient tool summary in the electronic health record
* Will complete pre-post trial survey about shared decision making
|
|---|---|---|---|
|
Decisional Conflict as Measured by the SURE (Sure of Myself; Understand Information; Risk-benefit Ratio; Encouragement) Scale for Decisional Conflict
Decisional conflict
|
31 Participants
|
44 Participants
|
—
|
|
Decisional Conflict as Measured by the SURE (Sure of Myself; Understand Information; Risk-benefit Ratio; Encouragement) Scale for Decisional Conflict
No decisional conflict
|
111 Participants
|
113 Participants
|
—
|
SECONDARY outcome
Timeframe: After patient participation (approximately 18 months)Population: Overall number of participants analyzed include those in the intent to treat analysis. Data for this outcome measure was not collected on Clinicians.
-Participants will be considered high-risk if their risk exceeds two times the population average
Outcome measures
| Measure |
BREASTChoice
n=16 Participants
* After consent, the participant will be randomized
* Depending on the clinic work-flow, the patient will be sent the link to the BREASTChoice tool by email or MyChart message
* 1\) prior to their visit with the surgeon;
* 2\) at the time of their visit with the surgeon;
* 3\) after the surgeon appointment
* Will receive an online survey to complete after viewing the BREASTChoice tool assessing socio-demographics, knowledge, health literacy, decisional conflict, patient engagement, health-related quality of life, preferred decision role, and usability of the website.
* Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
|
Attention Control Website
n=13 Participants
* After consent, the participant will be randomized
* Depending on the clinic work-flow, the patient will be sent the link to the website by email or MyChart message
* 1\) prior to their visit with the surgeon;
* 2\) at the time of their visit with the surgeon;
* 3\) after the surgeon appointment
* Will receive an online survey to complete after viewing the website assessing socio-demographics, knowledge, preferences, health literacy, decisional conflict, measure of patient engagement, health-related quality of life, preferred decision role, consult time, and usability of the website.
* Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
|
Clinicians
* Will receive a brief virtual training on how BREASTChoice functions and the features, including placement of the patient tool summary in the electronic health record
* Will complete pre-post trial survey about shared decision making
|
|---|---|---|---|
|
Compare Number of High-risk Participants From Each Arm Who Chose Breast Reconstruction
|
10 Participants
|
11 Participants
|
—
|
SECONDARY outcome
Timeframe: Assessed pre- and post-study (approximately 24 months)Population: This outcome measure is for Clinicians only.
-The Continuing Professional Development (CPD) Reaction scale is a 12-item measure with each item having a scale of 1-7. These 12 items correspond to the following 5 constructs (2-3 items per construct) are assessed: intention (2 items), social influence (3 items), beliefs about capabilities (3 items), moral norm (2 items), and beliefs about consequence (2 items). The possible scale range is 1-7. Higher values or a positive change indicates higher intention, social influence, beliefs about capabilities, moral norm, or beliefs about consequences of engaging in shared decision making. Each scale is reported as an average. \*\*For clinician arm only
Outcome measures
| Measure |
BREASTChoice
* After consent, the participant will be randomized
* Depending on the clinic work-flow, the patient will be sent the link to the BREASTChoice tool by email or MyChart message
* 1\) prior to their visit with the surgeon;
* 2\) at the time of their visit with the surgeon;
* 3\) after the surgeon appointment
* Will receive an online survey to complete after viewing the BREASTChoice tool assessing socio-demographics, knowledge, health literacy, decisional conflict, patient engagement, health-related quality of life, preferred decision role, and usability of the website.
* Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
|
Attention Control Website
* After consent, the participant will be randomized
* Depending on the clinic work-flow, the patient will be sent the link to the website by email or MyChart message
* 1\) prior to their visit with the surgeon;
* 2\) at the time of their visit with the surgeon;
* 3\) after the surgeon appointment
* Will receive an online survey to complete after viewing the website assessing socio-demographics, knowledge, preferences, health literacy, decisional conflict, measure of patient engagement, health-related quality of life, preferred decision role, consult time, and usability of the website.
* Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
|
Clinicians
n=20 Participants
* Will receive a brief virtual training on how BREASTChoice functions and the features, including placement of the patient tool summary in the electronic health record
* Will complete pre-post trial survey about shared decision making
|
|---|---|---|---|
|
Provider Intention to Engage in Shared Decision Making as Measured by the Change in the Mean CPD (Continuing Professional Development)-Reaction Scale
Intention (Pre-Study)
|
—
|
—
|
6.40 score on a scale
Standard Deviation 0.8
|
|
Provider Intention to Engage in Shared Decision Making as Measured by the Change in the Mean CPD (Continuing Professional Development)-Reaction Scale
Intention (Post-Study)
|
—
|
—
|
6.55 score on a scale
Standard Deviation 0.76
|
|
Provider Intention to Engage in Shared Decision Making as Measured by the Change in the Mean CPD (Continuing Professional Development)-Reaction Scale
Social influence (Pre-Study)
|
—
|
—
|
5.23 score on a scale
Standard Deviation 1.78
|
|
Provider Intention to Engage in Shared Decision Making as Measured by the Change in the Mean CPD (Continuing Professional Development)-Reaction Scale
Social influence (Post-Study)
|
—
|
—
|
5.18 score on a scale
Standard Deviation 1.57
|
|
Provider Intention to Engage in Shared Decision Making as Measured by the Change in the Mean CPD (Continuing Professional Development)-Reaction Scale
Beliefs about capabilities (Pre-Study)
|
—
|
—
|
6.04 score on a scale
Standard Deviation 0.86
|
|
Provider Intention to Engage in Shared Decision Making as Measured by the Change in the Mean CPD (Continuing Professional Development)-Reaction Scale
Beliefs about capabilities (Post-Study)
|
—
|
—
|
6.07 score on a scale
Standard Deviation 0.75
|
|
Provider Intention to Engage in Shared Decision Making as Measured by the Change in the Mean CPD (Continuing Professional Development)-Reaction Scale
Moral norm (Pre-Study)
|
—
|
—
|
6.43 score on a scale
Standard Deviation 0.75
|
|
Provider Intention to Engage in Shared Decision Making as Measured by the Change in the Mean CPD (Continuing Professional Development)-Reaction Scale
Moral norm (Post-Study)
|
—
|
—
|
6.68 score on a scale
Standard Deviation 0.56
|
|
Provider Intention to Engage in Shared Decision Making as Measured by the Change in the Mean CPD (Continuing Professional Development)-Reaction Scale
Beliefs about consequences (Pre-Study)
|
—
|
—
|
6.33 score on a scale
Standard Deviation 0.80
|
|
Provider Intention to Engage in Shared Decision Making as Measured by the Change in the Mean CPD (Continuing Professional Development)-Reaction Scale
Beliefs about consequences (Post-Study)
|
—
|
—
|
6.53 score on a scale
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: After initial visit but before surgery, estimated before day 7Population: Overall number of participants analyzed include those in the intent to treat analysis. Data for this outcome measure was not collected on Clinicians.
-This is a an 11-item measure using true/false/unsure response options. A knowledge score is calculated by dividing the number of correct responses (each scored 1 if correct, 0 if incorrect, unsure, or blank) by the number of knowledge items (11), to be re-scaled to 0-100. Higher values indicate higher knowledge.
Outcome measures
| Measure |
BREASTChoice
n=156 Participants
* After consent, the participant will be randomized
* Depending on the clinic work-flow, the patient will be sent the link to the BREASTChoice tool by email or MyChart message
* 1\) prior to their visit with the surgeon;
* 2\) at the time of their visit with the surgeon;
* 3\) after the surgeon appointment
* Will receive an online survey to complete after viewing the BREASTChoice tool assessing socio-demographics, knowledge, health literacy, decisional conflict, patient engagement, health-related quality of life, preferred decision role, and usability of the website.
* Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
|
Attention Control Website
n=165 Participants
* After consent, the participant will be randomized
* Depending on the clinic work-flow, the patient will be sent the link to the website by email or MyChart message
* 1\) prior to their visit with the surgeon;
* 2\) at the time of their visit with the surgeon;
* 3\) after the surgeon appointment
* Will receive an online survey to complete after viewing the website assessing socio-demographics, knowledge, preferences, health literacy, decisional conflict, measure of patient engagement, health-related quality of life, preferred decision role, consult time, and usability of the website.
* Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
|
Clinicians
* Will receive a brief virtual training on how BREASTChoice functions and the features, including placement of the patient tool summary in the electronic health record
* Will complete pre-post trial survey about shared decision making
|
|---|---|---|---|
|
Knowledge as Measured by Knowledge Questions Developed in Previous Studies
|
84.7 score on a scale
Standard Deviation 13.8
|
66.5 score on a scale
Standard Deviation 15.8
|
—
|
SECONDARY outcome
Timeframe: Initial visit (day 1)Population: The data for this outcome measure was not collected.
-Consult time using the BREASTChoice will be compared to consult using the attention control.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: After initial visit but before surgery, estimated to be before day 7Population: Only participants in the BREASTChoice arm were evaluable for this outcome measure.
-The System Usability Index (SUS) is a 10-item measure (each scaled 1-5) of how easy a website is to use. It is asked of only those in the BreastChoice group to assess the usability of tool. A usability score is calculated by adding the items and multiplying the sum by 2.5. Usability scores can range from 0-100 with higher scores indicating greater usability. A score greater than 68 indicates adequate usability.
Outcome measures
| Measure |
BREASTChoice
n=156 Participants
* After consent, the participant will be randomized
* Depending on the clinic work-flow, the patient will be sent the link to the BREASTChoice tool by email or MyChart message
* 1\) prior to their visit with the surgeon;
* 2\) at the time of their visit with the surgeon;
* 3\) after the surgeon appointment
* Will receive an online survey to complete after viewing the BREASTChoice tool assessing socio-demographics, knowledge, health literacy, decisional conflict, patient engagement, health-related quality of life, preferred decision role, and usability of the website.
* Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
|
Attention Control Website
* After consent, the participant will be randomized
* Depending on the clinic work-flow, the patient will be sent the link to the website by email or MyChart message
* 1\) prior to their visit with the surgeon;
* 2\) at the time of their visit with the surgeon;
* 3\) after the surgeon appointment
* Will receive an online survey to complete after viewing the website assessing socio-demographics, knowledge, preferences, health literacy, decisional conflict, measure of patient engagement, health-related quality of life, preferred decision role, consult time, and usability of the website.
* Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
|
Clinicians
* Will receive a brief virtual training on how BREASTChoice functions and the features, including placement of the patient tool summary in the electronic health record
* Will complete pre-post trial survey about shared decision making
|
|---|---|---|---|
|
Usability as Measured by the System Usability Scale (SUS)
|
84.6 score on a scale
Standard Deviation 14.3
|
—
|
—
|
SECONDARY outcome
Timeframe: After initial visit but before surgery, estimated to be before day 7Population: For this analysis, BREASTChoice participants who never accessed the tool were excluded. Data for this outcome measure was not collected on Clinicians.
-The validated Breast Reconstruction Decision Quality Instrument (DQI) knowledge scale contains 9 items on key facts about reconstruction. A knowledge score will be calculated for each patient by dividing the number of correct responses by the number of knowledge items. Value of 1 given for each correct answer and value of 0 for each incorrect answer. Overall knowledge score range is 0-9 re-scaled from 0-100.
Outcome measures
| Measure |
BREASTChoice
n=150 Participants
* After consent, the participant will be randomized
* Depending on the clinic work-flow, the patient will be sent the link to the BREASTChoice tool by email or MyChart message
* 1\) prior to their visit with the surgeon;
* 2\) at the time of their visit with the surgeon;
* 3\) after the surgeon appointment
* Will receive an online survey to complete after viewing the BREASTChoice tool assessing socio-demographics, knowledge, health literacy, decisional conflict, patient engagement, health-related quality of life, preferred decision role, and usability of the website.
* Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
|
Attention Control Website
n=165 Participants
* After consent, the participant will be randomized
* Depending on the clinic work-flow, the patient will be sent the link to the website by email or MyChart message
* 1\) prior to their visit with the surgeon;
* 2\) at the time of their visit with the surgeon;
* 3\) after the surgeon appointment
* Will receive an online survey to complete after viewing the website assessing socio-demographics, knowledge, preferences, health literacy, decisional conflict, measure of patient engagement, health-related quality of life, preferred decision role, consult time, and usability of the website.
* Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
|
Clinicians
* Will receive a brief virtual training on how BREASTChoice functions and the features, including placement of the patient tool summary in the electronic health record
* Will complete pre-post trial survey about shared decision making
|
|---|---|---|---|
|
Knowledge as Measured by Decision Quality Instrument
|
66.7 score on a scale
Interval 66.7 to 77.8
|
66.7 score on a scale
Interval 55.6 to 77.8
|
—
|
SECONDARY outcome
Timeframe: Preference assessed after initial visit, estimated to be day 7; actual treatment received collected from the EHRPopulation: For this analysis, BREASTChoice participants who never accessed the tool were excluded. Data for this outcome measure was not collected on Clinicians.
* The investigators will estimate the patient's preferred treatment (mastectomy alone versus mastectomy with reconstruction), by inputting values (entered into BREASTChoice or control survey) into a statistical model to compute preferred treatment. The investigators will compare preferred treatments to actual treatment received, with concordance determined by agreement between preferred and actual treatment received. The investigators will consider "actual treatment received" to be delayed reconstruction, if she states an intention to have delayed reconstruction, as she might not have started this process during the study. * Reconstruction vs no reconstruction excluded includes those who did not have a mastectomy, no preference, or received lumpectomy. * Immediate vs delayed reconstruction excluded includes those with unsure preference or no preference. * Flap vs implant reconstruction excluded includes those unsure of final reconstruction type, unsure preference, or no preference.
Outcome measures
| Measure |
BREASTChoice
n=150 Participants
* After consent, the participant will be randomized
* Depending on the clinic work-flow, the patient will be sent the link to the BREASTChoice tool by email or MyChart message
* 1\) prior to their visit with the surgeon;
* 2\) at the time of their visit with the surgeon;
* 3\) after the surgeon appointment
* Will receive an online survey to complete after viewing the BREASTChoice tool assessing socio-demographics, knowledge, health literacy, decisional conflict, patient engagement, health-related quality of life, preferred decision role, and usability of the website.
* Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
|
Attention Control Website
n=165 Participants
* After consent, the participant will be randomized
* Depending on the clinic work-flow, the patient will be sent the link to the website by email or MyChart message
* 1\) prior to their visit with the surgeon;
* 2\) at the time of their visit with the surgeon;
* 3\) after the surgeon appointment
* Will receive an online survey to complete after viewing the website assessing socio-demographics, knowledge, preferences, health literacy, decisional conflict, measure of patient engagement, health-related quality of life, preferred decision role, consult time, and usability of the website.
* Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
|
Clinicians
* Will receive a brief virtual training on how BREASTChoice functions and the features, including placement of the patient tool summary in the electronic health record
* Will complete pre-post trial survey about shared decision making
|
|---|---|---|---|
|
Preference Concordance as Measured by the Decision Quality Instrument
Reconstruction versus No reconstruction · Treatment matches preference
|
83 Participants
|
113 Participants
|
—
|
|
Preference Concordance as Measured by the Decision Quality Instrument
Reconstruction versus No reconstruction · Treatment does not match preference
|
13 Participants
|
9 Participants
|
—
|
|
Preference Concordance as Measured by the Decision Quality Instrument
Reconstruction versus No reconstruction · Excluded
|
54 Participants
|
43 Participants
|
—
|
|
Preference Concordance as Measured by the Decision Quality Instrument
Immediate reconstruction versus delayed reconstruction · Treatment matches preference
|
48 Participants
|
73 Participants
|
—
|
|
Preference Concordance as Measured by the Decision Quality Instrument
Immediate reconstruction versus delayed reconstruction · Treatment does not match preference
|
11 Participants
|
22 Participants
|
—
|
|
Preference Concordance as Measured by the Decision Quality Instrument
Immediate reconstruction versus delayed reconstruction · Excluded
|
41 Participants
|
14 Participants
|
—
|
|
Preference Concordance as Measured by the Decision Quality Instrument
Flap reconstruction versus Implant reconstruction · Treatment matches preference
|
33 Participants
|
60 Participants
|
—
|
|
Preference Concordance as Measured by the Decision Quality Instrument
Flap reconstruction versus Implant reconstruction · Treatment does not match preference
|
6 Participants
|
16 Participants
|
—
|
|
Preference Concordance as Measured by the Decision Quality Instrument
Flap reconstruction versus Implant reconstruction · Excluded
|
61 Participants
|
33 Participants
|
—
|
SECONDARY outcome
Timeframe: After initial visit but before surgery, estimated to be before day 7Population: For this analysis, BREASTChoice participants who never accessed the tool were excluded. If participants did not answer the questions, they were also excluded. Data for this outcome measure was not collected on Clinicians.
-The validated, widely-used SURE measure of decisional conflict asks whether patients have enough information to make a choice, enough support to make a choice, and are clear about their values. It is a 4-item measure of yes/no questions (1=yes, 0=no). A score of ≤3 indicates decisional conflict.
Outcome measures
| Measure |
BREASTChoice
n=136 Participants
* After consent, the participant will be randomized
* Depending on the clinic work-flow, the patient will be sent the link to the BREASTChoice tool by email or MyChart message
* 1\) prior to their visit with the surgeon;
* 2\) at the time of their visit with the surgeon;
* 3\) after the surgeon appointment
* Will receive an online survey to complete after viewing the BREASTChoice tool assessing socio-demographics, knowledge, health literacy, decisional conflict, patient engagement, health-related quality of life, preferred decision role, and usability of the website.
* Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
|
Attention Control Website
n=157 Participants
* After consent, the participant will be randomized
* Depending on the clinic work-flow, the patient will be sent the link to the website by email or MyChart message
* 1\) prior to their visit with the surgeon;
* 2\) at the time of their visit with the surgeon;
* 3\) after the surgeon appointment
* Will receive an online survey to complete after viewing the website assessing socio-demographics, knowledge, preferences, health literacy, decisional conflict, measure of patient engagement, health-related quality of life, preferred decision role, consult time, and usability of the website.
* Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
|
Clinicians
* Will receive a brief virtual training on how BREASTChoice functions and the features, including placement of the patient tool summary in the electronic health record
* Will complete pre-post trial survey about shared decision making
|
|---|---|---|---|
|
Decisional Conflict as Measured by the SURE (Sure of Myself; Understand Information; Risk-benefit Ratio; Encouragement) Scale for Decisional Conflict
Decisional conflict
|
31 Participants
|
44 Participants
|
—
|
|
Decisional Conflict as Measured by the SURE (Sure of Myself; Understand Information; Risk-benefit Ratio; Encouragement) Scale for Decisional Conflict
No decisional conflict
|
105 Participants
|
113 Participants
|
—
|
SECONDARY outcome
Timeframe: After patient participation (approximately 18 months)Population: Only high risk participants are included in this outcome measure. Data for this outcome measure was not collected on Clinicians.
-Participants will be considered high-risk if their risk exceeds two times the population average
Outcome measures
| Measure |
BREASTChoice
n=13 Participants
* After consent, the participant will be randomized
* Depending on the clinic work-flow, the patient will be sent the link to the BREASTChoice tool by email or MyChart message
* 1\) prior to their visit with the surgeon;
* 2\) at the time of their visit with the surgeon;
* 3\) after the surgeon appointment
* Will receive an online survey to complete after viewing the BREASTChoice tool assessing socio-demographics, knowledge, health literacy, decisional conflict, patient engagement, health-related quality of life, preferred decision role, and usability of the website.
* Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
|
Attention Control Website
n=13 Participants
* After consent, the participant will be randomized
* Depending on the clinic work-flow, the patient will be sent the link to the website by email or MyChart message
* 1\) prior to their visit with the surgeon;
* 2\) at the time of their visit with the surgeon;
* 3\) after the surgeon appointment
* Will receive an online survey to complete after viewing the website assessing socio-demographics, knowledge, preferences, health literacy, decisional conflict, measure of patient engagement, health-related quality of life, preferred decision role, consult time, and usability of the website.
* Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
|
Clinicians
* Will receive a brief virtual training on how BREASTChoice functions and the features, including placement of the patient tool summary in the electronic health record
* Will complete pre-post trial survey about shared decision making
|
|---|---|---|---|
|
Compare Number of High-risk Participants From Each Arm Who Chose Breast Reconstruction
|
8 Participants
|
11 Participants
|
—
|
Adverse Events
BREASTChoice
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention Control Website
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Clinicians
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mary Politi, Ph.D.
Washington University School of Medicine
Phone: 314-747-1967
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place