Trial Outcomes & Findings for Increasing Patients' Engagement in Breast Cancer Surgery Decision-Making (NCT NCT03766009)
NCT ID: NCT03766009
Last Updated: 2025-01-28
Results Overview
Power is defined as patients' self-perceived capacity to influence the decision-making encounter. This construct is measured using the Patient's Self-Efficacy in Patient-Physician Interactions (PEPPI)-5 point scale; the primary outcome measure is a total score ranging from 5-25, where higher scores indicate increased self-efficacy. The patient completes the PEPPI-5 questionnaire within 3 weeks post-surgical consultation.
ACTIVE_NOT_RECRUITING
NA
627 participants
3 weeks
2025-01-28
Participant Flow
A total of 627 participants were enrolled. Five-hundred and ninety-eight patients (265 UC, 333 DA) were enrolled between June 2019 to December 2021 with 576 (265 UC, 311 DA) during stepped wedge design and 22 extended enrollment beyond Wave 7 (all DA). Twenty-nine surgeons were enrolled between April 2019 to October 2021 with the majority enrolled at the start of the study, while a few additional surgeons were enrolled as they joined the clinic.
This stepped wedge cluster randomized trial across 10 sites transitioned sites from UC to DA at pre-determined and randomly assigned timepoints, with waves spanning 10-13 weeks each. Sites started in UC and ended with DA. One wave is used for implementation of the DA at the time of crossover, yielding 6 waves for enrollment/data collection. The extended enrollment was to enrich the sample for the mixed methods components of the analysis. Surgeon enrollment was not linked to specific wave.
Unit of analysis: Sites
Participant milestones
| Measure |
Site 1 and 2
10-13 weeks Usual Care (Participants receive care as per usual care), 10 weeks Implementation (Decision aid implemented at the corresponding clinic) and 65-82 weeks Intervention (Participants receive a web-based decision aid intervention prior to the surgical consultation)
|
Sites 3 and 4
20-26 weeks Usual Care (Participants receive care as per usual care), 10 weeks Implementation (Decision aid implemented at the corresponding clinic), 46-70 weeks Intervention (Participants receive a web-based decision aid intervention prior to the surgical consultation) and 14 Weeks Extended Enrollment Beyond Wave 7 (Participants receive a web-based decision aid intervention prior to the surgical consultation. The extended enrollment was to enrich the sample for the mixed methods components of the analysis.)
|
Sites 5 and 6
56-68 weeks Usual Care (Participants receive care as per usual care), 10 weeks Implementation (Decision aid implemented at the corresponding clinic), 36-39 weeks Intervention (Participants receive a web-based decision aid intervention prior to the surgical consultation) and 1-10 Weeks Extended Enrollment Beyond Wave 7 (Participants receive a web-based decision aid intervention prior to the surgical consultation. The extended enrollment was to enrich the sample for the mixed methods components of the analysis.)
|
Sites 7 and 8
70-71 weeks Usual Care (Participants receive care as per usual care), 10 weeks Implementation (Decision aid implemented at the corresponding clinic), 23-26 weeks Intervention (Participants receive a web-based decision aid intervention prior to the surgical consultation) and 12-15 Weeks Extended Enrollment Beyond Wave 7 (Participants receive a web-based decision aid intervention prior to the surgical consultation. The extended enrollment was to enrich the sample for the mixed methods components of the analysis.)
|
Sites 9 and 10
75-80 weeks Usual Care (Participants receive care as per usual care), 10 weeks Implementation (Decision aid implemented at the corresponding clinic), 10-13 weeks Intervention (Participants receive a web-based decision aid intervention prior to the surgical consultation) and 18 Weeks Extended Enrollment Beyond Wave 7 (Participants receive a web-based decision aid intervention prior to the surgical consultation. The extended enrollment was to enrich the sample for the mixed methods components of the analysis.)
|
Surgeons
Surgeons accrual across sites
|
|---|---|---|---|---|---|---|
|
Usual Care
STARTED
|
26 2
|
54 2
|
34 2
|
74 2
|
77 2
|
28 10
|
|
Usual Care
COMPLETED
|
26 2
|
51 2
|
32 2
|
68 2
|
76 2
|
26 10
|
|
Usual Care
NOT COMPLETED
|
0 0
|
3 0
|
2 0
|
6 0
|
1 0
|
2 0
|
|
Implementation
STARTED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
26 10
|
|
Implementation
COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
26 10
|
|
Implementation
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Intervention
STARTED
|
124 2
|
109 2
|
32 2
|
32 2
|
14 2
|
27 10
|
|
Intervention
COMPLETED
|
118 2
|
101 2
|
31 2
|
25 2
|
14 2
|
27 10
|
|
Intervention
NOT COMPLETED
|
6 0
|
8 0
|
1 0
|
7 0
|
0 0
|
0 0
|
|
Extended Enrollment Beyond Wave 7
STARTED
|
0 0
|
16 2
|
0 0
|
0 0
|
6 2
|
18 10
|
|
Extended Enrollment Beyond Wave 7
COMPLETED
|
0 0
|
12 2
|
0 0
|
0 0
|
6 2
|
18 10
|
|
Extended Enrollment Beyond Wave 7
NOT COMPLETED
|
0 0
|
4 0
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
| Measure |
Site 1 and 2
10-13 weeks Usual Care (Participants receive care as per usual care), 10 weeks Implementation (Decision aid implemented at the corresponding clinic) and 65-82 weeks Intervention (Participants receive a web-based decision aid intervention prior to the surgical consultation)
|
Sites 3 and 4
20-26 weeks Usual Care (Participants receive care as per usual care), 10 weeks Implementation (Decision aid implemented at the corresponding clinic), 46-70 weeks Intervention (Participants receive a web-based decision aid intervention prior to the surgical consultation) and 14 Weeks Extended Enrollment Beyond Wave 7 (Participants receive a web-based decision aid intervention prior to the surgical consultation. The extended enrollment was to enrich the sample for the mixed methods components of the analysis.)
|
Sites 5 and 6
56-68 weeks Usual Care (Participants receive care as per usual care), 10 weeks Implementation (Decision aid implemented at the corresponding clinic), 36-39 weeks Intervention (Participants receive a web-based decision aid intervention prior to the surgical consultation) and 1-10 Weeks Extended Enrollment Beyond Wave 7 (Participants receive a web-based decision aid intervention prior to the surgical consultation. The extended enrollment was to enrich the sample for the mixed methods components of the analysis.)
|
Sites 7 and 8
70-71 weeks Usual Care (Participants receive care as per usual care), 10 weeks Implementation (Decision aid implemented at the corresponding clinic), 23-26 weeks Intervention (Participants receive a web-based decision aid intervention prior to the surgical consultation) and 12-15 Weeks Extended Enrollment Beyond Wave 7 (Participants receive a web-based decision aid intervention prior to the surgical consultation. The extended enrollment was to enrich the sample for the mixed methods components of the analysis.)
|
Sites 9 and 10
75-80 weeks Usual Care (Participants receive care as per usual care), 10 weeks Implementation (Decision aid implemented at the corresponding clinic), 10-13 weeks Intervention (Participants receive a web-based decision aid intervention prior to the surgical consultation) and 18 Weeks Extended Enrollment Beyond Wave 7 (Participants receive a web-based decision aid intervention prior to the surgical consultation. The extended enrollment was to enrich the sample for the mixed methods components of the analysis.)
|
Surgeons
Surgeons accrual across sites
|
|---|---|---|---|---|---|---|
|
Usual Care
Death
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Usual Care
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Usual Care
Treatment goals changed due to metastatic disease
|
0
|
0
|
2
|
0
|
1
|
0
|
|
Usual Care
Transferred care/moved out of state, limited information on chart review
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Usual Care
No treatment or declined surgery
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Usual Care
No surgery but had lymph node dissection instead
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Usual Care
No surgery since patient had a good response to endocrine therapy
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Usual Care
Ineligible
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Usual Care
Other: Staff turnover
|
0
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Age not collected on surgeons
Baseline characteristics by cohort
| Measure |
UC (Usual Care)
n=264 Participants
Participants receive care as per usual care. Participant assignment to usual care or decision aid intervention was determined by the phase the site was in at time of participant enrollment.
|
DA (Decision Aid Intervention)
n=309 Participants
Participants receive a web-based decision aid intervention prior to the surgical consultation. Participant assignment to usual care or decision aid intervention was determined by the phase the site was in at time of participant enrollment.
|
Extended Enrollment Beyond Wave 7-DA (Decision Aid Intervention)
n=22 Participants
Participants receive a web-based decision aid intervention prior to the surgical consultation. The extended enrollment was to enrich the sample for the mixed methods components of the analysis.
|
Surgeons
n=29 Participants
Participants consent for participation in site implementation activities, allowing their patients to receive the decision aid, a baseline survey, and audio-recording of their patient consultations.
|
Total
n=624 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59 years
n=264 Participants • Age not collected on surgeons
|
61 years
n=309 Participants • Age not collected on surgeons
|
63.5 years
n=22 Participants • Age not collected on surgeons
|
—
|
61 years
n=595 Participants • Age not collected on surgeons
|
|
Sex: Female, Male
Female
|
264 Participants
n=264 Participants • Sex not collected on surgeons
|
309 Participants
n=309 Participants • Sex not collected on surgeons
|
22 Participants
n=22 Participants • Sex not collected on surgeons
|
—
|
595 Participants
n=595 Participants • Sex not collected on surgeons
|
|
Sex: Female, Male
Male
|
0 Participants
n=264 Participants • Sex not collected on surgeons
|
0 Participants
n=309 Participants • Sex not collected on surgeons
|
0 Participants
n=22 Participants • Sex not collected on surgeons
|
—
|
0 Participants
n=595 Participants • Sex not collected on surgeons
|
|
Race/Ethnicity, Customized
Race · White
|
169 Participants
n=264 Participants
|
207 Participants
n=309 Participants
|
16 Participants
n=22 Participants
|
18 Participants
n=29 Participants
|
410 Participants
n=624 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
60 Participants
n=264 Participants
|
62 Participants
n=309 Participants
|
6 Participants
n=22 Participants
|
0 Participants
n=29 Participants
|
128 Participants
n=624 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
35 Participants
n=264 Participants
|
40 Participants
n=309 Participants
|
0 Participants
n=22 Participants
|
11 Participants
n=29 Participants
|
86 Participants
n=624 Participants
|
|
Socioeconomic Disadvantage
Yes
|
73 Participants
n=264 Participants • Socioeconomic disadvantage was not collected on surgeons
|
59 Participants
n=309 Participants • Socioeconomic disadvantage was not collected on surgeons
|
6 Participants
n=22 Participants • Socioeconomic disadvantage was not collected on surgeons
|
—
|
138 Participants
n=595 Participants • Socioeconomic disadvantage was not collected on surgeons
|
|
Socioeconomic Disadvantage
No
|
191 Participants
n=264 Participants • Socioeconomic disadvantage was not collected on surgeons
|
250 Participants
n=309 Participants • Socioeconomic disadvantage was not collected on surgeons
|
16 Participants
n=22 Participants • Socioeconomic disadvantage was not collected on surgeons
|
—
|
457 Participants
n=595 Participants • Socioeconomic disadvantage was not collected on surgeons
|
PRIMARY outcome
Timeframe: 3 weeksPopulation: All stepped wedge design participants who had PEPPI-5 data available excluding 5 UC (1 ineligible, 4 enrolled off-schedule) and 3 DA (2 refused follow-up at baseline, 1 enrolled off-schedule).
Power is defined as patients' self-perceived capacity to influence the decision-making encounter. This construct is measured using the Patient's Self-Efficacy in Patient-Physician Interactions (PEPPI)-5 point scale; the primary outcome measure is a total score ranging from 5-25, where higher scores indicate increased self-efficacy. The patient completes the PEPPI-5 questionnaire within 3 weeks post-surgical consultation.
Outcome measures
| Measure |
UC (Usual Care)
n=238 Participants
Participants receive care as per usual care. Participant assignment to usual care or decision aid intervention was determined by the phase the site was in at time of participant enrollment.
|
DA (Decision Aid Intervention)
n=268 Participants
Participants receive a web-based decision aid intervention prior to the surgical consultation. Participant assignment to usual care or decision aid intervention was determined by the phase the site was in at time of participant enrollment.
|
|---|---|---|
|
Patient Power: Self-efficacy in Patient Physician Interactions
|
22 score on a scale
Interval 7.0 to 25.0
|
22 score on a scale
Interval 5.0 to 25.0
|
PRIMARY outcome
Timeframe: 1 dayPopulation: All stepped wedge design participants who had active patient participation behaviors data available excluding 5 UC (1 ineligible and 4 enrolled off-schedule) and 3 DA (2 refused follow-up at baseline and 1 enrolled off-schedule).
Power is also separately measured by the validated Active Patient Participation Behaviors System to assess active patient participation during the surgeon consultation and is measured off the audio-recording of the consultation; a summary measure of patient's active involvement in the interaction is coded by the study team and represents a total count of patients' communicative behaviors (i.e., count of patient asking questions, count of patient assertive responses and count of patient expressions of concern) ranging from 0-114, where higher scores indicate increased active patient participation. The consultation for a patient will typically be study day 1 (day of registration).
Outcome measures
| Measure |
UC (Usual Care)
n=258 Participants
Participants receive care as per usual care. Participant assignment to usual care or decision aid intervention was determined by the phase the site was in at time of participant enrollment.
|
DA (Decision Aid Intervention)
n=301 Participants
Participants receive a web-based decision aid intervention prior to the surgical consultation. Participant assignment to usual care or decision aid intervention was determined by the phase the site was in at time of participant enrollment.
|
|---|---|---|
|
Patient Power: Active Patient Participation
|
17.5 count of patient communicative behaviors
Interval 0.0 to 114.0
|
19 count of patient communicative behaviors
Interval 0.0 to 112.0
|
SECONDARY outcome
Timeframe: Up to 3 weeksPatient knowledge is measured from 5 knowledge questions in the Decision Quality Instrument-Breast Surgery survey, with a percent correct recorded as the secondary outcome measure, ranging from 0-100%. The patient completes the Decision Quality Instrument-Breast Surgery survey within 3 weeks post-surgical consultation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 weeksThis is a binary outcome reflecting whether surgery received (mastectomy; lumpectomy) was concordant or not with the patient's personal values. The patient's personal values are measured from 3 questions on the Decision Quality Instrument (DQI)-Breast Surgery survey; each question ranges from 0 (not at all important) to 10 (extremely important). . The patient completes the DQI within 3 weeks post-consultation. The method by Sepucha et al (2012) will be applied to determine concordance between personal values and surgery received.
Outcome measures
Outcome data not reported
Adverse Events
UC (Usual Care)
DA (Decision Aid Intervention)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Heather B. Neuman, MD, MS
University of Wisconsin School of Medicine and Public Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place