Breast Cancer Stage 0, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III
Conditions
Brief summary
This trial studies how well a breast cancer surgery decision aid works in increasing patient engagement in decision making for patients with newly diagnosed stage 0-III breast cancer. The trial also examines barriers to patient engagement even with the use of a decision aid, and if barriers are more likely to be experienced by socioeconomically disadvantaged patients.
Detailed description
The primary and secondary objectives of the study: PRIMARY OBJECTIVES: I. Test the effectiveness of a breast cancer surgery decision aid in increasing patient engagement in decision making (measured by knowledge and power) in clinics serving a high proportion of socioeconomically disadvantaged patients. II. Test the extent to which the effect of a decision aid on patient engagement is mediated through the mitigation of barriers and determine if persistent barriers are disproportionately experienced by socioeconomically disadvantaged patients. SECONDARY OBJECTIVES: I. Characterize how persistent barriers influence patient engagement in decision making in order to identify targets for adjunct interventions that could be implemented in clinics serving a high proportion of socioeconomically disadvantaged patients. Trial Design: OUTLINE: This is a multi-site cluster randomized trial using a stepped wedge design. Ten clinics will be recruited for participation. All clinics will begin in the usual care arm. Clinics will be randomized to the timing with which they cross-over to the decision aid intervention, with new clinics crossing over every 10 weeks. ARM I: usual care ARM II: decision aid intervention The only difference between patients enrolled before institutional crossover and patients enrolled after institutional crossover is those who are enrolled after institutional crossover will have been offered the decision aid as accepted practice in the clinic.
Interventions
OTHERUsual Care
Usual Care
Web-based decision aid received prior to the surgical consultation
Sponsors
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Agency for Healthcare Research and Quality (AHRQ)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Institutional cross-over
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed with stage 0-III breast cancer * Eligible patients must be planning breast surgery as a component of their definitive treatment * Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study * Patients with hearing impairment requiring the use of an interpreter are not eligible for this study * Patients must be able to speak English with the fluency required to have a direct discussion around treatment decision-making (i.e. without interpreter) * CLINIC STAKEHOLDER (SURGEONS AND CLINIC STAFF): Breast surgeon(s) and nursing staff, medical assistant, or mid-level provider at each participating clinic who participates in the care of patients newly diagnosed with breast cancer * INSTITUTIONAL: 10 clinics that annually provide surgical care for 120-300 patients newly diagnosed with breast cancer will be selected to participate in this study * INSTITUTIONAL: Surgeons at eligible clinics must consent to the study as a requirement for site participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Power: Self-efficacy in Patient Physician Interactions | 3 weeks | 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. |
| Patient Power: Active Patient Participation | 1 day | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Knowledge | Up to 3 weeks | Patient 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. |
| Concordance Between Personal Values and Surgery Received | Up to 3 weeks | This 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. |
Countries
Guam, Puerto Rico, United States
Contacts
STUDY_CHAIRHeather B. Neuman,, MD, MS
University of Wisconsin, Madison
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| UC (Usual Care) 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. | 264 |
| DA (Decision Aid Intervention) 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. | 309 |
| Extended Enrollment Beyond Wave 7-DA (Decision Aid Intervention) 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. | 22 |
| Surgeons 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. | 29 |
| Total | 624 |
Baseline characteristics
| Characteristic | UC (Usual Care) | DA (Decision Aid Intervention) | Extended Enrollment Beyond Wave 7-DA (Decision Aid Intervention) | Total | Surgeons |
|---|---|---|---|---|---|
| Age, Continuous | 59 years | 61 years | 63.5 years | 61 years | — |
| Race/Ethnicity, Customized Race Black | 60 Participants | 62 Participants | 6 Participants | 128 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Other | 35 Participants | 40 Participants | 0 Participants | 86 Participants | 11 Participants |
| Race/Ethnicity, Customized Race White | 169 Participants | 207 Participants | 16 Participants | 410 Participants | 18 Participants |
| Sex: Female, Male Female | 264 Participants | 309 Participants | 22 Participants | 595 Participants | — |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — |
| Socioeconomic Disadvantage No | 191 Participants | 250 Participants | 16 Participants | 457 Participants | — |
| Socioeconomic Disadvantage Yes | 73 Participants | 59 Participants | 6 Participants | 138 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 264 | 1 / 309 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Patient Power: Active Patient Participation
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).
Time frame: 1 day
Population: 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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| UC (Usual Care) | Patient Power: Active Patient Participation | 17.5 count of patient communicative behaviors |
| DA (Decision Aid Intervention) | Patient Power: Active Patient Participation | 19 count of patient communicative behaviors |
Primary
Patient Power: Self-efficacy in Patient Physician Interactions
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.
Time frame: 3 weeks
Population: 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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| UC (Usual Care) | Patient Power: Self-efficacy in Patient Physician Interactions | 22 score on a scale |
| DA (Decision Aid Intervention) | Patient Power: Self-efficacy in Patient Physician Interactions | 22 score on a scale |
Secondary
Concordance Between Personal Values and Surgery Received
This 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.
Time frame: Up to 3 weeks
Secondary
Patient Knowledge
Patient 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.
Time frame: Up to 3 weeks