Increasing Patients' Engagement in Breast Cancer Surgery Decision-Making
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|ClinicalTrials.gov Identifier: NCT03766009|
Recruitment Status : Suspended (COVID-19)
First Posted : December 5, 2018
Last Update Posted : April 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Stage 0 Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage III||Other: Usual Care Other: Web-based decision aid||Not Applicable|
The primary and secondary objectives of the study:
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1050 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Institutional cross-over|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Increasing Socioeconomically Disadvantaged Patients' Engagement in Breast Cancer Surgery Decision Making Through a Shared Decision Making Intervention|
|Actual Study Start Date :||March 1, 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2022|
Active Comparator: Arm I (surgical consultation)
Prior to institutional crossover, participants receive care as per usual care.
Other: Usual Care
Experimental: Arm II (web-based breast cancer surgery decision aid)
Following a 10 week implementation period, at the time of institutional crossover, participants will receive a web-based decision aid prior to the surgical consultation..
Other: Usual Care
Other: Web-based decision aid
Web-based decision aid received prior to the surgical consultation
- Patient power: self-efficacy in patient physician interactions [ Time Frame: Up to 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 [ Time Frame: 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 a third party and represents a count of patients' communicative behaviors ranging from 0-99, where higher scores indicate increased active patient participation. The consultation for a patient will typically be study day 1 (day of registration).
- Patient knowledge [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766009
|Study Chair:||Heather B. Neuman,, MD, MS||University of Wisconsin, Madison|