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Increasing Patients' Engagement in Breast Cancer Surgery Decision-Making

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ClinicalTrials.gov Identifier: NCT03766009
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : May 16, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date  ICMJE November 30, 2018
First Posted Date  ICMJE December 5, 2018
Last Update Posted Date May 16, 2019
Actual Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2018)
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: December 4, 2018)
  • 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. We will use a generalized linear mixed effects model to test the intervention effect (intervention vs. usual care) by incorporating an "intervention versus usual" care dummy variable (which varies over patients within each surgeon), a surgeon random effect, a clinic-by-wave random effect, and a stratum-by-wave fixed effect as well as other fixed covariates including but not limited to an area deprivation index.
  • Patient power: active patient participation [ Time Frame: Up to 3 weeks ]
    Power, defined as patients' self-perceived capacity to influence the decision-making encounter, is also separately measured through active patient participation behaviors, a validated system to assess active patient participation during the surgeon consultation and is measured off the audio-recording of the consultation; a coding system by Street et al. is applied and the outcome measure is a count, 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); however, the consultation may occur within 5 days of registration. We will use a linear mixed effects model to test the intervention effect by incorporating an "intervention vs usual" care dummy variable (which varies over patients within each surgeon), a surgeon random effect, a clinic-by-wave random effect, a stratum-by-wave fixed effect, and other covariates including but not limited to an area deprivation index.
Change History Complete list of historical versions of study NCT03766009 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2018)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2018)
  • Patient knowledge [ Time Frame: Up to 3 weeks ]
    Patient knowledge is based on 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. We will use a generalized linear mixed effects model to test the intervention effect (intervention vs. usual care) by incorporating an "intervention versus usual" care dummy variable (which varies over patients within each surgeon), a surgeon random effect, a clinic-by-wave random effect, and a stratum-by-wave fixed effect as well as other fixed covariates including but not limited to an area deprivation index.
  • Concordance between values and surgery received [ Time Frame: Up to 3 weeks ]
    This secondary outcome is a binary outcome reflecting whether surgery received was in-line or not with the patient's personal values. The Decision Quality Instrument-Breast Surgery survey, which is a validated scale developed with the intent of assessing the extent to which patients were informed about breast cancer surgery and received treatment in-line with their personal values, will be used to determine concordance between personal values and surgery received. The patient completes the Decision Quality Instrument-Breast Surgery survey within 3 weeks post-surgical consultation. We will use a logistic random effects model for binary outcomes to test the intervention effect (intervention vs. usual care) by incorporating an "intervention versus usual" care dummy variable (which varies over patients within each surgeon), a surgeon random effect, a clinic-by-wave random effect, a stratum-by-wave fixed effect, and other covariates including but not limited to an area deprivation index.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Increasing Patients' Engagement in Breast Cancer Surgery Decision-Making
Official Title  ICMJE Increasing Socioeconomically Disadvantaged Patients' Engagement in Breast Cancer Surgery Decision Making Through a Shared Decision Making Intervention
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Institutional cross-over
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Breast Cancer Stage 0
  • Breast Cancer Stage I
  • Breast Cancer Stage II
  • Breast Cancer Stage III
Intervention  ICMJE
  • Other: Usual Care
    Usual Care
  • Other: Web-based decision aid
    Web-based decision aid received prior to the surgical consultation
Study Arms  ICMJE
  • Active Comparator: Arm I (surgical consultation)
    Prior to institutional crossover, participants receive care as per usual care.
    Intervention: 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..
    Interventions:
    • Other: Usual Care
    • Other: Web-based decision aid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 4, 2018)
1050
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Heather B. Neuman, MD, MS 608-265-5852 neuman@surgery.wisc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03766009
Other Study ID Numbers  ICMJE A231701CD
NCI-2018-00643 ( Registry Identifier: NCI Clinical Trial Reporting Program )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor  ICMJE Alliance for Clinical Trials in Oncology
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Agency for Healthcare Research and Quality (AHRQ)
Investigators  ICMJE
Study Chair: Heather B. Neuman,, MD, MS University of Wisconsin, Madison
PRS Account Alliance for Clinical Trials in Oncology
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP