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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

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.

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

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1050 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Arm I (surgical consultation)
Prior to institutional crossover, participants receive care as per usual care.
Other: Usual Care
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
Usual Care

Other: Web-based decision aid
Web-based decision aid received prior to the surgical consultation




Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Heather B. Neuman, MD, MS 608-265-5852 neuman@surgery.wisc.edu

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Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Agency for Healthcare Research and Quality (AHRQ)
Investigators
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Study Chair: Heather B. Neuman,, MD, MS University of Wisconsin, Madison

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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT03766009     History of Changes
Other Study ID Numbers: A231701CD
NCI-2018-00643 ( Registry Identifier: NCI Clinical Trial Reporting Program )
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Breast Neoplasms
Breast Carcinoma In Situ
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type