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Improving Patient-Centered Communication in Breast Cancer: A RCT of a Shared Decision Engagement System (SHARES)

NCT No.: NCT04549571

Study Type: INTERVENTIONAL

Phase: n/a

Region: California - Northern

Acronym: 

Official Title

Improving Patient-Centered Communication in Breast Cancer: A RCT of a Shared Decision Engagement System (SHARES)

Purpose

I. To demonstrate that the enhanced iCanDecide (iCanDecide-emotional support enhancement [ESE]) intervention is more effective than the standard version (iCanDecide-standard [S]) resulting in higher patient knowledge about locoregional treatment risks and benefits. II. To demonstrate that the activation of the clinician dashboard (CDB) is more effective than not using a CDB, resulting in higher patient knowledge about locoregional treatment risks and benefits.

Detailed Description

Sex

Male & Female

Age Limit

Eligibility Criteria

Inclusion Criteria

; Women newly diagnosed with stage 0-III breast cancer. Although men are recommended to undergo surgery to treat breast cancer, male breast cancer is relatively rare and decision making for breast cancer surgery is quite different between men and women

; Planning breast surgery as a component of their definitive treatment within 5 weeks of registration

; Receives care from a clinician and at a practice that has consented to participate in the clinician dashboard practice-level intervention. Practices/clinicians will consent initially at the initiation of the study. Patients will then be identified and recruited in those practices. If a practice has more than one clinician doing breast surgery, patients will be recruited from those clinicians who consent (one or more). Patients of clinicians who have not consented will not be eligible

; Patients must be able to speak English or Spanish with the fluency required to have a direct discussion around treatment decision-making (i.e. without interpreter)

; Age 21-84 years

; CLINICIAN STAKEHOLDER (SURGEONS AND CLINIC STAFF) ELIGIBILITY CRITERIA

; Clinicians eligible for this study include: breast surgeons and their designee(s) (e.g., physician assistants, nurse practitioners, clinical nurse specialists, or nurses) that participate in the treatment decision-making process. At least one surgical oncologist at a practice must agree to participate and sign consent. S/he may then also identify a nurse, physician assistant (PA) or advanced practice provider (APP) with whom s/he works that is involved in the delivery of the care of the same patients to participate. Henceforth, in this protocol they will be referred to as "clinicians"

; Clinicians must agree to have their patients recruited for the entire time the study is open at their practice, which will include time periods in which the clinicians will and time periods in which they will not have access to the CDB

; INSTITUTION ELIGIBILITY:

; Practices that annually provide surgical care for over 100 patients newly diagnosed with breast cancer are eligible to participate in this study

; Eligible practices must have at least one surgical oncologist who agrees to participate in the study

Exclusion Criteria

Patients who are visually impaired are not eligible, as they must be able to access the study intervention on a website at home or in clinic and view the decision aid; Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study; Practices currently enrolling to Alliance A231701CD are not eligible to participate in this study

Keywords and/or Specific Medical Conditions

  • Obstetrics and Gynecology
  • Oncology (Adult)

Sponsors

  • Alliance for Clinical Trials in Oncology

KP Clinical Facility

Clinical Area

  • Obstetrics and Gynecology
  • Oncology (Adult)

Principal Investigator

Samantha Seaward  

Contact Information

 - CTP Collaborate Team
- CTPCollaborate@kp.org
- Central Valley-Manteca

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