Improving Patient-Centered Communication in Breast Cancer: A RCT of a Shared Decision Engagement System (SHARES)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 543
- Locations
- 54
- Primary Endpoint
- Patient knowledge about risks and benefits of local regional treatment
Study Overview
Brief Summary
This trial studies the effectiveness of two interventions on patient reported outcomes of patient centered communication and decision making about breast cancer treatment. The first intervention consists of enhancements to an existing patient-facing breast cancer treatment decision tool called iCanDecide that supports the management of worry, distress, and anxiety as compared to an existing tool. The second intervention consists of a clinician dashboard that populates information after patients view either website regarding any ongoing issues or concerns.
Detailed Description
The primary and key secondary objectives of the study:
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Health Services Research
- Masking
- Double (Participant, Care Provider)
Masking Description
The enhanced content of the ESE version iCanDecide-ESE is available to the patient, but does not populate differently into the CDB, allowing clinicians to remain blinded to the patient-level randomization arm; therefore, both the patient and the practice and clinicians will be blinded as to which arm the patient is assigned to. However, the surgical practices and their clinicians will know when they are using the CDB so the clinician level intervention will not be blinded.
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •PATIENT ELIGIBILITY
- •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
Outcomes
Primary Outcomes
Patient knowledge about risks and benefits of local regional treatment
Time Frame: At 4-5 weeks post patient randomization
Will be defined as the percentage of correct answers (range: 0-100%) from a 5-item scale previously developed and pilot tested where higher percentages indicate increased knowledge of treatment risks and benefits of local regional treatment. Because the interventions are fully crossed (with intervention and control patients within both intervention and control practices for every time period), the intervention effect of iCanDecide-E and the intervention effect of the clinician dashboard (CDB) will be obtained from a single linear mixed-effects model for the continuous primary outcome measure patient knowledge.
Secondary Outcomes
- Patient self-efficacy in dealing with breast cancer(At 4-5 weeks post patient randomization)
- Patient cancer worry(At 4-5 weeks post patient randomization)