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New treatment option for Breast Cancer
Official title Breast Cancer Implementation Science Study With Educational Intervention
ClinicalTrials.gov ID: NCT06927895
What this study is testing
- What it's testing
- A study uniquely focused on system-based practice change, measuring the impact of educational interventions on both patients and clinicians for the recognition and management of treatment-related adverse effects for HER2+/HER2 low breast cancer patients on or about to start on HER2 targeted antibody drug conjugates (fam-trastuzumab deruxtecan-nxki or ado-trastuzumab emtansine) and shared decision-making methodologies to improve adverse event (AE) management and patient-clinician communications.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- , PATIENT participant group:
- ≥ 18 years of age
- Confirmed diagnosis of HER2+ or HER2 low breast cancer who are receiving or are about to receive HER2-targeted antibody drug conjugates (ADCs)
- Patient must be able to sign informed consent and be willing to participate in and comply with protocol requirements (3 visits [can be virtual]...
- Patient must be able to read, speak, and understand English
You likely can't join if
- , PATIENT participant group:
- History of noncompliance
- Inability to make required "office visits" (in-person or virtual)
- Inability to participate in training
- Non-ambulatory
- Limiting comorbidities (eg. psychiatric diagnosis; significant cognitive impairment limiting ability to fulfill protocol requirements)
See the full eligibility criteria
- , PATIENT participant group:
- ≥ 18 years of age
- Confirmed diagnosis of HER2+ or HER2 low breast cancer who are receiving or are about to receive HER2-targeted antibody drug conjugates (ADCs)
- Patient must be able to sign informed consent and be willing to participate in and comply with protocol requirements (3 visits [can be virtual], entry of survey information, access training, subset: 2 interviews and...
- Patient must be able to read, speak, and understand English
- Access to or ability to 1) enter information on computer or iPad into HIPAA-compliant Intelligent Dashboard online database; and 2) access training on computer or iPad , CLINICIAN participant group:
- Clinician agrees to see their own patients at study visits (baseline, interim time point, and end of study) in order to reduce inter-clinician variability that can affect result findings (observe effect of clinician's...
- Clinician is a physician, NP, physician assistant, nurse, or pharmacist who works with patients with HER2-positive or HER2-low breast cancer.
- Clinician must be willing to participate in and comply with protocol requirements and provide informed consent (per IRB requirements), including availability for interviews (3), case role plays (3), patient visits...
- Clinician agrees to access virtual online training videos: SDM, simulation case role play, management of adverse events for patients receiving HER2-targeted ADCs for HER2-positive or HER2-low breast cancer
- , PATIENT participant group:
- History of noncompliance
- Inability to make required "office visits" (in-person or virtual)
- Inability to participate in training
- Non-ambulatory
- Limiting comorbidities (eg. psychiatric diagnosis; significant cognitive impairment limiting ability to fulfill protocol requirements)
- Pregnant patients
- No internet and computer access Exclusion Criteria, CLINICIAN participant group:
- Inability to participate in required virtual visits, training, assessments, and other protocol requirements.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.