Educational Intervention for HER2+ or HER2 low Breast Cancer

This study is testing an educational program designed to improve how patients and doctors communicate about managing side effects from breast cancer treatments. Specifically, it focuses on patients with HER2-positive or HER2 low breast cancer who are receiving or about to start specific antibody drug conjugates (ADCs) like fam-trastuzumab deruxtecan-nxki or ado-trastuzumab emtansine. The program includes videos on shared decision-making (SDM) to help you and your doctor work together on your care. Researchers will measure if this education helps reduce decisional conflict (how unsure you feel about treatment decisions) at the start, 3 months, and 6 months into the study. The study is looking for 30 participants and its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive an intervention. It plans to enroll 30 participants.
What's involved
You would have 3 visits (which can be virtual) and complete survey information.
Compensation
Not stated in the trial record.
Follow-up
Your decisional conflict will be measured at baseline, 3 months, and 6 months.

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NCT06927895

Breast Cancer Implementation Science Study With Educational Intervention

Recruiting
NAAges 18+InterventionalSupportive care
NYU Langone Health
~30 participants
Updated 2026-03-30 on ClinicalTrials.gov
What's tested:Educational Intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Decisional Conflict Scale (DCS) Score
Measured over Baseline
+8 more outcomes measured
Breast Cancer
1 sites across 1 states
New York1
  • Nancy Chan, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

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Eligibility criteria

Inclusion

≥ 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 focus group) \[All Virtual\]
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 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 education on their patients' learning.)
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 (3/patient), and training
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

Exclusion

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
  • Decisional Conflict Scale (DCS) ScoreBaseline

    16-item assessment of a person's uncertainty in making a healthcare choice. Each item is rated on a 5-point Likert scale from 0 (strongly agree) to 4 (strongly disagree). The total score is the sum of responses and ranges from 0-64; lower scores indicate less uncertainty. Assessed among patients only.

  • Decisional Conflict Scale (DCS) ScoreMonth 3

    16-item assessment of a person's uncertainty in making a healthcare choice. Each item is rated on a 5-point Likert scale from 0 (strongly agree) to 4 (strongly disagree). The total score is the sum of responses and ranges from 0-64; lower scores indicate less uncertainty. Assessed among patients only.

  • Decisional Conflict Scale (DCS) ScoreMonth 6

    16-item assessment of a person's uncertainty in making a healthcare choice. Each item is rated on a 5-point Likert scale from 0 (strongly agree) to 4 (strongly disagree). The total score is the sum of responses and ranges from 0-64; lower scores indicate less uncertainty. Assessed among patients only.

  • Patient HER2-Targeted ADC Related Side Effect Pre-Test ScoreBaseline

    6 questions assessing ability to recognize HER2-targeted ADC-related AEs and how they are managed. 4 items are multiple choice questions with (1) correct answer. The final 2 items are rated on a Likert scale from 5 (Always) to 1 (Never). The score is calculated as the sum of (a) total correct answers to items 1-4 and (b) responses to items 5-6. The total score ranges from 2-14; higher scores indicate greater ability to recognize HER2-targeted ADC-related AEs and how they are managed.

  • Patient HER2-Targeted ADC Related Side Effect Post-Test ScoreMonth 3

    6 questions assessing ability to recognize HER2-targeted ADC-related AEs and how they are managed. 4 items are multiple choice questions with (1) correct answer. The final 2 items are rated on a Likert scale from 5 (Always) to 1 (Never). The score is calculated as the sum of (a) total correct answers to items 1-4 and (b) responses to items 5-6. The total score ranges from 2-14; higher scores indicate greater ability to recognize HER2-targeted ADC-related AEs and how they are managed.

  • Patient HER2-Targeted ADC Related Side Effect Post-Test ScoreMonth 6

    6 questions assessing ability to recognize HER2-targeted ADC-related AEs and how they are managed. 4 items are multiple choice questions with (1) correct answer. The final 2 items are rated on a Likert scale from 5 (Always) to 1 (Never). The score is calculated as the sum of (a) total correct answers to items 1-4 and (b) responses to items 5-6. The total score ranges from 2-14; higher scores indicate greater ability to recognize HER2-targeted ADC-related AEs and how they are managed.

  • Clinician HER2-Targeted ADC Related Side Effect Pre-Test ScoreBaseline

    7 questions assessing ability to recognize HER2-targeted ADC-related AEs and how they are managed. 5 items are multiple choice questions with (1) correct answer. The final 2 items are rated on a Likert scale from 5 (Always) to 1 (Never). The score is calculated as the sum of (a) total correct answers to items 1-5 and (b) responses to items 6-7. The total score ranges from 2-15; higher scores indicate greater ability to recognize HER2-targeted ADC-related AEs and how they are managed.

  • Clinician HER2-Targeted ADC Related Side Effect Post-Test ScoreMonth 3

    7 questions assessing ability to recognize HER2-targeted ADC-related AEs and how they are managed. 5 items are multiple choice questions with (1) correct answer. The final 2 items are rated on a Likert scale from 5 (Always) to 1 (Never). The score is calculated as the sum of (a) total correct answers to items 1-5 and (b) responses to items 6-7. The total score ranges from 2-15; higher scores indicate greater ability to recognize HER2-targeted ADC-related AEs and how they are managed.

  • Clinician HER2-Targeted ADC Related Side Effect Post-Test ScoreMonth 6

    7 questions assessing ability to recognize HER2-targeted ADC-related AEs and how they are managed. 5 items are multiple choice questions with (1) correct answer. The final 2 items are rated on a Likert scale from 5 (Always) to 1 (Never). The score is calculated as the sum of (a) total correct answers to items 1-5 and (b) responses to items 6-7. The total score ranges from 2-15; higher scores indicate greater ability to recognize HER2-targeted ADC-related AEs and how they are managed.