Video Education With Result Dependent dIsclosure
VERDI
2 other identifiers
interventional
1,020
1 country
1
Brief Summary
The overall study objective of this trial study is to identify and evaluate strategies to improve the accessibility of the video education with result dependent disclosure (VERDI) model, increasingly utilized as a pre-genetic testing (pretest) education alternative in clinical practice, to better serve a more diverse patient population at risk for hereditary cancers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2021
CompletedFirst Posted
Study publicly available on registry
February 4, 2022
CompletedStudy Start
First participant enrolled
August 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedFebruary 25, 2026
September 1, 2025
3.7 years
December 21, 2021
February 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Video Education Acceptability (Qualitative Interview Study)
Pre- and post-test of knowledge of hereditary cancer risk and cancer genetic counseling with qualitative patient interview question domains and instruments to assess understanding of language and imagery of video education as correlated with measures of health literacy.
3 Weeks
Study Arms (3)
QUALITATIVE ASSESSMENT
EXPERIMENTALThis part of the research study involves watching a brief educational video about genetic testing for inherited cancer risk (about 8 minutes) before completing a short interview by video or telephone with trained researchers. This interview will be digitally recorded for later review. It is expected that about 20 people will take part in this part of the research study. In the larger part of the study that will happen after this part of the study, it is expected 1000 people will participate.
RCT-VERDI
EXPERIMENTALA randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling
RCT-Genetic Counseling
EXPERIMENTALA randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling
Interventions
Investigator-developed, professionally animated and produced 8-minute video (Video Education) summarizing the core educational components of a genetic counseling visit
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Current or prior diagnosis of breast cancer, ovarian cancer, pancreatic cancer, prostate cancer, colorectal cancer, renal cancer, melanoma, or sarcoma
- Ability to understand spoken or written English or Spanish in a healthcare context
- Ability to understand and the willingness to sign a written informed consent document
- Black or Latinx (qualitative assessment study only)
You may not qualify if:
- Prior cancer genetic testing
- Prior germline genetic testing
- Active hematologic malignancy (e.g. chronic lymphocytic leukemia)
- Currently pregnant
- Currently incarcerated
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- National Cancer Institute (NCI)collaborator
- National Human Genome Research Institute (NHGRI)collaborator
Study Sites (1)
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Huma Q. Rana, MD., MPH
Dana-Farber Cancer Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 21, 2021
First Posted
February 4, 2022
Study Start
August 4, 2022
Primary Completion
April 30, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
February 25, 2026
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.