Video Education With Result Dependent dIsclosure (VERDI)

May 20, 2026 updated by: Huma Rana, MD, Dana-Farber Cancer Institute
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study consists of two parts:

  • Qualitative assessment:

    • This 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. Participation in the study will be considered complete after the interview is finished. The qualitative assessment study will recruit 20 total participants.
    • The data gathered from this study will inform the refinement and adaptation of the VERDI model for the subsequent randomized controlled trial.

  • Randomized control trial:

    • A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling in 1000 participants

Study Type

Interventional

Enrollment (Estimated)

1020

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Dana Farber Cancer Institute
        • Contact:
        • Principal Investigator:
          • Huma Q Rana, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Prior cancer genetic testing
  • Prior germline genetic testing
  • Active hematologic malignancy (e.g. chronic lymphocytic leukemia)
  • Currently pregnant
  • Currently incarcerated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QUALITATIVE ASSESSMENT

This 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.
Behavioral: Video Education
Investigator-developed, professionally animated and produced 8-minute video (Video Education) summarizing the core educational components of a genetic counseling visit
Other Names:
  • VERDI
Experimental: RCT-VERDI
A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling
Behavioral: Video Education
Investigator-developed, professionally animated and produced 8-minute video (Video Education) summarizing the core educational components of a genetic counseling visit
Other Names:
  • VERDI
Experimental: RCT-Genetic Counseling
A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling
Behavioral: Genetic Counseling
Standard genetic counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Video Education Acceptability (Qualitative Interview Study)
Time Frame: 3 Weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

National Cancer Institute (NCI)
National Human Genome Research Institute (NHGRI)

Investigators

  • Principal Investigator: Huma Q. Rana, MD., MPH, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2022

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

December 21, 2021

First Submitted That Met QC Criteria

January 26, 2022

First Posted (Actual)

February 4, 2022

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-508
  • R01HG011928 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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