Video Education With Result Dependent dIsclosure

NCT ID: NCT05225428

Last Updated: 2025-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1020 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-04

Study Completion Date

2026-09-01

Brief Summary

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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.

Detailed Description

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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

Conditions

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Genetic Testing Breast Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer Colorectal Cancer Renal Cancer Melanoma Sarcoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Video Education

Intervention Type BEHAVIORAL

Investigator-developed, professionally animated and produced 8-minute video (Video Education) summarizing the core educational components of a genetic counseling visit

RCT-VERDI

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

Group Type EXPERIMENTAL

Video Education

Intervention Type BEHAVIORAL

Investigator-developed, professionally animated and produced 8-minute video (Video Education) summarizing the core educational components of a genetic counseling visit

RCT-Genetic Counseling

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

Group Type EXPERIMENTAL

Genetic Counseling

Intervention Type BEHAVIORAL

Standard genetic counseling

Interventions

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Video Education

Investigator-developed, professionally animated and produced 8-minute video (Video Education) summarizing the core educational components of a genetic counseling visit

Intervention Type BEHAVIORAL

Genetic Counseling

Standard genetic counseling

Intervention Type BEHAVIORAL

Other Intervention Names

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VERDI

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

National Human Genome Research Institute (NHGRI)

NIH

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Huma Rana, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Huma Q. Rana, MD., MPH

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Huma Q. Rana, MD. MPH

Role: CONTACT

617) 632-6292

Facility Contacts

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Huma Q Rana, MD

Role: primary

617-632-6292

Other Identifiers

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R01HG011928

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-508

Identifier Type: -

Identifier Source: org_study_id

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