Recruiting

Observational Study

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT05225428

Conditions

Genetic Testing

Breast Cancer

Ovarian Cancer

Pancreatic Cancer

Prostate Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Video Education

Genetic Counseling

Study Details

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.

Conditions

Genetic Testing

Breast Cancer

Ovarian Cancer

Pancreatic Cancer

Prostate Cancer

Study ID

NCT05225428

Start date

Aug 4, 2022

Status verified date

Sep, 2025

Completion date

Oct 1, 2026

Anticipated

Primary completion date

Aug 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1020 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

experimental: RCT-VERDI

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

experimental: RCT-Genetic Counseling

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

Interventions

Video Education

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

Genetic Counseling

Standard genetic counseling

Primary outcome measure

  • Video Education Acceptability (Qualitative Interview Study) [ Time Frame: 3 Weeks ]

Central Contacts and Locations

Central contacts

Huma Q. Rana, MD. MPH

617) 632-6292humaQ_rana@dfci.harvard.edu

Locations

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Huma Q Rana, MD

617-632-6292HumaQ_Rana@DFCI.HARVARD.EDU

Principal Investigator:

Huma Q Rana, MD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

May 22, 2026

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-05-22.