Video Education With Result Dependent dIsclosure (VERDI)

Dana-Farber Cancer Institute

Status: Enrolling

Conditions: Breast Cancer; Sarcoma; Melanoma; Genetic Testing; Renal Cancer; Ovarian Cancer; Prostate Cancer; Colorectal Cancer; Pancreatic Cancer

Treatments: Behavioral: Genetic Counseling; Behavioral: Video Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05225428

R01HG011928 (U.S. NIH Grant/Contract)

21-508

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,020 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,020 participants in 3 patient groups

QUALITATIVE ASSESSMENT

Experimental group

Description:

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.

Treatment:

Behavioral: Video Education

RCT-VERDI

Experimental group

Description:

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

Treatment:

Behavioral: Video Education

RCT-Genetic Counseling

Experimental group

Description:

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

Treatment:

Behavioral: Genetic Counseling