Video Education With Result Dependent dIsclosure

Not Applicable

Recruiting

• Conditions: Genetic Testing; Ovarian Cancer; Pancreatic Cancer; Colorectal Cancer; Breast Cancer; Prostate Cancer; Renal Cancer; Melanoma; Sarcoma
• Interventions: Behavioral: Genetic Counseling; Behavioral: Video Education

• Registration Number: NCT05225428
• Lead Sponsor: Dana-Farber Cancer Institute

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.

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 Timeline

• Study First Submitted: 2021-12-21
• Study First Submitted QC: 2022-01-26
• Study First Posted: 2022-02-04
• Study Start: 2022-08-04
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1020

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RCT-Genetic Counseling	Genetic Counseling	A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling
QUALITATIVE ASSESSMENT	Video Education	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.
RCT-VERDI	Video Education	A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling

Primary Outcome Measures

Name	Time	Method
Video Education Acceptability (Qualitative Interview Study)	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.

Trial Locations

Locations (1)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States