VERDI: Video Education With Result Dependent dIsclosure

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05225428

Collaborator

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

1,020

Enrollment

Location

Arms

Anticipated Duration (Months)

20.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Genetic Testing Breast Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer Colorectal Cancer Renal Cancer Melanoma Sarcoma	Behavioral: Video Education Behavioral: Genetic Counseling	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1020 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Video Education With Result Dependent dIsclosure

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)