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Video Education With Result Dependent dIsclosure (VERDI)

Primary Purpose

Genetic Testing, Breast Cancer, Ovarian Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video Education
Genetic Counseling
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Genetic Testing focused on measuring Genetic Testing, Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Colorectal Cancer, Renal Cancer, Melanoma, Sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Dana Farber Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

QUALITATIVE ASSESSMENT

RCT-VERDI

RCT-Genetic Counseling

Arm 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.

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

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

Outcomes

Primary Outcome Measures

Video Education Acceptability (Qualitative Interview Study)
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.

Secondary Outcome Measures

Full Information

First Posted
December 21, 2021
Last Updated
October 31, 2022
Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI), National Human Genome Research Institute (NHGRI)
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1. Study Identification

Unique Protocol Identification Number
NCT05225428
Brief Title
Video Education With Result Dependent dIsclosure
Acronym
VERDI
Official Title
Video Education With Result Dependent dIsclosure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 4, 2022 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
September 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI), National Human Genome Research Institute (NHGRI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genetic Testing, Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Colorectal Cancer, Renal Cancer, Melanoma, Sarcoma
Keywords
Genetic Testing, Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Colorectal Cancer, Renal Cancer, Melanoma, Sarcoma

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1020 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
QUALITATIVE ASSESSMENT
Arm Type
Experimental
Arm 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.
Arm Title
RCT-VERDI
Arm Type
Experimental
Arm Description
A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling
Arm Title
RCT-Genetic Counseling
Arm Type
Experimental
Arm Description
A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling
Intervention Type
Behavioral
Intervention Name(s)
Video Education
Other Intervention Name(s)
VERDI
Intervention Description
Investigator-developed, professionally animated and produced 8-minute video (Video Education) summarizing the core educational components of a genetic counseling visit
Intervention Type
Behavioral
Intervention Name(s)
Genetic Counseling
Intervention Description
Standard genetic counseling
Primary Outcome Measure Information:
Title
Video Education Acceptability (Qualitative Interview Study)
Description
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.
Time Frame
3 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huma Q. Rana, MD. MPH
Phone
617) 632-6292
Email
humaQ_rana@dfci.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huma Q. Rana, MD., MPH
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huma Q Rana, MD
Phone
617-632-6292
Email
HumaQ_Rana@DFCI.HARVARD.EDU
First Name & Middle Initial & Last Name & Degree
Huma Q Rana, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Learn more about this trial

Video Education With Result Dependent dIsclosure

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