Video Education With Result Dependent dIsclosure
Status
RECRUITING
Phase
NA
Age
≥ 18 Years
Enrollments
1020Conditions
Genetic Testing, Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Colorectal Cancer, Renal Cancer, Melanoma, SarcomaSummary
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
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Huma Q Rana, MD
- 617-632-6292
- [email protected]
Principal Investigator
- Huma Q. Rana, MD., MPH
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
Study Plan
QUALITATIVE ASSESSMENT
EXPERIMENTAL
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.nnIt is expected that about 20 people will take part in this part of the research study.nnIn the larger part of the study that will happen after this part of the study, it is expected 1000 people will participate.
BEHAVIORAL:
Video EducationDescription:
Investigator-developed, professionally animated and produced 8-minute video (Video Education) summarizing the core educational components of a genetic counseling visit
RCT-VERDI
EXPERIMENTAL
A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling
BEHAVIORAL:
Video EducationDescription:
Investigator-developed, professionally animated and produced 8-minute video (Video Education) summarizing the core educational components of a genetic counseling visit
RCT-Genetic Counseling
EXPERIMENTAL
A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling
BEHAVIORAL:
Genetic CounselingDescription:
Standard genetic counseling
Outcome Measures
Primary Outcome Measures
Video Education Acceptability (Qualitative Interview Study)
Timeline
Last Updated
November 22, 2024Start Date
February 4, 2022Today
January 16, 2025Completion Date ( Estimated )
September 1, 2026
Sponsors of this trial
Lead Sponsor
Dana-Farber Cancer InstituteCollaborating Sponsors
National Cancer Institute (NCI), National Human Genome Research Institute (NHGRI)
RECRUITING 
21 - 64 Years