| Registry | NCT05225428, acronym VERDI |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, health services research |
| Enrollment | 1334 (Actual) |
| Sponsor | Dana-Farber Cancer Institute (Other); collaborators: National Cancer Institute (NCI), National Human Genome Research Institute (NHGRI) |
| Conditions | Genetic Testing, Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Colorectal Cancer, Renal Cancer, Melanoma, Sarcoma |
| Interventions | Video Education, Genetic Counseling (Behavioral) |
| Dates | start 2022-08-04, primary completion 2026-09-01, completion 2026-09-01, first posted 2022-02-04, last updated 2026-10-19 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Genetic Testing All trials for Breast Cancer All trials of Video Education All trials of Genetic Counseling
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.
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| QUALITATIVE ASSESSMENT | Experimental | Behavioral: 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 | Experimental | Behavioral: Video Education | A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling |
| RCT-Genetic Counseling | Experimental | Behavioral: Genetic Counseling | A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Dana Farber Cancer Institute | Boston, Massachusetts | United States |
NIH grants: R01HG011928