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2022-08-04
2025-09-01
2026-09-01
1020
NCT05225428
Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
INTERVENTIONAL
Video Education With Result Dependent dIsclosure
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-12-21 | N/A | 2024-11-20 |
2022-01-26 | N/A | 2024-11-22 |
2022-02-04 | N/A | 2024-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Health Services Research
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/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 digita | BEHAVIORAL: Video Education
|
| EXPERIMENTAL: RCT-VERDI A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling | BEHAVIORAL: Video Education
|
| EXPERIMENTAL: RCT-Genetic Counseling A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling | BEHAVIORAL: Genetic Counseling
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | 3 Weeks |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Huma Q. Rana, MD. MPH Phone Number: 617) 632-6292 Email: humaQ_rana@dfci.harvard.edu |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
