Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1020 participants
INTERVENTIONAL
2022-08-04
2026-09-01
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
Video Education
Investigator-developed, professionally animated and produced 8-minute video (Video Education) summarizing the core educational components of a genetic counseling visit
RCT-VERDI
A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling
Video Education
Investigator-developed, professionally animated and produced 8-minute video (Video Education) summarizing the core educational components of a genetic counseling visit
RCT-Genetic Counseling
A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling
Genetic Counseling
Standard genetic counseling
Interventions
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Video Education
Investigator-developed, professionally animated and produced 8-minute video (Video Education) summarizing the core educational components of a genetic counseling visit
Genetic Counseling
Standard genetic counseling
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 germline genetic testing
* Active hematologic malignancy (e.g. chronic lymphocytic leukemia)
* Currently pregnant
* Currently incarcerated
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
National Human Genome Research Institute (NHGRI)
NIH
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Huma Rana, MD
Principal Investigator
Principal Investigators
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Huma Q. Rana, MD., MPH
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Dana Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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21-508
Identifier Type: -
Identifier Source: org_study_id
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