Video Education With Result Dependent dIsclosure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Video Education, Genetic Counseling.
- Who it may be relevant to
- Registry conditions: Genetic Testing, Breast Cancer, Ovarian Cancer, Pancreatic Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Behavioral Video Education
Investigator-developed, professionally animated and produced 8-minute video (Video Education) summarizing the core educational components of a genetic counseling visit - Behavioral Genetic Counseling
Standard genetic counseling
Primary outcome measures
- Video Education Acceptability (Qualitative Interview Study) [Time frame: 3 Weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Dana Farber Cancer Institute — Boston
Identifiers
NCT: NCT05225428 · 21-508 · R01HG011928