Video Education With Result Dependent dIsclosure

Study Overview
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Brief Summary
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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
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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

Official Title
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Video Education With Result Dependent dIsclosure

Conditions
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Genetic Testing, Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Colorectal Cancer, Renal Cancer, Melanoma, Sarcoma

Intervention / Treatment
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* Behavioral: Video Education
* Behavioral: Genetic Counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QUALITATIVE ASSESSMENT<br>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. | Behavioral: Video Education<br>* Investigator-developed, professionally animated and produced 8-minute video (Video Education) summarizing the core educational components of a genetic counseling visit<br>* Other names: VERDI;|
| Experimental: RCT-VERDI<br>A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling | Behavioral: Video Education<br>* Investigator-developed, professionally animated and produced 8-minute video (Video Education) summarizing the core educational components of a genetic counseling visit<br>* Other names: VERDI;|
| Experimental: RCT-Genetic Counseling<br>A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling | Behavioral: Genetic Counseling<br>* Standard genetic counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genetic Testing, Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Colorectal Cancer, Renal Cancer, Melanoma, Sarcoma