Breast Cancer Clinical Trial

Video Education With Result Dependent dIsclosure

Summary

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.

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Full 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

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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

Study is for people with:

Breast Cancer

Estimated Enrollment:

1020

Study ID:

NCT05225428

Recruitment Status:

Recruiting

Sponsor:

Dana-Farber Cancer Institute

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There is 1 Location for this study

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Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States More Info
Huma Q Rana, MD
Contact
617-632-6292
[email protected]
Huma Q Rana, MD
Principal Investigator

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Study is for people with:

Breast Cancer

Estimated Enrollment:

1020

Study ID:

NCT05225428

Recruitment Status:

Recruiting

Sponsor:


Dana-Farber Cancer Institute

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