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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05225428
Other study ID # 21-508
Secondary ID R01HG011928
Status Recruiting
Phase N/A
First received
Last updated
Start date August 4, 2022
Est. completion date September 1, 2026

Study information

Verified date November 2023
Source Dana-Farber Cancer Institute
Contact Huma Q. Rana, MD. MPH
Phone 617) 632-6292
Email humaQ_rana@dfci.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 1020
Est. completion date September 1, 2026
Est. primary completion date September 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
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

Locations

Country Name City State
United States Dana Farber Cancer Institute Boston Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Dana-Farber Cancer Institute National Cancer Institute (NCI), National Human Genome Research Institute (NHGRI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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