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Video Education With Result Dependent dIsclosure (VERDI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05225428
Recruitment Status : Recruiting
First Posted : February 4, 2022
Last Update Posted : November 1, 2022
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Human Genome Research Institute (NHGRI)
Information provided by (Responsible Party):
Huma Rana, Dana-Farber Cancer Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Genetic Testing Breast Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer Colorectal Cancer Renal Cancer Melanoma Sarcoma Behavioral: Video Education Behavioral: Genetic Counseling Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1020 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Video Education With Result Dependent dIsclosure
Actual Study Start Date : August 4, 2022
Estimated Primary Completion Date : September 1, 2025
Estimated Study Completion Date : September 1, 2026


Arm Intervention/treatment
Experimental: 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.

Behavioral: Video Education
Investigator-developed, professionally animated and produced 8-minute video (Video Education) summarizing the core educational components of a genetic counseling visit
Other Name: VERDI

Experimental: RCT-VERDI
A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling
Behavioral: Video Education
Investigator-developed, professionally animated and produced 8-minute video (Video Education) summarizing the core educational components of a genetic counseling visit
Other Name: VERDI

Experimental: RCT-Genetic Counseling
A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling
Behavioral: Genetic Counseling
Standard genetic counseling




Primary Outcome Measures :
  1. Video Education Acceptability (Qualitative Interview Study) [ Time Frame: 3 Weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05225428


Contacts
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Contact: Huma Q. Rana, MD. MPH 617) 632-6292 humaQ_rana@dfci.harvard.edu

Locations
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United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Huma Q Rana, MD    617-632-6292    HumaQ_Rana@DFCI.HARVARD.EDU   
Principal Investigator: Huma Q Rana, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
National Human Genome Research Institute (NHGRI)
Investigators
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Principal Investigator: Huma Q. Rana, MD., MPH Dana-Farber Cancer Institute
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Responsible Party: Huma Rana, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT05225428    
Other Study ID Numbers: 21-508
R01HG011928 ( U.S. NIH Grant/Contract )
First Posted: February 4, 2022    Key Record Dates
Last Update Posted: November 1, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data can be shared no earlier than 1 year following the date of publication
Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Huma Rana, Dana-Farber Cancer Institute:
Genetic Testing
Breast Cancer
Ovarian Cancer
Pancreatic Cancer
Prostate Cancer
Colorectal Cancer
Renal Cancer
Melanoma
Sarcoma
Additional relevant MeSH terms:
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Prostatic Neoplasms
Colorectal Neoplasms
Melanoma
Pancreatic Neoplasms
Ovarian Neoplasms
Sarcoma
Kidney Neoplasms
Carcinoma, Renal Cell
Neoplasms by Site
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Prostatic Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases