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 18, 2023
|
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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 |
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
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 |
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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
Contact: Huma Q. Rana, MD. MPH | 617) 632-6292 | humaQ_rana@dfci.harvard.edu |
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 |
Principal Investigator: | Huma Q. Rana, MD., MPH | Dana-Farber Cancer Institute |
Responsible Party: | Huma Rana, MD, 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 18, 2023 |
Last Verified: | November 2023 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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