Genetic TestingVERDINCT05225428
Video Education With Result Dependent dIsclosure
A study testing Video Education and Genetic Counseling in people with Genetic Testing and Breast Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Genetic Testing, Breast Cancer, Ovarian Cancer
- What is being tested?
- Video Education and Genetic Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,334 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2022to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Prior cancer genetic testing
- Prior germline genetic testing
- Active hematologic malignancy (e.g. chronic lymphocytic leukemia)
- Currently pregnant
- Currently incarcerated
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
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.
Read the 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
- Conditions
- Genetic Testing, Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Colorectal Cancer
- Being tested
- Video Education, Genetic Counseling
- Keywords
- Genetic Testing, Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Colorectal Cancer, Renal Cancer, Melanoma, Sarcoma
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Prostatic Neoplasms, Colorectal Neoplasms, Kidney Neoplasms, Melanoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video EducationBehavioural
Also called VERDI
Investigator-developed, professionally animated and produced 8-minute video (Video Education) summarizing the core educational components of a genetic counseling visit
Genetic CounselingBehavioural
Standard genetic counseling
| Study group | Role | What they receive |
|---|---|---|
| QUALITATIVE ASSESSMENT | Experimental | 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. Receives: Behavioral: Video Education |
| RCT-VERDI | Experimental | A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling Receives: Behavioral: Video Education |
| RCT-Genetic Counseling | Experimental | A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling Receives: Behavioral: Genetic Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start4 Aug 2022
- Primary completion1 Sep 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic TestingStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Human Genome Research Institute (NHGRI)
- Responsible party
- Principal investigator, Huma Rana, MD, Dana-Farber Cancer Institute
- Investigators
- Huma Q. Rana, MD., MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225428
- Sponsor's protocol ID
- 21-508
- Other IDs
- R01HG011928
- Acronym
- VERDI
- Status last verified
- Sep 2025
- First submitted
- 21 Dec 2021
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Education With Result Dependent dIsclosure
- ClinicalTrials.gov ID
- NCT05225428
- Acronym / sponsor ID
- VERDI / 21-508
- Conditions
- Genetic Testing, Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Colorectal Cancer
- Keywords
- Genetic Testing, Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Colorectal Cancer, Renal Cancer, Melanoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,334 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Human Genome Research Institute (NHGRI)
- Study start
- 4 Aug 2022 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| QUALITATIVE ASSESSMENT | Experimental | Behavioral: Video EducationThis 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. |
| RCT-VERDI | Experimental | Behavioral: Video EducationA randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling |
| RCT-Genetic Counseling | Experimental | Behavioral: Genetic CounselingA randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- Prior cancer genetic testing
- Prior germline genetic testing
- Active hematologic malignancy (e.g. chronic lymphocytic leukemia)
- Currently pregnant
- Currently incarcerated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video EducationAlso: VERDIInvestigator-developed, professionally animated and produced 8-minute video (Video Education) summarizing the core educational components of a genetic counseling visit | Behavioural | QUALITATIVE ASSESSMENT, RCT-VERDI |
| Genetic CounselingStandard genetic counseling | Behavioural | RCT-Genetic Counseling |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huma Q. Rana, MD., MPH principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Education and Genetic Counseling in people with Genetic Testing and Breast Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Video Education Acceptability (Qualitative Interview Study) (time frame: 3 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.