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Genetic Counseling + Video Education for Hereditary Cancer (VERDI Trial)
N/A
Recruiting
Led By Huma Q. Rana, MD., MPH
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Current or prior diagnosis of breast cancer, ovarian cancer, pancreatic cancer, prostate cancer, colorectal cancer, renal cancer, melanoma, or sarcoma
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks
Awards & highlights
VERDI Trial Summary
This trial study is trying to find ways to make the VERDI model more accessible to a more diverse group of people who are at risk for hereditary cancers.
Who is the study for?
This trial is for adults over 18 who speak English or Spanish and have been diagnosed with certain cancers like breast, ovarian, pancreatic, prostate, colorectal cancer, renal cancer, melanoma or sarcoma. It's not for those who've had genetic testing before, are pregnant or incarcerated.Check my eligibility
What is being tested?
The study tests a video education model called VERDI used before genetic testing to see if it can be improved to help a diverse group of patients at risk for hereditary cancers understand their condition better.See study design
What are the potential side effects?
Since the interventions involve counseling and education rather than medical treatments or drugs, there are no direct physical side effects. However, learning about one's genetic risks could potentially cause emotional or psychological distress.
VERDI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have or had breast, ovarian, pancreatic, prostate, colorectal, renal cancer, melanoma, or sarcoma.
Select...
I am 18 years old or older.
VERDI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Video Education Acceptability (Qualitative Interview Study)
VERDI Trial Design
3Treatment groups
Experimental Treatment
Group I: RCT-VERDIExperimental Treatment1 Intervention
A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling
Group II: RCT-Genetic CounselingExperimental Treatment1 Intervention
A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling
Group III: QUALITATIVE ASSESSMENTExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Genetic Counseling
2008
Completed Phase 3
~5170
Video Education
2017
N/A
~710
Find a Location
Who is running the clinical trial?
National Human Genome Research Institute (NHGRI)NIH
263 Previous Clinical Trials
283,112 Total Patients Enrolled
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13,240 Patients Enrolled for Prostate Cancer
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
339,961 Total Patients Enrolled
76 Trials studying Prostate Cancer
15,085 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,924,834 Total Patients Enrolled
560 Trials studying Prostate Cancer
506,075 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have undergone genetic testing for cancer.I have or had breast, ovarian, pancreatic, prostate, colorectal, renal cancer, melanoma, or sarcoma.Only Black or Latinx individuals can participate in the qualitative assessment study.I have an active blood cancer, like chronic lymphocytic leukemia.I have had genetic testing for inherited conditions.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: QUALITATIVE ASSESSMENT
- Group 2: RCT-VERDI
- Group 3: RCT-Genetic Counseling
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently enrolled in this clinical investigation?
"Affirmative. According to clinicaltrials.gov, this medical trial was initially uploaded on August 4th 2022 and is actively inviting participants at the time of writing. The research program requires 1020 patients from a single site to join in its investigations."
Answered by AI
Is enrollment for this research study currently open to the public?
"Clinicaltrials.gov reports this clinical trial is presently recruiting patients. Initially posted on August 4th 2022, the study was last edited on October 31st of that same year."
Answered by AI
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