← Back to Search

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

Must not have

Prior cancer genetic testing

Active hematologic malignancy (e.g. chronic lymphocytic leukemia)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have or had breast, ovarian, pancreatic, prostate, colorectal, renal cancer, melanoma, or sarcoma.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have undergone genetic testing for cancer.

Select...

I have an active blood cancer, like chronic lymphocytic leukemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Video Education Acceptability (Qualitative Interview Study)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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