Educational Video Versus In-person Genetic Counseling for Hereditary Cancer

Hereditary Cancer Clinical Trial

Official title:

Randomized Non Inferiority Trial of Educational Video Versus In-person Genetic Counseling for Hereditary Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05805982
• Other study ID #: HEM-3442
• Status: Completed
• Phase: N/A
• Start date: August 10, 2020
• Est. completion date: January 3, 2023

Study information

• Verified date: April 2023
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The identification of mutations in cancer susceptibility genes is important as it makes it possible to recommend specific cancer treatments, implement risk reduction strategies or early detection of cancer, and identify family members at risk. The guidelines for evaluating patients who are candidates for genetic testing recommend pre-test genetic counseling. However, the limited number of specialists trained to provide genetic counseling worldwide, and particularly in developing countries such as Mexico, makes it difficult to implement such recommendations. The present proposal aims to compare, through a randomized non-inferiority study, a pre-test education strategy using a pre-recorded video against in-person counseling. This strategy could potentially increase access in places with limited resources. The general hypothesis of the research is that patients who are candidates for cancer genetic susceptibility testing who receive pre-test education via video will consent to genetic testing in the same proportion as those who receive it during an in-person visit. The specific objectives of the study include: 1) to compare the proportion of patients who are tested in both groups; 2) to assess knowledge about hereditary cancer in both groups after the intervention; 3) assess anxiety symptoms in both groups after the intervention; and 4) assess satisfaction with the information received during the intervention.Patients >18 years of age who meet the criteria for genetic testing to evaluate genetic cancer susceptibility genes and who have not previously undergone genetic testing or genetic counseling will be invited. The intervention group will receive education via pre-recorded video and the control group will receive genetic counseling during an in-person consultation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: January 3, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Meet cancer genetic testing criteria

Exclusion Criteria:

• Had a genetic testing before
• Had genetic counseling before

Related Conditions & MeSH terms

• Genetic Counseling
• Hereditary Cancer

Intervention

Behavioral:
• Educational Video
Pre-recorded educational video including hereditary cancer information, genetic cancer testing candidates, types of testing, type of results, benefits and risks, recommendations according to results, inheritance and common questions.
• In person genetic cancer counseling
Includes: Family history of cancer (3-generation family tree) Personal Cancer Risk Assessment Education on inheritance and expression of disease Types of tests Preparation on possible outcomes according to results Obtaining consent for test Opportunity to solve doubts

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic testing acceptance	Proportion of patients that accept to undergo a genetic testing	up to 12 weeks
Secondary	Genetic cancer knowledge change (pre and post intervention)	Knowgene questionnaire	up to 24 hours after intervention
Secondary	Anxiety level (pre and post intervention)	GAD-7 questionnaire	up to 24 hours after intervention