Educational Video Versus In-person Genetic Counseling for Hereditary Cancer

Not Applicable

Completed

• Conditions: Genetic Counseling; Hereditary Cancer

• Registration Number: NCT05805982
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-10
• Primary Completion: 2022-11-30
• Study Completion: 2023-01-03
• Study First Submitted: 2023-02-07
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-06
• Last Update Submitted: 2023-04-06
• Study First Posted: 2023-04-10
• Last Update Posted: 2023-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

Inclusion Criteria

• Meet cancer genetic testing criteria

Exclusion Criteria

• Had a genetic testing before
• Had genetic counseling before

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Genetic testing acceptance	up to 12 weeks	Proportion of patients that accept to undergo a genetic testing

Secondary Outcome Measures

Name	Time	Method
Genetic cancer knowledge change (pre and post intervention)	up to 24 hours after intervention	Knowgene questionnaire
Anxiety level (pre and post intervention)	up to 24 hours after intervention	GAD-7 questionnaire

Trial Locations

Locations (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán; 🇲🇽 Mexico City, Mexico