NCT05805982

Educational Video Versus In-person Genetic Counseling for Hereditary Cancer

Completed NA Last updated 10 April 2023

What this trial tests

NA trial testing Educational Video in Genetic Counseling in 251 participants. Completed in 3 January 2023.

Timeline

10 August 2020

Primary endpoint
30 November 2022

3 January 2023

Quick facts

Lead sponsor	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	251
Start date	10 August 2020
Primary completion	30 November 2022
Estimated completion	3 January 2023
Sites	1 location across Mexico

Drugs / interventions tested

• Educational Video
• In person genetic cancer counseling

Conditions studied

• Genetic Counseling — all drugs for Genetic Counseling →
• Hereditary Cancer — all drugs for Hereditary Cancer →

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran — full company profile →

Who can join

18 and older, any sex, with Genetic Counseling or Hereditary Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.