Educational Video Versus In-person Genetic Counseling for Hereditary Cancer

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status: Completed

Conditions: Genetic Counseling; Hereditary Cancer

Treatments: Behavioral: In person genetic cancer counseling; Behavioral: Educational Video

Study type: Interventional

Funder types: Other

Identifiers

NCT05805982

HEM-3442

Details and patient eligibility

About

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.

Enrollment: 251 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meet cancer genetic testing criteria

Exclusion criteria

• Had a genetic testing before
• Had genetic counseling before

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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251 participants in 2 patient groups

Educational Video

Experimental group

Description:

The patient will watch a 15-minute video on an electronic tablet that includes the following items: * What is hereditary cancer? * Inheritance risk * Who are candidates for a genetic test? * What is a genetic testing and how can it help? * What types of results can be expected from genetic testing? * Reactions to the result of the genetic test * Clinical care according to the results * Any common questions? When the patient finish watching the video, he/she would have the opportunity to resolve any doubts.

Treatment:

Behavioral: Educational Video

In-Person genetic counseling

Active Comparator group

Description:

Patients will receive pre-test genetic counseling in person with a specialist using the usual protocols existing at the Institute and systematically includes the following: Family history of cancer Personal cancer risk assessment Education on inheritance and disease expression Types of tests and results (positive, negative and variants of uncertain significance). Limitations of the genetic study Preparation of possible outcomes according to results Risks Additional information: confidentiality of the results, costs and test options. Opportunity will be given to resolve doubts

Treatment:

Behavioral: In person genetic cancer counseling