Educational Video Versus In-person Genetic Counseling for Hereditary Cancer

NCT ID: NCT05805982

Last Updated: 2023-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 251 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-10
• Study Completion Date: 2023-01-03

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.

Conditions

Genetic Counseling; Hereditary Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Educational Video

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.

Group Type: EXPERIMENTAL

Educational Video

Intervention Type: BEHAVIORAL

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 counseling

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

Group Type: ACTIVE_COMPARATOR

In person genetic cancer counseling

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Meet cancer genetic testing criteria

Exclusion Criteria

• Had a genetic testing before
• Had genetic counseling before

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

OTHER

Sponsor Role: lead

Responsible Party

Yanin Chavarri Guerra

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, , Mexico

Countries

Mexico

Other Identifiers

HEM-3442

Identifier Type: -

Identifier Source: org_study_id