Educational Video Versus In-person Genetic Counseling for Hereditary Cancer

NCT05805982 | Completed

• 1 other identifier: HEM-3442
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Genetic testing acceptance

  Proportion of patients that accept to undergo a genetic testing

  up to 12 weeks

Secondary Outcomes (2)

• Genetic cancer knowledge change (pre and post intervention)

  up to 24 hours after intervention

• Anxiety level (pre and post intervention)

  up to 24 hours after intervention

Study Arms (2)

Educational Video

EXPERIMENTAL

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.

Behavioral: Educational Video

In-Person genetic counseling

ACTIVE COMPARATOR

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

Behavioral: In person genetic cancer counseling

Interventions

Educational Video 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.

Educational Video

In person genetic cancer counseling 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

In-Person genetic counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet cancer genetic testing criteria

You may not qualify if:

• Had a genetic testing before
• Had genetic counseling before

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, Mexico

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: April 10, 2023
• Study Start: August 10, 2020
• Primary Completion: November 30, 2022
• Study Completion: January 3, 2023
• Last Updated: April 10, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)