Genetic CounselingNCT05805982
Educational Video Versus In-person Genetic Counseling for Hereditary Cancer
A study testing Educational Video and In person genetic cancer counseling in people with Genetic Counseling and Hereditary Cancer, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Genetic Counseling, Hereditary Cancer
- What is being tested?
- Educational Video and In person genetic cancer counseling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 1 siteMexico
- Study dates
- 10 Aug 2020to 3 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet cancer genetic testing criteria
Who cannot join
- Had a genetic testing before
- Had genetic counseling before
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City
About this study
Official title: Randomized Non Inferiority Trial of Educational Video Versus In-person Genetic Counseling for Hereditary Cancer
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
- Being tested
- Educational Video, In person genetic cancer counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational VideoBehavioural
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 cancer counselingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: In person genetic cancer counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic testing acceptance
Proportion of patients that accept to undergo a genetic testing
Measured: up to 12 weeks
Secondary outcomes (2)
Genetic cancer knowledge change (pre and post intervention)
Knowgene questionnaire
Measured: up to 24 hours after intervention
Anxiety level (pre and post intervention)
GAD-7 questionnaire
Measured: up to 24 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start10 Aug 2020
- Primary completion30 Nov 2022
- Study completion3 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic CounselingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanin Chavarri Guerra, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805982
- Sponsor's protocol ID
- HEM-3442
- Status last verified
- Apr 2023
- First submitted
- 7 Feb 2023
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Non Inferiority Trial of Educational Video Versus In-person Genetic Counseling for Hereditary Cancer
- ClinicalTrials.gov ID
- NCT05805982
- Acronym / sponsor ID
- HEM-3442
- Conditions
- Genetic Counseling, Hereditary Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Video | Experimental | Behavioral: Educational VideoThe 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. |
| In-Person genetic counseling | Active comparator | Behavioral: In person genetic cancer counselingPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Meet cancer genetic testing criteria
Key exclusion criteria (2 listed)
- Had a genetic testing before
- Had genetic counseling before
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational VideoPre-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. | Behavioural | Educational Video |
| In person genetic cancer counselingIncludes: 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 | Behavioural | In-Person genetic counseling |
Primary outcome
Genetic testing acceptance
Time frame: up to 12 weeks
Proportion of patients that accept to undergo a genetic testing
2 secondary outcomes
Genetic cancer knowledge change (pre and post intervention)
Time frame: up to 24 hours after intervention
Anxiety level (pre and post intervention)
Time frame: up to 24 hours after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Video and In person genetic cancer counseling in people with Genetic Counseling and Hereditary Cancer, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic testing acceptance (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.