Hereditary CancerNCT06157801
Evaluation of Hereditary Cancer Educational Videos
An observational study of Hereditary Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if educational videos can help participants be more informed about hereditary cancers (ones that run in the family). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hereditary Cancer
- What is being tested?
- Interview Study and Survey Study
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2024to 31 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The Harris Health System (LBJ Hospital)
Who may be able to join
- Participants of The Harris Health System Lyndon B. Johnson (LBJ) Hospital outpatient oncology clinics (i.e., Gynecologic Oncology, Medical Oncology).
- 18 years of age or older.
- Speaks and/or reads English or Spanish.
- Has a pathogenic or likely pathogenic variant (mutation) in BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, and/or EPCAM on germline genetic testing.
- Has a documented genetic testing results disclosure encounter (i.e. telephone call, follow-up appointment).
Who cannot join
- No longer receives outpatient care at LBJ Hospital at time of recruitment.
- Has only a variant of uncertain significance in BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, and/or EPCAM.
- Has only a pathogenic or likely pathogenic variant in gene other than BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, or EPCAM.
- Is unwilling, unable, or requires a legally authorized representative to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
To learn if educational videos can help participants be more informed about hereditary cancers (ones that run in the family).
Read the detailed description
Primary Objective
Determine the impact of educational videos on:
- Participant's hereditary cancer knowledge.
- Participant's confidence to share hereditary cancer information with family members.
Secondary Objective
- Determine impact of educational videos on participant's confidence to undergo hereditary cancer screening.
- Identify opportunities to tailor and improve the educational video's content, style, and understandability per participant preferences and feedback.
- Conditions
- Hereditary Cancer
- Being tested
- Interview Study, Survey Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interview StudyBehavioural
All study participants will have the following demographic information collected from their medical records:
- Sex (Male/Female/Other)
- Date of birth
- Preferred language (English/Spanish)
- Health insurance status (for example: private insurance, HCHD "gold card")
- Cancer diagnosis (if yes: cancer type/organ, date of pathology diagnosis)
- Genetic testing result (gene with pathogenic/likely pathogenic variant)
- Date of genetic testing result
- Date of documented result disclosure.
Survey StudyBehavioural
All study participants will have the following demographic information collected from their medical records:
- Sex (Male/Female/Other)
- Date of birth
- Preferred language (English/Spanish)
- Health insurance status (for example: private insurance, HCHD "gold card")
- Cancer diagnosis (if yes: cancer type/organ, date of pathology diagnosis)
- Genetic testing result (gene with pathogenic/likely pathogenic variant)
- Date of genetic testing result
- Date of documented result disclosure.
| Study group | Role | What they receive |
|---|---|---|
| Interview Study | In the interview study, participants will watch the video, then complete an interview. This will take about 50 minutes. Receives: Behavioral: Interview Study | |
| Survey Study | In the survey study, participants will complete a survey about your education and complete a quick test about your knowledge of hereditary cancer. Participants will then watch the video. complete another survey similar to the one before the video. This should take about 30 minutes. Receives: Behavioral: Survey Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hereditary Cancer Multidimensional Measure of Informed Choice Questionnaires
Hereditary Cancer Multidimensional Measure of Informed Choice (MMIC)
Knowledge Score scale: (1-8) true or false
Measured: through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start5 Apr 2024
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Rauh-Hain, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157801
- Sponsor's protocol ID
- 2023-0654
- Other IDs
- NCI-2023-10074
- Status last verified
- Aug 2026
- First submitted
- 27 Nov 2023
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hereditary Cancer Educational Videos
- ClinicalTrials.gov ID
- NCT06157801
- Acronym / sponsor ID
- 2023-0654
- Conditions
- Hereditary Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 43 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 6 Dec 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.
To learn if educational videos can help participants be more informed about hereditary cancers (ones that run in the family).
Detailed description
Primary Objective
Determine the impact of educational videos on:
- Participant's hereditary cancer knowledge.
- Participant's confidence to share hereditary cancer information with family members.
Secondary Objective
- Determine impact of educational videos on participant's confidence to undergo hereditary cancer screening.
- Identify opportunities to tailor and improve the educational video's content, style, and understandability per participant preferences and feedback.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interview Study | – | Behavioral: Interview StudyIn the interview study, participants will watch the video, then complete an interview. This will take about 50 minutes. |
| Survey Study | – | Behavioral: Survey StudyIn the survey study, participants will complete a survey about your education and complete a quick test about your knowledge of hereditary cancer. Participants will then watch the video. complete another survey similar to the one before the video. This should take about 30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Harris Health System (LBJ Hospital)
Key inclusion criteria (5 listed)
- Participants of The Harris Health System Lyndon B. Johnson (LBJ) Hospital outpatient oncology clinics (i.e., Gynecologic Oncology, Medical Oncology).
- 18 years of age or older.
- Speaks and/or reads English or Spanish.
- Has a pathogenic or likely pathogenic variant (mutation) in BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, and/or EPCAM on germline genetic testing.
- Has a documented genetic testing results disclosure encounter (i.e. telephone call, follow-up appointment).
Key exclusion criteria (4 listed)
- No longer receives outpatient care at LBJ Hospital at time of recruitment.
- Has only a variant of uncertain significance in BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, and/or EPCAM.
- Has only a pathogenic or likely pathogenic variant in gene other than BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, or EPCAM.
- Is unwilling, unable, or requires a legally authorized representative to provide informed consent.
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 |
|---|---|---|
| Interview StudyAll study participants will have the following demographic information collected from their medical records: * Sex (Male/Female/Other) * Date of birth * Preferred language (English/Spanish) * Health insurance status (for example: private insurance, HCHD "gold card") * Cancer diagnosis (if yes: cancer type/organ, date of pathology diagnosis) * Genetic testing result (gene with pathogenic/likely pathogenic variant) * Date of genetic testing result * Date of documented result disclosure. | Behavioural | Interview Study |
| Survey StudyAll study participants will have the following demographic information collected from their medical records: * Sex (Male/Female/Other) * Date of birth * Preferred language (English/Spanish) * Health insurance status (for example: private insurance, HCHD "gold card") * Cancer diagnosis (if yes: cancer type/organ, date of pathology diagnosis) * Genetic testing result (gene with pathogenic/likely pathogenic variant) * Date of genetic testing result * Date of documented result disclosure. | Behavioural | Survey Study |
Primary outcome
Hereditary Cancer Multidimensional Measure of Informed Choice Questionnaires
Time frame: through study completion; an average of 1 year
Hereditary Cancer Multidimensional Measure of Informed Choice (MMIC) Knowledge Score scale: (1-8) true or false
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Jose Rauh-Hain, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hereditary Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Hereditary Cancer Multidimensional Measure of Informed Choice Questionnaires (time frame: through study completion; an average of 1 year). 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 14 Aug 2026.