Evaluation of Hereditary Cancer Educational Videos

Hereditary Cancer Clinical Trial

Official title:

Evaluation of Hereditary Cancer Educational Videos

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06157801
• Other study ID #: 2023-0654
• Secondary ID: NCI-2023-10074
• Status: Recruiting
• Start date: April 5, 2024
• Est. completion date: October 31, 2024

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: Jose Rauh-Hain, MD
• Phone: (713) 794-1759
• Email: jarauh[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To learn if educational videos can help participants be more informed about hereditary cancers (ones that run in the family).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Participants of The Harris Health System Lyndon B. Johnson (LBJ) Hospital outpatient oncology clinics (i.e., Gynecologic Oncology, Medical Oncology).

2. 18 years of age or older.

3. Speaks and/or reads English or Spanish.

4. Has a pathogenic or likely pathogenic variant (mutation) in BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, and/or EPCAM on germline genetic testing.

5. Has a documented genetic testing results disclosure encounter (i.e. telephone call, follow-up appointment).

Exclusion Criteria:

1. No longer receives outpatient care at LBJ Hospital at time of recruitment.

2. Has only a variant of uncertain significance in BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, and/or EPCAM.

3. Has only a pathogenic or likely pathogenic variant in gene other than BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, or EPCAM.

4. Is unwilling, unable, or requires a legally authorized representative to provide informed consent.

Related Conditions & MeSH terms

• Hereditary Cancer

Intervention

Behavioral:
• Interview Study
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 Study
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.

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hereditary Cancer Multidimensional Measure of Informed Choice Questionnaires	Hereditary Cancer Multidimensional Measure of Informed Choice (MMIC); Knowledge Score scale: (1-8) true or false	through study completion; an average of 1 year

External Links

•   MD Anderson Cancer Center