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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06157801
Other study ID # 2023-0654
Secondary ID NCI-2023-10074
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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