Evaluation of Hereditary Cancer Educational Videos

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

Study Overview

• Status: Recruiting
• Conditions: Hereditary Cancer
• Intervention / Treatment: Behavioral: Interview Study; Behavioral: Survey Study

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 Type: Observational
• Enrollment (Estimated): 74

Contacts and Locations

• Study Contact: Name: Jose Rauh-Hain, MD; Phone Number: (713) 794-1759; Email: jarauh@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
      • Contact: Jose Rauh-Hain, MD; Phone Number: 713-794-1759; Email: jarauh@mdanderson.org
      • Principal Investigator: Jose Rauh-Hain, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The Harris Health System (LBJ Hospital)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Interview Study; In the interview study, participants will watch the video, then complete an interview. This will take about 50 minutes.	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; 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Jose Rauh-Hain, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2024
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2023-0654; NCI-2023-10074 (Other Identifier: NCI-CTRP Clinical Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No