Assessments of Genetic Counseling Augmented With an Educational Video or Pamphlet Versus Traditional Counseling

Not Applicable

Completed

• Conditions: Prostate Cancer; Ovarian Cancer; Pancreatic Cancer; Quality; Gynecologic Cancer; Gastrointestinal Cancer
• Interventions: Other: Educational video and pamphlet; Other: Traditional genetic counseling

• Registration Number: NCT05132868
• Lead Sponsor: Stanford University

Brief Summary

The purpose of this research study is to understand the impact of an educational video or pamphlet on the patient experience in a hereditary cancer genetic counseling program. In order to make this assessment, it is necessary to perform qualitative and quantitative research among patients in a hereditary cancer genetic counseling clinic.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-05-25
• Study First Submitted: 2021-10-25
• Study First Submitted QC: 2021-11-12
• Study First Posted: 2021-11-24
• Primary Completion: 2023-06-28
• Study Completion: 2023-06-28
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Inclusion criteria for: Limited English Proficiency (LEP), primarily Spanish speaking cohort

• Preferred language for receiving medical information is Spanish
• Has a personal or family history of cancer
• If assigned to the arm where they need to be pre-educated with a video or pamphlet, attests that they viewed the video or pamphlet

Inclusion criteria for: Individuals with a personal or family history of breast cancer cohort

• Personal or family history of breast cancer
• English is preferred language
• If assigned to the arm where they need to be pre-educated with a video or pamphlet, attests that they viewed the video or pamphlet

Inclusion criteria for: Individuals with a personal or family history of prostate cancer cohort

• Personal or family history of prostate cancer
• English is preferred language
• If assigned to the arm where they need to be pre-educated with a video or pamphlet, attests that they viewed the video or pamphlet

Inclusion criteria for: Individuals with a personal or family history of any type of cancer referred for germline testing based on a genetic variant identified during tumor genomic analysis for the patient or affected family member cohort.

• Personal or family history of any type of cancer
• Referred based on a variant identified during tumor genomic analysis
• English is preferred language
• If assigned to the arm where they need to be pre-educated with a video or pamphlet, attests that they viewed the video or pamphlet

Inclusion criteria for: Individuals with a personal or family history of gastrointestinal or gynecologic cancer, referred because they or their affected relative screened positive for Lynch Syndrome based on either an immunohistochemistry test or evidence of mismatch repair deficiency in their tumor cohort.

• Personal or family history of gastrointestinal or gynecologic cancer
• Screened positive for Lynch Syndrome based on IHC or MMR testing
• English is preferred language
• If assigned to the arm where they need to be pre-educated with a video or pamphlet, attests that they viewed the video or pamphlet

Inclusion criteria for: Individuals with a personal or family history of ovarian and/or pancreatic cancer cohort

• Personal or family history of ovarian, and/or pancreatic cancer
• English is preferred language
• If assigned to the arm where they need to be pre-educated with a video or pamphlet, attests that they viewed the video or pamphlet

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Exclusion Criteria

• Individuals who are minors
• Individuals who are decisionally impaired

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pre-educated with educational video	Traditional genetic counseling	Participants will receive a message to view educational videos prior to their genetic counseling appointment if they are assigned to a pre-educated arm. The video will be shared with patients via MyHealth in the "education" tab in advance of the genetic counseling session
educated during the session	Traditional genetic counseling	Participants will receive traditional genetic counseling. . After the genetic counseling session, they will fill out a validated survey called the Multi-dimensional Measure of Informed Choice (MMIC) that assesses attitudes, knowledge, and uptake of genetic testing
pre-educated with pamphlet	Educational video and pamphlet	Participants will receive a message to view a pamphlet prior to their genetic counseling appointment if they are assigned to a pre-educated arm. The pamphlet will be sent to patients who cannot access the video via regular mail in advance of the genetic counseling session
pre-educated with pamphlet	Traditional genetic counseling	Participants will receive a message to view a pamphlet prior to their genetic counseling appointment if they are assigned to a pre-educated arm. The pamphlet will be sent to patients who cannot access the video via regular mail in advance of the genetic counseling session
pre-educated with educational video	Educational video and pamphlet	Participants will receive a message to view educational videos prior to their genetic counseling appointment if they are assigned to a pre-educated arm. The video will be shared with patients via MyHealth in the "education" tab in advance of the genetic counseling session

Primary Outcome Measures

Name	Time	Method
Patient impact with educational information prior to genetic counseling	36 months	Impact will be defined as the number of questions asked by patient during the counseling.
Patient impact without any educational information prior to genetic counseling	36 months	Impact will be defined as the number of questions asked by patient during the counseling.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States