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

Stanford University

Status: Completed

Conditions: Gastrointestinal Cancer; Gynecologic Cancer; Ovarian Cancer; Prostate Cancer; Quality; Pancreatic Cancer

Treatments: Other: Traditional genetic counseling; Other: Educational video and pamphlet

Study type: Interventional

Funder types: Other

Identifiers

NCT05132868

NCI-2022-00606 (Other Identifier)

IRB-61374

VAR0214 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Individuals who are minors
• Individuals who are decisionally impaired

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 3 patient groups

pre-educated with educational video

Experimental group

Description:

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

Treatment:

Other: Traditional genetic counseling

Other: Educational video and pamphlet

pre-educated with pamphlet

Experimental group

Description:

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

Treatment:

Other: Traditional genetic counseling

Other: Educational video and pamphlet

educated during the session

Other group

Description:

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

Treatment:

Other: Traditional genetic counseling