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

NCT ID: NCT05132868

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-25
• Study Completion Date: 2023-06-28

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

pre-educated with educational video

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

Group Type: EXPERIMENTAL

Educational video and pamphlet

Intervention Type: OTHER

The primary intervention in this study is watching the video or reading the pamphlet in advance of the genetic counseling session, which overview the same information that we currently provide in-person/via telehealth during the genetic counseling session.

Traditional genetic counseling

Intervention Type: OTHER

Patients will receive traditional genetic counseling

pre-educated with 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

Group Type: EXPERIMENTAL

Educational video and pamphlet

Intervention Type: OTHER

The primary intervention in this study is watching the video or reading the pamphlet in advance of the genetic counseling session, which overview the same information that we currently provide in-person/via telehealth during the genetic counseling session.

Traditional genetic counseling

Intervention Type: OTHER

Patients will receive traditional genetic counseling

educated during the session

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

Group Type: OTHER

Traditional genetic counseling

Intervention Type: OTHER

Patients will receive traditional genetic counseling

Interventions

Educational video and pamphlet

The primary intervention in this study is watching the video or reading the pamphlet in advance of the genetic counseling session, which overview the same information that we currently provide in-person/via telehealth during the genetic counseling session.

Intervention Type: OTHER

Traditional genetic counseling

Patients will receive traditional genetic counseling

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

James Ford

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Ford, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Countries

United States

Other Identifiers

VAR0214

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2022-00606

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-61374

Identifier Type: -

Identifier Source: org_study_id