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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality
• Intervention / Treatment: Other: Educational video and pamphlet; Other: Traditional genetic counseling

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Misha Rashkin; Phone Number: 650-724-5223; Email: mrashkin@stanfordhealthcare.org
• Study Contact Backup: Name: Meredith Mills; Phone Number: 650-724-5223; Email: bluett@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Recruiting
      • Stanford University
      • Contact: Misha Rashkin; Email: mrashkin@stanfordhealthcare.org
      • Sub-Investigator: Misha Rashkin
      • Sub-Investigator: Karlena Otero
      • Sub-Investigator: Courtney Teeter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: 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.; Other: Traditional genetic counseling; Patients will receive traditional genetic counseling
Experimental: 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	Other: 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.; Other: Traditional genetic counseling; Patients will receive traditional genetic counseling
Other: 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	Other: Traditional genetic counseling; Patients will receive traditional genetic counseling

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: James Ford, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2021
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: October 25, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: educational video; pamphlet; cancer genetic counseling
• Other Study ID Numbers: IRB-61374; VAR0214 (Other Identifier: OnCore); NCI-2022-00606 (Other Identifier: CTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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