Assessments Of Genetic Counseling Augmented With An Educational Video Or Pamphlet Versus Traditional Counseling

Study Overview

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.

N/A

Quality
Prostate Cancer
Gastrointestinal Cancer
Gynecologic Cancer
Ovarian Cancer
Pancreatic Cancer

OTHER: Educational video and pamphlet
OTHER: Traditional genetic counseling

IRB-61374
VAR0214 (OTHER Identifier) (OTHER: OnCore)
NCI-2022-00606 (OTHER Identifier) (OTHER: CTRP)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-10-25	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-08-07
First Submitted that Met QC Criteria 2021-11-12	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-08-09
First Posted (ACTUAL) 2021-11-24	Results First Posted N/A	Last Verified 2024-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

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 c	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 c	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 geneti	OTHER: Traditional genetic counseling Patients will receive traditional genetic counseling

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 c

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 c

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 geneti

OTHER: Traditional genetic counseling

Patients will receive traditional genetic counseling

Primary Outcome Measures	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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Individuals who are minors
Individuals who are decisionally impaired

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: James Ford, MD, Stanford University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record