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

Sponsor
Stanford University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05132868
Collaborator
(none)
200
1
3
31.2
6.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Educational video and pamphlet
  • Other: Traditional genetic counseling
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Assessments of Genetic Counseling Augmented With an Educational Video or Pamphlet Versus Traditional Counseling
Actual Study Start Date :
Aug 25, 2021
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University Palo Alto California United States 94305

Sponsors and Collaborators

  • Stanford University

Investigators

  • Principal Investigator: James Ford, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stanford University
ClinicalTrials.gov Identifier:
NCT05132868
Other Study ID Numbers:
  • 61374
  • VAR0214
First Posted:
Nov 24, 2021
Last Update Posted:
Nov 24, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Stanford University

Study Results

No Results Posted as of Nov 24, 2021