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

Quality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05132868
• Other study ID #: IRB-61374
• Secondary ID: VAR0214NCI-2022-
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2021
• Est. completion date: April 2024

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: Misha Rashkin
• Phone: 650-724-5223
• Email: mrashkin[@]stanfordhealthcare.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Quality

Intervention

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.
• Traditional genetic counseling
Patients will receive traditional genetic counseling

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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