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OpenTrials
Completed

NCT Number: NCT05132868

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational video and pamphlet

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

Other

Patients will receive traditional genetic counseling

Primary outcomes

  1. Patient impact with educational information prior to genetic counseling

    Time frame: 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

    Time frame: 36 months

    Impact will be defined as the number of questions asked by patient during the counseling.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 24, 2021
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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