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

NCT05132868 | Completed

• 3 other identifiers: IRB-61374VAR0214NCI-2022-00606
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality; Prostate Cancer; Gastrointestinal Cancer; Gynecologic Cancer; Ovarian Cancer; Pancreatic Cancer

Keywords

cancer genetic counseling; educational video; pamphlet

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

pre-educated with educational video

EXPERIMENTAL

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; Other: Traditional genetic counseling

pre-educated with pamphlet

EXPERIMENTAL

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; Other: Traditional genetic counseling

educated during the session

OTHER

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

Interventions

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.

pre-educated with educational video; pre-educated with pamphlet

Traditional genetic counseling OTHER

Patients will receive traditional genetic counseling

educated during the session; pre-educated with educational video; pre-educated with pamphlet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Individuals who are minors
• Individuals who are decisionally impaired

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Gastrointestinal Neoplasms; Ovarian Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Neoplasms, Female; Endocrine System Diseases; Gonadal Disorders; Pancreatic Diseases

Study Officials

• James Ford, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 24, 2021
• Study Start: May 25, 2021
• Primary Completion: June 28, 2023
• Study Completion: June 28, 2023
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

US (1)