Clinical trial NCT05132868: Assessments of Genetic Counseling Augmented With an Educational Video or Pamphlet Versus Traditional Counseling
Official title: Assessments of Genetic Counseling Augmented With an Educational Video or Pamphlet Versus Traditional Counseling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality
Prostate Cancer
Gastrointestinal Cancer
Gynecologic Cancer
Ovarian Cancer
Pancreatic Cancer
Keywords: cancer genetic counseling
educational video
pamphlet
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient impact with educational information prior to genetic counseling
timeFrame: 36 months
measure: Patient impact without any educational information prior to genetic counseling
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: James Ford, MD
role: PRINCIPAL_INVESTIGATOR
References: