Default Genetics Referrals for Young-Onset Colorectal Cancer

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Behavioral: Default Genetics Referral Process

• Registration Number: NCT05018156
• Lead Sponsor: University of Pennsylvania

Brief Summary

The investigators will perform a pilot implementation study of a default genetics referral process among patients with young-onset CRC diagnosed between ages 40 and 49.

Detailed Description

The incidence of young-onset colorectal cancer (CRC) - defined as a diagnosis of CRC prior to age 50 - has increased at alarming rates in recent years. Over 75% of cases occur in patients diagnosed between 40-49 years old, a group that is not traditionally included in young adult cancer initiatives tailored only to patients up to 39 years of age. Young age of CRC onset is a defining feature of hereditary CRC syndromes; as such, the National Comprehensive Cancer Network and American College of Medical Genetics and Genomics recommend germline genetics evaluations for all patients diagnosed with CRC under the age of 50. However, multiple studies have shown suboptimal rates and racial and socioeconomic disparities in guideline-recommended genetics evaluations.

In this pilot implementation study, the investigators aim to develop, implement, and evaluate the effects of a default genetics referral process among patients with young-onset CRC diagnosed between 40-49 years old. The investigators hypothesize that by applying defaults, or pre-selected choices, to minimize the cognitive effort that patients and clinicians use to make decisions, default referrals will improve rates of genetics referrals while reducing existing racial and socioeconomic disparities. The investigators will implement this intervention at five academic and community hospitals within Penn Medicine that serve a racially, socioeconomically, and geographically diverse patient population. The investigators will use an automated electronic health record-based algorithm to identify eligible patients, after which default referrals for genetic risk evaluation will be made unless patients or their oncology clinicians opt out. The investigators will rigorously evaluate the impact of this default genetics referral process using mixed methods leveraging models and frameworks from the field of implementation science.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2021-08-06
• Study First Submitted QC: 2021-08-18
• Study First Posted: 2021-08-24
• Study Start: 2021-11-10
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-15
• Last Update Posted: 2022-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Newly diagnosed with colon or rectal adenocarcinoma
• Between 40-49 years old at the time of index cancer diagnosis
• At least two visits at Penn Medicine for the evaluation or treatment of the index cancer

Read More

Exclusion Criteria

• Diagnosis of in situ cancer
• Known genetic predisposition to cancer
• Genetic testing after index cancer diagnosis

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Default Genetics Referral Process	Default Genetics Referral Process	-

Primary Outcome Measures

Name	Time	Method
Genetics referrals	3 months	The number of patients who are ultimately referred to genetics divided by the total number of eligible patients

Secondary Outcome Measures

Name	Time	Method
Completed genetics evaluations	3 months	The proportion of genetics evaluations that are completed divided by the total number of scheduled genetics evaluations
Scheduled genetics evaluations	3 months	The proportion of genetics evaluations that are scheduled divided by the total number of genetics referrals
Genetic testing	3 months	The proportion of genetics evaluations that result in genetic testing divided by the total number of completed genetics evaluations

Trial Locations

Locations (1)

Penn Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States