Default Genetics Referrals for Young-Onset Colorectal Cancer

NCT ID: NCT05018156

Last Updated: 2022-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-10
• Study Completion Date: 2022-08-31

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Default Genetics Referral Process

Group Type: EXPERIMENTAL

Default Genetics Referral Process

Intervention Type: BEHAVIORAL

Patients and their oncology providers will be notified of their eligibility for a cancer genetics referral, with an option to opt out if they are not interested in proceeding. Everyone else will be automatically referred to their local hospital's cancer genetics program for contact and scheduling. Standard genetic counseling, testing, and results disclosure will take place, including usual methods of payment and insurance coverage for testing.

Interventions

Default Genetics Referral Process

Patients and their oncology providers will be notified of their eligibility for a cancer genetics referral, with an option to opt out if they are not interested in proceeding. Everyone else will be automatically referred to their local hospital's cancer genetics program for contact and scheduling. Standard genetic counseling, testing, and results disclosure will take place, including usual methods of payment and insurance coverage for testing.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Kelsey Lau-Min, MD

Hematology/Oncology Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Penn Medicine

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

849320

Identifier Type: -

Identifier Source: org_study_id