Clinical trial NCT05018156: Default Genetics Referrals for Young-Onset Colorectal Cancer
Official title: Pilot Implementation Study of a Default Genetics Referral Process for Patients With Young-Onset Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 53
Sex: ALL
Minimum age (years): 40
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Genetics referrals
timeFrame: 3 months
Secondary outcomes:
measure: Scheduled genetics evaluations
timeFrame: 3 months
measure: Completed genetics evaluations
timeFrame: 3 months
measure: Genetic testing
timeFrame: 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Medicine
state: Pennsylvania
Study officials:
References: