search
Back to results

Default Genetics Referrals for Young-Onset Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Default Genetics Referral Process
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colorectal Cancer

Eligibility Criteria

40 Years - 49 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Penn Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Default Genetics Referral Process

Arm Description

Outcomes

Primary Outcome Measures

Genetics referrals
The number of patients who are ultimately referred to genetics divided by the total number of eligible patients

Secondary Outcome Measures

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

Full Information

First Posted
August 6, 2021
Last Updated
December 15, 2022
Sponsor
University of Pennsylvania
search

1. Study Identification

Unique Protocol Identification Number
NCT05018156
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
November 10, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Default Genetics Referral Process
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Default Genetics Referral Process
Intervention Description
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.
Primary Outcome Measure Information:
Title
Genetics referrals
Description
The number of patients who are ultimately referred to genetics divided by the total number of eligible patients
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Scheduled genetics evaluations
Description
The proportion of genetics evaluations that are scheduled divided by the total number of genetics referrals
Time Frame
3 months
Title
Completed genetics evaluations
Description
The proportion of genetics evaluations that are completed divided by the total number of scheduled genetics evaluations
Time Frame
3 months
Title
Genetic testing
Description
The proportion of genetics evaluations that result in genetic testing divided by the total number of completed genetics evaluations
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Penn Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Default Genetics Referrals for Young-Onset Colorectal Cancer

We'll reach out to this number within 24 hrs