Default Genetics Referrals for Young-Onset Colorectal Cancer
Pilot Implementation Study of a Default Genetics Referral Process for Patients With Young-Onset Colorectal Cancer
1 other identifier
interventional
53
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable colorectal-cancer
Started Nov 2021
Shorter than P25 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2021
CompletedFirst Posted
Study publicly available on registry
August 24, 2021
CompletedStudy Start
First participant enrolled
November 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedDecember 19, 2022
December 1, 2022
10 months
August 6, 2021
December 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Genetics referrals
The number of patients who are ultimately referred to genetics divided by the total number of eligible patients
3 months
Secondary Outcomes (3)
Scheduled genetics evaluations
3 months
Completed genetics evaluations
3 months
Genetic testing
3 months
Study Arms (1)
Default Genetics Referral Process
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Diagnosis of in situ cancer
- Known genetic predisposition to cancer
- Genetic testing after index cancer diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Penn Medicine
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Hematology/Oncology Fellow
Study Record Dates
First Submitted
August 6, 2021
First Posted
August 24, 2021
Study Start
November 10, 2021
Primary Completion
August 31, 2022
Study Completion
August 31, 2022
Last Updated
December 19, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share