Colorectal CancerNCT05018156
Default Genetics Referrals for Young-Onset Colorectal Cancer
A study testing Default Genetics Referral Process in people with Colorectal Cancer, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 49 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Default Genetics Referral Process
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2021to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Diagnosis of in situ cancer
- Known genetic predisposition to cancer
- Genetic testing after index cancer diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Implementation Study of a Default Genetics Referral Process for Patients With Young-Onset Colorectal Cancer
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.
Read the 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
- Being tested
- Default Genetics Referral Process
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Default Genetics Referral ProcessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Default Genetics Referral Process | Experimental | Not described Receives: Behavioral: Default Genetics Referral Process |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetics referrals
The number of patients who are ultimately referred to genetics divided by the total number of eligible patients
Measured: 3 months
Secondary outcomes (3)
Scheduled genetics evaluations
The proportion of genetics evaluations that are scheduled divided by the total number of genetics referrals
Measured: 3 months
Completed genetics evaluations
The proportion of genetics evaluations that are completed divided by the total number of scheduled genetics evaluations
Measured: 3 months
Genetic testing
The proportion of genetics evaluations that result in genetic testing divided by the total number of completed genetics evaluations
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start10 Nov 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelsey Lau-Min, MD, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018156
- Sponsor's protocol ID
- 849320
- Status last verified
- Dec 2022
- First submitted
- 6 Aug 2021
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Implementation Study of a Default Genetics Referral Process for Patients With Young-Onset Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05018156
- Acronym / sponsor ID
- 849320
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Default Genetics Referral Process | Experimental | Behavioral: Default Genetics Referral Process |
Who may qualify
- Ages
- 40 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Diagnosis of in situ cancer
- Known genetic predisposition to cancer
- Genetic testing after index cancer diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Default Genetics Referral ProcessPatients 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. | Behavioural | Default Genetics Referral Process |
Primary outcome
Genetics referrals
Time frame: 3 months
The number of patients who are ultimately referred to genetics divided by the total number of eligible patients
3 secondary outcomes
Scheduled genetics evaluations
Time frame: 3 months
Completed genetics evaluations
Time frame: 3 months
Genetic testing
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Default Genetics Referral Process in people with Colorectal Cancer, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetics referrals (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2022.