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Outreach and Reminder Strategies for Colorectal Cancer Screening
N/A
Waitlist Available
Led By Shivan Mehta, MD
Research Sponsored by Abramson Cancer Center at Penn Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial assesses the effectiveness of a centralized program to increase colorectal cancer screening among average-risk patients. Outreach, EHR nudges, & text reminders are used to track completion rates over 3 years.
Who is the study for?
This trial is for patients aged 50-72 who are overdue for colorectal cancer screening, have seen a participating primary care physician in the last two years, and aren't up to date with their screenings. It's not for those on hospice or palliative care, uninsured/self-pay individuals, scheduled for colon procedures, at high risk of dying within three years, or with certain gastrointestinal conditions.Check my eligibility
What is being tested?
The study tests if direct patient outreach programs and clinician nudges via electronic health records plus follow-up texts increase colorectal cancer screening rates over three years. Patients will be randomly assigned to receive different types of reminders or no reminder about CRC screening.See study design
What are the potential side effects?
Since this trial focuses on communication strategies rather than medical treatments, there are no direct side effects from interventions like drugs or surgeries. However, participants may experience anxiety or stress related to undergoing CRC screenings.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CRC screening completion at 3 years
Secondary outcome measures
CRC screening rate
Choice of test
Trial Design
5Treatment groups
Experimental Treatment
Group I: Arm 3B: Sequential Choice and Visit-Based Nudge/TextExperimental Treatment2 Interventions
Using bulk ordering, patients assigned to this arm will receive an order for colonoscopy and direct outreach (via text message and either the electronic patient portal or mailed letter, depending on their patient portal status) informing them they are overdue for CRC screening. If not completed, patients will receive an order and a mailed fecal immunochemical test (FIT) with a reminder to complete CRC screening. Patients randomized to this arm who attend a visit with their Primary Care Physician (PCP) will additionally receive a visit-based, clinician directed nudge to discuss colorectal cancer screening and a follow-up text 3 days post-visit to encourage screening completion.
Group II: Arm 3A: Sequential Choice and No Nudge/TextExperimental Treatment2 Interventions
Using bulk ordering, patients assigned to this arm will receive an order for colonoscopy and direct outreach (via text message and either the electronic patient portal or mailed letter, depending on their patient portal status) informing them they are overdue for CRC screening. If not completed, patients will receive an order and a mailed fecal immunochemical test (FIT) with a reminder to complete CRC screening. Patients randomized to this arm will not receive visit-based interventions.
Group III: Arm 2B: Colonoscopy Only and Visit-Based Nudge/TextExperimental Treatment2 Interventions
Using bulk ordering, patients assigned to this arm will receive an order for colonoscopy and direct outreach (via text message and either the electronic patient portal or mailed letter, depending on their patient portal status) informing them they are overdue for CRC screening. Patients randomized to this arm who attend a visit with their Primary Care Physician (PCP) will additionally receive a visit-based, clinician directed nudge to discuss colorectal cancer screening and a follow-up text 3 days post-visit to encourage screening completion.
Group IV: Arm 2A: Colonoscopy Only and No Nudge/TextExperimental Treatment2 Interventions
Using bulk ordering, patients assigned to this arm will receive an order for colonoscopy and direct outreach (via text message and either the electronic patient portal or mailed letter, depending on their patient portal status) informing them they are overdue for CRC screening. Patients randomized to this arm will not receive visit-based interventions.
Group V: Arm 1A: Usual CareExperimental Treatment2 Interventions
Patients assigned to the Usual Care arm will receive current usual care and will not receive direct patient outreach or any visit-based interventions from this trial.
Find a Location
Who is running the clinical trial?
Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
125,695 Total Patients Enrolled
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
85,095 Total Patients Enrolled
Shivan Mehta, MDPrincipal InvestigatorUniversity of Pennsylvania
15 Previous Clinical Trials
57,667 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had my entire colon removed, have dementia, or cancer that has spread.I have an active order for a stool DNA test.I have a history of being unable to move my legs or all four limbs.I have had a FIT test ordered within the last 60 days.I am between 50 and 72 years old.I am not current with my colorectal cancer screenings.I or my family have a history of colorectal cancer or related conditions.I am scheduled for a colonoscopy or sigmoidoscopy.I am currently receiving end-of-life care.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2B: Colonoscopy Only and Visit-Based Nudge/Text
- Group 2: Arm 3A: Sequential Choice and No Nudge/Text
- Group 3: Arm 1A: Usual Care
- Group 4: Arm 3B: Sequential Choice and Visit-Based Nudge/Text
- Group 5: Arm 2A: Colonoscopy Only and No Nudge/Text
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants of this trial required to be older than twenty years?
"This trial is open to adults aged 50-72, with 35 trials specifically for individuals younger than 18 and 1037 studies available to those above 65."
Answered by AI
Are there any unfilled vacancies in this clinical trial?
"According to the information on clinicaltrials.gov, this trial is currently not recruiting any new participants. Initially posted in February of 2023 and last updated in January of that same year, it appears that no more patients are being sought out at this time. However, there are 1051 other trials actively seeking volunteers right now."
Answered by AI
What qualifications must an individual fulfill to become a participant in this clinical trial?
"This research trial is open to 20,000 participants with colorectal cancer between the ages of 50 and 72. Criteria for eligibility include: age range, being followed by a listed Penn Medicine primary care physician within the last two years, and not having received any colonoscopy screenings in the past decade as well as stool tests or flexible sigmoidoscopies in the prior 5-3 years respectively."
Answered by AI
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