Colorectal CancerNCT05693649
Behavioral Economic Approaches for Population-Based Colorectal Cancer Screening
A study testing No Direct Patient Outreach, Direct Patient Outreach: Colonoscopy Only and Direct Patient Outreach: Sequential Choice in people with Colorectal Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
This is a 3-year pragmatic, randomized clinical trial among average-risk patients at diverse primary care practices who are overdue for colorectal (CRC) screening. This project aims to evaluate the effect of a centralized program that includes direct outreach to patients and visit-based, clinician directed nudges… Read more about this study
- Who is it for?
- Ages 50 to 72 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- No Direct Patient Outreach, Direct Patient Outreach: Colonoscopy Only and Direct Patient Outreach: Sequential Choice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2023to 21 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ages 50-72
- Followed by Primary Care with a participating Penn Medicine PCP listed and at least one visit in the last 2 years
- Not up to date on colorectal cancer screening per Health Maintenance (no colonoscopy in the last 10 years, stool testing in the last year, flexible sigmoidoscopy in the last 5 years, MT-sDNA in the last 3 years).
Who cannot join
- Personal or significant family history of CRC, colonic polyps, hereditary nonpolyposis colorectal cancer syndrome, familial adenomatous polyposis syndrome, other gastrointestinal cancer, gastrointestinal bleeding, iron-deficiency anemia, or inflammatory bowel disease
- History of total colectomy, dementia or metastatic cancer
- Currently on hospice or receiving palliative care
- Uninsured or self-pay patients
- Currently scheduled for a colonoscopy or sigmoidoscopy
- Active order for multitarget stool DNA testing (MT-sDNA)
Show all 10Show fewer
- History of paraplegia or quadriplegia
- Elevated chance of mortality within 3 years according to mortality risk algorithm
- Active order for Fecal Immunochemical Test (FIT) in the last 60 days
- Positive stool test (FIT or MT-sDNA) result in the last 5 years
Trial locations and contacts
1 site in 1 country.
About this study
This is a 3-year pragmatic, randomized clinical trial among average-risk patients at diverse primary care practices who are overdue for colorectal (CRC) screening. This project aims to evaluate the effect of a centralized program that includes direct outreach to patients and visit-based, clinician directed nudges facilitated by the electronic health record (EHR) with follow-up text messaging on the uptake of CRC screening. The primary outcome is CRC screening completion at 3 years. Patient and clinician factors impacting the experience and effectiveness of the intervention will be explored through surveys and qualitative interviews.
Read the detailed description
Despite effective strategies for prevention, early detection, and treatment, colorectal cancer (CRC) remains the second leading cause of cancer death in the United States (US). While there have been considerable policy and system-level efforts to increase CRC screening rates, uptake remains well below national goals of 80% participation. Members of racial and ethnic minorities are even further behind. Approaches to increase population-based screening can consider [1] how screening is encouraged by targeting the clinicians who typically order or recommend the procedure or the patient who completes it; and [2] the kind of screening offered (e.g., colonoscopy or fecal immunochemical testing [FIT]). This project simultaneously tests interventions along both of these dimensions.
- Conditions
- Colorectal Cancer
- Being tested
- No Direct Patient Outreach, Direct Patient Outreach: Colonoscopy Only, Direct Patient Outreach: Sequential Choice, Visit-Based Nudge/Text, No Nudge/Text
- Keywords
- Prevention, Cancer Screening, Behavioral Economics
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Direct Patient OutreachBehavioural
Patient will not receive direct outreach prompting them to schedule and/or complete colorectal cancer screening.
Direct Patient Outreach: Colonoscopy OnlyBehavioural
Patient will receive direct outreach including an order to schedule and complete colonoscopy.
Direct Patient Outreach: Sequential ChoiceBehavioural
Patient will receive direct outreach including an order to schedule and complete colonoscopy then an at-home fecal immunochemical test (FIT) if colonoscopy is not completed.
Visit-Based Nudge/TextBehavioural
Patient's clinician will receive an alert prompting them to discuss colorectal cancer screening with their patient upon visit. Patient will also receive a text message 3 days after visit reminding them to complete colorectal cancer screening.
No Nudge/TextBehavioural
Patient's clinician will not receive an alert prompting them to discuss colorectal cancer screening with their patient upon visit. Patient will not receive a text message 3 days after visit reminding them to complete colorectal cancer screening.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1A: Usual Care | Experimental | 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. Receives: Behavioral: No Direct Patient Outreach; Behavioral: No Nudge/Text |
| Arm 2A: Colonoscopy Only and No Nudge/Text | Experimental | 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. Receives: Behavioral: Direct Patient Outreach: Colonoscopy Only; Behavioral: No Nudge/Text |
| Arm 2B: Colonoscopy Only and Visit-Based Nudge/Text | Experimental | 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. Receives: Behavioral: Direct Patient Outreach: Colonoscopy Only; Behavioral: Visit-Based Nudge/Text |
| Arm 3A: Sequential Choice and No Nudge/Text | Experimental | 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. Receives: Behavioral: Direct Patient Outreach: Sequential Choice; Behavioral: No Nudge/Text |
| Arm 3B: Sequential Choice and Visit-Based Nudge/Text | Experimental | 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. Receives: Behavioral: Direct Patient Outreach: Sequential Choice; Behavioral: Visit-Based Nudge/Text |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRC screening completion at 3 years
CRC screening completion at 3 years, which could be satisfied by any one of the following: colonoscopy completion at any time, negative FIT completed 2 times, or positive FIT followed by diagnostic colonoscopy within 1 year.
Measured: 3 years
Secondary outcomes (2)
CRC screening rate
CRC screening completion at 3 years by any modality
Measured: 3 years
Choice of test
The proportion of patients who complete CRC screening by screening type
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start7 Jun 2023
- Primary completion21 Dec 2026 (estimated)
- Study completion21 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shivan Mehta, Abramson Cancer Center at Penn Medicine
- Investigators
- Shivan Mehta, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693649
- Sponsor's protocol ID
- UPCC 14022
- Status last verified
- Oct 2026
- First submitted
- 12 Jan 2023
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mehta SJ, Shaw PA, Reitz C, Brophy C, Okorie E, Williams K, Segura A, Tao J, Snider CK, Wollack C, Friday S, Rendle KA, Klaiman T, Glanz K, Rhodes C, Asch DA. Sequential choice vs colonoscopy outreach for colorectal cancer screening: Design and rationale of a pragmatic randomized clinical trial. Contemp Clin Trials. 2026 Feb;161:108188. doi: 10.1016/j.cct.2025.108188. Epub 2025 Dec 16.
PubMed 41412475
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Economic Approaches for Population-Based Colorectal Cancer Screening
- ClinicalTrials.gov ID
- NCT05693649
- Acronym / sponsor ID
- UPCC 14022
- Conditions
- Colorectal Cancer
- Keywords
- Prevention, Cancer Screening, Behavioral Economics
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 21 Dec 2026 (estimated)
- Study completion
- 21 Dec 2026 (estimated)
- First posted
- 23 Jan 2023 (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.
This is a 3-year pragmatic, randomized clinical trial among average-risk patients at diverse primary care practices who are overdue for colorectal (CRC) screening. This project aims to evaluate the effect of a centralized program that includes direct outreach to patients and visit-based, clinician directed nudges facilitated by the electronic health record (EHR) with follow-up text messaging on the uptake of CRC screening. The primary outcome is CRC screening completion at 3 years. Patient and clinician factors impacting the experience and effectiveness of the intervention will be explored through surveys and qualitative interviews.
Detailed description
Despite effective strategies for prevention, early detection, and treatment, colorectal cancer (CRC) remains the second leading cause of cancer death in the United States (US). While there have been considerable policy and system-level efforts to increase CRC screening rates, uptake remains well below national goals of 80% participation. Members of racial and ethnic minorities are even further behind. Approaches to increase population-based screening can consider [1] how screening is encouraged by targeting the clinicians who typically order or recommend the procedure or the patient who completes it; and [2] the kind of screening offered (e.g., colonoscopy or fecal immunochemical testing [FIT]). This project simultaneously tests interventions along both of these dimensions.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1A: Usual Care | Experimental | Behavioral: No Direct Patient Outreach, Behavioral: No Nudge/TextPatients 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. |
| Arm 2A: Colonoscopy Only and No Nudge/Text | Experimental | Behavioral: Direct Patient Outreach: Colonoscopy Only, Behavioral: No Nudge/TextUsing 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. |
| Arm 2B: Colonoscopy Only and Visit-Based Nudge/Text | Experimental | Behavioral: Direct Patient Outreach: Colonoscopy Only, Behavioral: Visit-Based Nudge/TextUsing 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. |
| Arm 3A: Sequential Choice and No Nudge/Text | Experimental | Behavioral: Direct Patient Outreach: Sequential Choice, Behavioral: No Nudge/TextUsing 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. |
| Arm 3B: Sequential Choice and Visit-Based Nudge/Text | Experimental | Behavioral: Direct Patient Outreach: Sequential Choice, Behavioral: Visit-Based Nudge/TextUsing 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. |
Who may qualify
- Ages
- 50 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients ages 50-72
- Followed by Primary Care with a participating Penn Medicine PCP listed and at least one visit in the last 2 years
- Not up to date on colorectal cancer screening per Health Maintenance (no colonoscopy in the last 10 years, stool testing in the last year, flexible sigmoidoscopy in the last 5 years, MT-sDNA in the last 3 years).
Key exclusion criteria (10 listed)
- Personal or significant family history of CRC, colonic polyps, hereditary nonpolyposis colorectal cancer syndrome, familial adenomatous polyposis syndrome, other gastrointestinal cancer, gastrointestinal bleeding, iron-deficiency anemia, or inflammatory bowel disease
- History of total colectomy, dementia or metastatic cancer
- Currently on hospice or receiving palliative care
- Uninsured or self-pay patients
- Currently scheduled for a colonoscopy or sigmoidoscopy
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 |
|---|---|---|
| No Direct Patient OutreachPatient will not receive direct outreach prompting them to schedule and/or complete colorectal cancer screening. | Behavioural | Arm 1A: Usual Care |
| Direct Patient Outreach: Colonoscopy OnlyPatient will receive direct outreach including an order to schedule and complete colonoscopy. | Behavioural | Arm 2A: Colonoscopy Only and No Nudge/Text, Arm 2B: Colonoscopy Only and Visit-Based Nudge/Text |
| Direct Patient Outreach: Sequential ChoicePatient will receive direct outreach including an order to schedule and complete colonoscopy then an at-home fecal immunochemical test (FIT) if colonoscopy is not completed. | Behavioural | Arm 3A: Sequential Choice and No Nudge/Text, Arm 3B: Sequential Choice and Visit-Based Nudge/Text |
| Visit-Based Nudge/TextPatient's clinician will receive an alert prompting them to discuss colorectal cancer screening with their patient upon visit. Patient will also receive a text message 3 days after visit reminding them to complete colorectal cancer screening. | Behavioural | Arm 2B: Colonoscopy Only and Visit-Based Nudge/Text, Arm 3B: Sequential Choice and Visit-Based Nudge/Text |
| No Nudge/TextPatient's clinician will not receive an alert prompting them to discuss colorectal cancer screening with their patient upon visit. Patient will not receive a text message 3 days after visit reminding them to complete colorectal cancer screening. | Behavioural | Arm 1A: Usual Care, Arm 2A: Colonoscopy Only and No Nudge/Text, Arm 3A: Sequential Choice and No Nudge/Text |
Primary outcome
CRC screening completion at 3 years
Time frame: 3 years
CRC screening completion at 3 years, which could be satisfied by any one of the following: colonoscopy completion at any time, negative FIT completed 2 times, or positive FIT followed by diagnostic colonoscopy within 1 year.
2 secondary outcomes
CRC screening rate
Time frame: 3 years
Choice of test
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Derived from this study: PubMed 41412475Mehta SJ, Shaw PA, Reitz C, Brophy C, Okorie E, Williams K, Segura A, Tao J, Snider CK, Wollack C, Friday S, Rendle KA, Klaiman T, Glanz K, Rhodes C, Asch DA. Sequential choice vs colonoscopy outreach for colorectal cancer screening: Design and rationale of a pragmatic randomized clinical trial. Contemp Clin Trials. 2026 Feb;161:108188. doi: 10.1016/j.cct.2025.108188. Epub 2025 Dec 16.
- 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.
Shivan Mehta, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Direct Patient Outreach, Direct Patient Outreach: Colonoscopy Only and Direct Patient Outreach: Sequential Choice in people with Colorectal Cancer, run by Abramson Cancer Center at Penn Medicine 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 10 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: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
CRC screening completion at 3 years (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05693649, which also lists 1 linked publication.
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 5 Oct 2026.