Colon CancerIMPACTTNCT06191185
IMProving Adherence to Colonoscopy Through Teams and Technology
A study testing BPB, No PIN, BPB, PIN and No BPB, PIN in people with Colon Cancer and Cancer Colorectal, run by University of California, San Francisco at 1 site in United States.
Trial summary
Complete and timely colonoscopy after an abnormal stool-based colorectal cancer screening test results in early detection, cancer prevention, and reduction in mortality, but follow-up in safety-net health systems occurs in less than 50% at 6 months. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer, Cancer Colorectal, Colorectal Cancer
- What is being tested?
- BPB, No PIN, BPB, PIN and No BPB, PIN
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,418 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2024to 28 Feb 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with abnormal FIT result
- Patients ages 18 years or older
- English, Spanish, or Cantonese speaking
Who cannot join
- Patients with normal FIT result
- Patients younger than age 18
Trial locations and contacts
1 site in 1 country.
United States1 site
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
About this study
Complete and timely colonoscopy after an abnormal stool-based colorectal cancer screening test results in early detection, cancer prevention, and reduction in mortality, but follow-up in safety-net health systems occurs in less than 50% at 6 months. The proposal will implement multi-level approach consisting of a stepped-wedge clinic-level intervention of team-based best practices co-developed with primary and specialty care, a patient-level technology intervention to provide enhanced instructions and navigation to complete diagnostic colonoscopy, and a mixed methods evaluation to explore multi-level factors contributing to intervention outcomes. Developing a solution to this high-risk and diverse population has the potential to translate to other health systems, support patient self-management, and address other patient conditions.
Read the detailed description
Follow-up colonoscopy after abnormal stool-based colorectal cancer screening (e.g., fecal immunochemical test (FIT)) results in early detection of colorectal cancer (CRC), prevention of CRC, and reduction in CRC mortality. FIT is a commonly utilized screening test that can be performed at home, is inexpensive, scalable, and often adopted in health systems where colonoscopy resources are scarce. Despite evidence that timely colonoscopy is necessary after an abnormal FIT result, completion of colonoscopy occurs in less than 50% of patients at 6 months and varies significantly by clinic and health systems. In addition to understanding the meaning of an abnormal FIT, three care transitions must occur smoothly for the patient: colonoscopy referral, scheduling, and attendance. However, multilevel factors influence missed follow-up, and multilevel solutions are needed along the care continuum to address clinic-, provider-, and patient-level factors that impair or delay colonoscopy completion.
IMProving Adherence to Colonoscopy through Teams and Technology (IMPACTT), proposes to close gaps and reduce disparities in CRC screening by improving the completion of diagnostic colonoscopy following abnormal FIT in vulnerable populations using a multilevel approach consisting of interventions at the clinic-, provider- and patient-level. The specific aims are 1) to evaluate the effect of a clinic-level intervention targeting primary care providers and staff to adopt "best practices" to support colonoscopy completion in patients with abnormal FIT results, 2) to determine the effect of a patient-level technology intervention with enhanced instructions and navigation for patients with abnormal FIT to complete a diagnostic colonoscopy, and 3) to explore the multilevel implementation factors contributing to intervention outcomes using mixed methods.
- Conditions
- Colon Cancer, Cancer Colorectal, Colorectal Cancer
- Being tested
- BPB, No PIN, BPB, PIN, No BPB, PIN, No BPB, No PIN
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPB, No PINBehavioural
Patient-level: standard communication from care team.
Clinic-level: A program of "best practices" will be implemented to improve team communication, optimize practice workflow, and identify and track patients with abnormal FIT results through colonoscopy completion.
BPB, PINBehavioural
Patient-level: The patient-facing evidence-based instructions, communication, and navigation part of the intervention will leverage the short messaging service (SMS) text messaging platform, HealthySMS.
Clinic-level: A program of "best practices" will be implemented to improve team communication, optimize practice workflow, and identify and track patients with abnormal FIT results through colonoscopy completion.
No BPB, PINBehavioural
Patient-level: The patient-facing evidence-based instructions, communication, and navigation part of the intervention will leverage the SMS text messaging platform, HealthySMS.
No BPB, No PINBehavioural
Patient-level: standard communication from their care team.
| Study group | Role | What they receive |
|---|---|---|
| Best Practices Bundle (BPB), No Patient Instructions and Navigation (PIN) | Experimental | BPB: patient tracking and lists, audit and feedback, standardized documentation, standardization of care team communication.
No PIN: Patients will receive usual communication from their care team. Receives: Behavioral: BPB, No PIN |
| BPB, PIN | Experimental | BPB: patient tracking and lists, audit and feedback, standardized documentation, standardization of care team communication.
PIN: enhanced patient instructions and navigation (PIN). Receives: Behavioral: BPB, PIN |
| No BPB, PIN | Experimental | No BPB: Clinic's usual practice after a patient receives an abnormal FIT result.
PIN: enhanced patient instructions and navigation (PIN). Receives: Behavioral: No BPB, PIN |
| No BPB, No PIN | Experimental | No BPB: Clinic's usual practice after a patient receives an abnormal FIT result.
No PIN: Patients will receive usual communication from their care team. Receives: Behavioral: No BPB, No PIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonoscopy completion
Wait time for routine colonoscopy is often less than 6 weeks and less than 2 weeks if one is willing to take an afternoon appointment. Completion of colonoscopy will be captured by extracting pertinent colonoscopy elements
Measured: 6 months after abnormal FIT result
Secondary outcomes (3)
Quality of bowel preparation
The quality of procedure preparation is defined as excellent, good, fair, and poor.
Measured: At time of colonoscopy procedure
Referred to GI for colonoscopy
After an abnormal FIT result, providers should review the test result, communicate with patients, and refer the patient to GI to complete a colonoscopy.
Measured: 6 weeks after abnormal FIT result
Scheduled by GI for colonoscopy
After an abnormal FIT result, providers will refer patients. The electronic referral is reviewed by GI, who will call the patient to schedule the colonoscopy.
Measured: 8 weeks after GI referral
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start8 Jul 2024
- Primary completion27 Nov 2026 (estimated)
- Study completion28 Feb 2027 (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 Colon CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,418 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ma Somsouk, MD, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191185
- Sponsor's protocol ID
- P0555149
- Other IDs
- R01CA271031, NCI-2025-07415
- Acronym
- IMPACTT
- Status last verified
- Oct 2026
- First submitted
- 20 Dec 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang K, Wong J, Avilez L, Olazo K, Olanrewaju S, McCulloch CE, Pasick R, Patel S, Somsouk M, Sarkar U. Multilevel intervention for follow-up of abnormal FIT in the safety-net: IMProving Adherence to Colonoscopy through Teams and Technology (IMPACTT). Contemp Clin Trials. 2025 Mar;150:107810. doi: 10.1016/j.cct.2025.107810. Epub 2025 Jan 12.
PubMed 39809342
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMProving Adherence to Colonoscopy Through Teams and Technology
- ClinicalTrials.gov ID
- NCT06191185
- Acronym / sponsor ID
- IMPACTT / P0555149
- Conditions
- Colon Cancer, Cancer Colorectal, Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,418 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 27 Nov 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 5 Jan 2024 (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.
Complete and timely colonoscopy after an abnormal stool-based colorectal cancer screening test results in early detection, cancer prevention, and reduction in mortality, but follow-up in safety-net health systems occurs in less than 50% at 6 months. The proposal will implement multi-level approach consisting of a stepped-wedge clinic-level intervention of team-based best practices co-developed with primary and specialty care, a patient-level technology intervention to provide enhanced instructions and navigation to complete diagnostic colonoscopy, and a mixed methods evaluation to explore multi-level factors contributing to intervention outcomes. Developing a solution to this high-risk and diverse population has the potential to translate to other health systems, support patient self-management, and address other patient conditions.
Detailed description
Follow-up colonoscopy after abnormal stool-based colorectal cancer screening (e.g., fecal immunochemical test (FIT)) results in early detection of colorectal cancer (CRC), prevention of CRC, and reduction in CRC mortality. FIT is a commonly utilized screening test that can be performed at home, is inexpensive, scalable, and often adopted in health systems where colonoscopy resources are scarce. Despite evidence that timely colonoscopy is necessary after an abnormal FIT result, completion of colonoscopy occurs in less than 50% of patients at 6 months and varies significantly by clinic and health systems. In addition to understanding the meaning of an abnormal FIT, three care transitions must occur smoothly for the patient: colonoscopy referral, scheduling, and attendance. However, multilevel factors influence missed follow-up, and multilevel solutions are needed along the care continuum to address clinic-, provider-, and patient-level factors that impair or delay colonoscopy completion.
IMProving Adherence to Colonoscopy through Teams and Technology (IMPACTT), proposes to close gaps and reduce disparities in CRC screening by improving the completion of diagnostic colonoscopy following abnormal FIT in vulnerable populations using a multilevel approach consisting of interventions at the clinic-, provider- and patient-level. The specific aims are 1) to evaluate the effect of a clinic-level intervention targeting primary care providers and staff to adopt "best practices" to support colonoscopy completion in patients with abnormal FIT results, 2) to determine the effect of a patient-level technology intervention with enhanced instructions and navigation for patients with abnormal FIT to complete a diagnostic colonoscopy, and 3) to explore the multilevel implementation factors contributing to intervention outcomes using mixed methods.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Best Practices Bundle (BPB), No Patient Instructions and Navigation (PIN) | Experimental | Behavioral: BPB, No PINBPB: patient tracking and lists, audit and feedback, standardized documentation, standardization of care team communication. No PIN: Patients will receive usual communication from their care team. |
| BPB, PIN | Experimental | Behavioral: BPB, PINBPB: patient tracking and lists, audit and feedback, standardized documentation, standardization of care team communication. PIN: enhanced patient instructions and navigation (PIN). |
| No BPB, PIN | Experimental | Behavioral: No BPB, PINNo BPB: Clinic's usual practice after a patient receives an abnormal FIT result. PIN: enhanced patient instructions and navigation (PIN). |
| No BPB, No PIN | Experimental | Behavioral: No BPB, No PINNo BPB: Clinic's usual practice after a patient receives an abnormal FIT result. No PIN: Patients will receive usual communication from their care team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with abnormal FIT result
- Patients ages 18 years or older
- English, Spanish, or Cantonese speaking
Key exclusion criteria (2 listed)
- Patients with normal FIT result
- Patients younger than age 18
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 |
|---|---|---|
| BPB, No PINPatient-level: standard communication from care team. Clinic-level: A program of "best practices" will be implemented to improve team communication, optimize practice workflow, and identify and track patients with abnormal FIT results through colonoscopy completion. | Behavioural | Best Practices Bundle (BPB), No Patient Instructions and Navigation (PIN) |
| BPB, PINPatient-level: The patient-facing evidence-based instructions, communication, and navigation part of the intervention will leverage the short messaging service (SMS) text messaging platform, HealthySMS. Clinic-level: A program of "best practices" will be implemented to improve team communication, optimize practice workflow, and identify and track patients with abnormal FIT results through colonoscopy completion. | Behavioural | BPB, PIN |
| No BPB, PINPatient-level: The patient-facing evidence-based instructions, communication, and navigation part of the intervention will leverage the SMS text messaging platform, HealthySMS. | Behavioural | No BPB, PIN |
| No BPB, No PINPatient-level: standard communication from their care team. | Behavioural | No BPB, No PIN |
Primary outcome
Colonoscopy completion
Time frame: 6 months after abnormal FIT result
Wait time for routine colonoscopy is often less than 6 weeks and less than 2 weeks if one is willing to take an afternoon appointment. Completion of colonoscopy will be captured by extracting pertinent colonoscopy elements
3 secondary outcomes
Quality of bowel preparation
Time frame: At time of colonoscopy procedure
Referred to GI for colonoscopy
Time frame: 6 weeks after abnormal FIT result
Scheduled by GI for colonoscopy
Time frame: 8 weeks after GI referral
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 20 Oct 2026.
- Derived from this study: PubMed 39809342Wang K, Wong J, Avilez L, Olazo K, Olanrewaju S, McCulloch CE, Pasick R, Patel S, Somsouk M, Sarkar U. Multilevel intervention for follow-up of abnormal FIT in the safety-net: IMProving Adherence to Colonoscopy through Teams and Technology (IMPACTT). Contemp Clin Trials. 2025 Mar;150:107810. doi: 10.1016/j.cct.2025.107810. Epub 2025 Jan 12.
- Individual participant dataSharing planned: No
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Colon Cancer
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.
Ma Somsouk, MD, MAS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BPB, No PIN, BPB, PIN and No BPB, PIN in people with Colon Cancer and Cancer Colorectal, run by University of California, San Francisco 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 2 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 20 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?
Colonoscopy completion (time frame: 6 months after abnormal FIT result). 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 NCT06191185, 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 20 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.