Recruiting

Colonoscopy Surveillance

Sponsor:

Jonsson Comprehensive Cancer Center

Code:

NCT06376565

Conditions

Colorectal Carcinoma

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Best Practice

Communication Intervention

Communication Intervention

Communication Intervention

Interview

Study Details

Brief summary:

This clinical trial tests a multilevel intervention at the clinic, provider and patient levels, to improve colonoscopy surveillance in patients with high risk colon polyps. Colorectal cancer (CRC) is a common and deadly disease that is largely preventable through the detection and removal of colorectal polyps. One million Americans are diagnosed with high risk polyps of the colon or rectum annually and are at increased risk for CRC; however, uptake of recommended repeat colonoscopy in 3 years to reduce CRC risk is low in this group. This multilevel intervention may work to improve timely colonoscopy screening for patients with high risk colon polyps.

Conditions

Colorectal Carcinoma

Study ID

NCT06376565

Start date

Nov 8, 2023

Status verified date

Nov, 2025

Completion date

Nov 30, 2027

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • AIM 1 PATIENTS: Patients between age 45 and 75 with a HRN diagnosis in the past 5 years
  • AIM 1 PATIENTS: 12 patients who did and 12 patients who did not have surveillance colonoscopy
  • AIM 1 PROVIDERS: Primary care providers (PCPs) and gastroenterologists (GIs)
  • AIM 1 ADMINISTRATORS: Administrators who are involved in care processes related to CRC screening, HRN surveillance, and/or colonoscopy scheduling
  • AIM 2: Patients age 45 to 75 diagnosed with a HRN during the pre-specified two-year HRN diagnosis period

Exclusion Criteria:

  • AIM 2: Individuals with a personal history of colorectal carcinoma (CRC), inflammatory bowel disease (Crohn's, ulcerative colitis), or polyposis syndrome
  • AIM 2: HRN cases not confirmed by chart review (human-in-the-loop)

Study Design

Enrollment

1680 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Arm I(Multilevel intervention)

Aim 1: Participants complete an interview over 20-30 minutes.

Aim 2: Clinics have the automatic addition of HRN to the medical problem list and indication of surveillance interval is added to the health maintenance portion of the electronic health records (EHR). Clinics also call patients to schedule their colonoscopy. Providers receive reminders and pending orders for the colonoscopy in the electronic health record. Patients receive a reminder 6 months in advance via their patient portal and mail to schedule a colonoscopy, and also receive a phone call from the patient communication center.

active comparator: Arm II (Standard follow up)

Patients receive care according to the clinics' usual care practices.

Interventions

Best Practice

Receive standard care

Communication Intervention

Complete clinic EHR interventions

Communication Intervention

Receive scheduling reminders

Communication Intervention

Receive reminders and pending EHR orders

Interview

Complete interview

Interview

Ancillary studies

Primary outcome measure

  • Stakeholder perspectives on the multilevel intervention (Aim 1) [ Time Frame: At time of interview ]
  • Completion of surveillance colonoscopy (Aim 2) [ Time Frame: At 3.5 years ]
  • Implementation quality (Aim 3a) [ Time Frame: Up to 3 years ]
  • Cost effectiveness (Aim 3b) [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Jenna Alarcon

310-794-6197JCAlarcon@mednet.ucla.edu

Locations

UCLA / Jonsson Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Jenna Alarcon

310-794-6197jcalarcon@mednet.ucla.edu

Principal Investigator:

Folasade P. May

More Information

Sponsor

Jonsson Comprehensive Cancer Center

Last update posted

Nov 14, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center on 2025-11-14.