NCT06542835

Brief Summary

Non-randomized, two-arm stepped-wedge trial of a multi-level colorectal cancer screening intervention.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,000

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
7mo left

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Jul 2024Jan 2027

First Submitted

Initial submission to the registry

July 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

July 31, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2.2 years

First QC Date

July 19, 2024

Last Update Submit

March 24, 2026

Conditions

Colorectal Cancer

Keywords

cancer screeningtelehealthvideotext messagingpatient navigationstool testingfecal testingLatinx health disparities

Outcome Measures

Primary Outcomes (1)

  • CRC Screening Completion at the Individual Level

    Measure the completion rate of colorectal cancer (CRC) screening at the individual level within 6 months of receiving the intervention. This will compare the proportion of participants in the post-intervention group versus the pre-intervention group.

    6 months

Secondary Outcomes (3)

  • FIT completion

    6 months

  • Rate of Follow-Up Colonoscopy Completion

    12 months

  • Time to follow-up colonoscopy

    Within 12 months post abnormal FIT result

Study Arms (2)

Video text message, mailed FIT, and social needs navigation

EXPERIMENTAL

Tailored video text message, mailed FIT, and navigation to address patients' social needs.

Behavioral: Video text messageBehavioral: Mailed FITBehavioral: Social needs navigation

Usual care

ACTIVE COMPARATOR

Colorectal cancer (CRC) screening offers during in-person clinic visits.

Behavioral: In-clinic CRC screening promotionBehavioral: Reminders

Interventions

Video text messageBEHAVIORAL

Video text messages tailored to the Latinx population to educate and motivate patients to complete CRC screening.

Video text message, mailed FIT, and social needs navigation
Mailed FITBEHAVIORAL

Mailed FIT kits.

Video text message, mailed FIT, and social needs navigation
In-clinic CRC screening promotionBEHAVIORAL

Stool-test orders, colonoscopy referrals.

Usual care
Social needs navigationBEHAVIORAL

Patient navigation to address social needs.

Video text message, mailed FIT, and social needs navigation
RemindersBEHAVIORAL

Centralized text and/or telephone reminders for ordered tests.

Usual care

Eligibility Criteria

Age45 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Ages 45-64
  • Eligible for colorectal cancer (CRC) screening
  • Current patients (seen in the clinic in the last 6 months)
  • Primary speaker of English or Spanish
  • Cell phone listed in Electronic Health Record (EHR)
  • No recent history of CRC screening
  • Resides in one of the neighborhoods included in the main trial

You may not qualify if:

  • Colorectal disease (e.g., ulcerative colitis or colectomy)
  • Personal history of colorectal cancer
  • End-stage or life-threatening diseases
  • Known to be under hospice care
  • Living in a skilled nursing facility
  • Patients who decline research participation will be removed from the patient contact list

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AltaMed Health Services Corporation

Los Angeles, California, 90040, United States

RECRUITING

Related Publications (1)

  • Rivelli JS, Schneider JL, Vaughn KA, Locher BW, Shaw MC, Martinez LS, Ruiz E, Thompson JH, Escaron AL, Coronado GD. Improving animated instructional videos for colorectal cancer screening: An application of learner verification and revision. Transl Behav Med. 2025 Jan 16;15(1):ibaf020. doi: 10.1093/tbm/ibaf020.

    PMID: 40526315DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Anne Escaron, PhD

    AltaMed Health Services Corporation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gloria Coronado, PhD

CONTACT

5039147100gdcoronado@arizona.edu

Katherine Mendoza, MPH

CONTACT

8477672847katherinemendoza@arizona.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 19, 2024

First Posted

August 7, 2024

Study Start

July 31, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)