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Recruiting NCT06542835

Community Partnership for Telehealth Solutions to Convey Information and Enhance Care

No phase Interventional Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Video text message, In-clinic CRC screening promotion, Mailed FIT, Social needs navigation.
Who it may be relevant to
Registry conditions: Colorectal Cancer. Basic parameters: 45 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Community Partnership for Telehealth Solutions to Counter Misinformation and Achieve Equity

Overview

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

Detailed description

The PRIME study aims to improve colorectal cancer (CRC) screening and follow-up among predominantly Latinx populations by using video text messages, mailed FIT kits, and patient navigation. The study will address multi-level barriers to screening, including misinformation, lack of access, and social determinants of health. The hypothesis is that a multi-component intervention will increase CRC screening rates and follow-up care, reducing disparities in CRC outcomes.

Interventions

  • Behavioral Video text message
    Video text messages tailored to the Latinx population to educate and motivate patients to complete CRC screening.
  • Behavioral In-clinic CRC screening promotion
    Stool-test orders, colonoscopy referrals.
  • Behavioral Mailed FIT
    Mailed FIT kits.
  • Behavioral Social needs navigation
    Patient navigation to address social needs.
  • Behavioral Reminders
    Centralized text and/or telephone reminders for ordered tests.

Primary outcome measures

  • CRC Screening Completion at the Individual Level [Time frame: 6 months]
Secondary outcome measures (3)
  • FIT completion [Time frame: 6 months]
  • Rate of Follow-Up Colonoscopy Completion [Time frame: 12 months]
  • Time to follow-up colonoscopy [Time frame: Within 12 months post abnormal FIT result]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Screening

Study locations

United States · 1 center
  • AltaMed Health Services Corporation — Los Angeles

Publications

  • 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 40526315

Identifiers

NCT: NCT06542835 · STUDY00004612

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗