Clinical trial · Interventional
Participatory Research to Advance Colon Cancer Prevention
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The overall goal of this study is to test strategies to raise rates of colorectal cancer screening among the Latino population in a federally qualified health center that operates multiple clinics. This intervention study will test automated and live prompts to a direct-mail fecal testing program in two phases. In Phase I (Years 01 - 02), the investigators will tailor and define intervention components using a community-based participatory research approach called boot camp translation (BCT). The ultimate design of the intervention will be defined by patient and provider feedback from BCT. The investigators will then conduct a three-arm patient-randomized comparative effectiveness trial in two pilot clinics to compare 1) automated prompts (i.e., automated phone calls, text messages) to alert and remind patients to complete screening, 2) live prompts (i.e., live phone calls), and 3) a combination approach of automated plus live prompts. In Phase II (Years 03 - 05), the investigators will spread and test the spread of the adapted intervention to additional clinics within the partnering health center using a two-arm main trial. Both phases will be guided by an advisory group of clinicians, researchers, policy makers, and patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Automated Plus Live Prompts | Other | — | UNRESOLVED |
| Automated Prompts | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Automated Prompts
- description
- Patients randomized to this arm will receive automated prompts to complete and return the FIT kit.
- interventionNames
- Other: Automated Prompts
- type
- ACTIVE_COMPARATOR
- label
- Automated Plus Live Prompts
- description
- Patients randomized to this arm will receive automated prompts plus linguistically and culturally tailored live prompts to complete and return the FIT kit.
- interventionNames
- Other: Automated Plus Live Prompts
- type
- NO_INTERVENTION
- label
- Usual Care
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Persons aged 50-75 years and not up-to-date with colorectal cancer screening Exclusion Criteria: * Persons having colorectal disease (e.g., ulcerative colitis or colectomy), personal history of colorectal cancer or colorectal disease, end-stage or life threatening diseases or, those known to be under hospice care or living in a skilled nursing facility may be excluded.
References
Publications (6)
- DERIVEDCoronado GD, Nyongesa DB, Escaron AL, Petrik AF, Thompson JH, Smith D, Davis MM, Schneider JL, Rivelli JS, Laguna T, Leo MC. Effectiveness and Cost of an Enhanced Mailed Fecal Test Outreach Colorectal Cancer Screening Program: Findings from the PROMPT Stepped-Wedge Trial. Cancer Epidemiol Biomarkers Prev. 2023 Nov 1;32(11):1608-1616. doi: 10.1158/1055-9965.EPI-23-0597. PMID 37566431
- DERIVEDSchneider JL, Rivelli JS, Vaughn KA, Thompson JH, Petrik AF, Escaron AL, Coronado GD. Implementing an enhanced mailed FIT program to improve CRC screening at a federally qualified health center: experiences of patients and staff. Transl Behav Med. 2023 Sep 28;13(10):757-767. doi: 10.1093/tbm/ibad025. PMID 37210075
- DERIVEDDavis MM, Schneider JL, Petrik AF, Miech EJ, Younger B, Escaron AL, Rivelli JS, Thompson JH, Nyongesa D, Coronado GD. Clinic Factors Associated With Mailed Fecal Immunochemical Test (FIT) Completion: The Difference-Making Role of Support Staff. Ann Fam Med. 2022 Mar-Apr;20(2):123-129. doi: 10.1370/afm.2772. PMID 35346927
- DERIVEDCoronado GD, Nyongesa DB, Petrik AF, Thompson JH, Escaron AL, Younger B, Harbison S, Leo MC. Randomized Controlled Trial of Advance Notification Phone Calls vs Text Messages Prior to Mailed Fecal Test Outreach. Clin Gastroenterol Hepatol. 2021 Nov;19(11):2353-2360.e2. doi: 10.1016/j.cgh.2020.07.053. Epub 2020 Jul 30. PMID 32739569
- DERIVEDCoronado GD, Thompson JH, Petrik AF, Nyongesa DB, Leo MC, Castillo M, Younger B, Escaron A, Chen A. Patient-Refined Messaging for a Mailed Colorectal Cancer Screening Program: Findings from the PROMPT Study. J Am Board Fam Med. 2019 May-Jun;32(3):318-328. doi: 10.3122/jabfm.2019.03.180275. PMID 31068396
- DERIVEDThompson JH, Davis MM, Leo MC, Schneider JL, Smith DH, Petrik AF, Castillo M, Younger B, Coronado GD. Participatory Research to Advance Colon Cancer Prevention (PROMPT): Study protocol for a pragmatic trial. Contemp Clin Trials. 2018 Apr;67:11-15. doi: 10.1016/j.cct.2018.02.001. Epub 2018 Feb 9.