Participatory Research to Advance Colon Cancer Prevention

NCT03167125 | Completed DMC

• 1 other identifier: 1U01MD010665-01
• Study Type: interventional
• Target: 27,580
• Locations: 1 country
• Sites: 1

Brief Summary

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

Colorectal Cancer

Keywords

colorectal cancer screening; cancer screening; pragmatic trial; boot camp translation

Outcome Measures

Primary Outcomes (1)

• Increased colorectal cancer screening rates

  Fecal testing completion

  Up to 4 years (study period)

Study Arms (3)

Automated Prompts

ACTIVE COMPARATOR

Patients randomized to this arm will receive automated prompts to complete and return the FIT kit.

Other: Automated Prompts

Automated Plus Live Prompts

ACTIVE COMPARATOR

Patients randomized to this arm will receive automated prompts plus linguistically and culturally tailored live prompts to complete and return the FIT kit.

Other: Automated Plus Live Prompts

Usual Care

NO INTERVENTION

Patients randomized to this arm will receive usual care screening opportunities per recommended colorectal cancer screening guidelines.

Interventions

Automated Prompts OTHER

This intervention is an automated data-driven program, using automated phone calls, text messages, and/or emails, for delivering FIT kit prompts to patients due for colorectal cancer screening. The specific components of the intervention are forthcoming and will be determined using a community-based participatory research approach known as boot camp translation which seeks input from patients and providers.

Automated Prompts

Automated Plus Live Prompts OTHER

This intervention is a higher-intensity program, using automated data-driven prompts plus linguistically and culturally tailored live prompts, for delivering FIT kit messages to patients due for colorectal cancer screening. The specific components of the intervention are forthcoming and will be determined using a community-based participatory research approach known as boot camp translation which seeks input from patients and providers.

Automated Plus Live Prompts

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons aged 50-75 years and not up-to-date with colorectal cancer screening

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaiser Permanente: lead
• Oregon Health and Science University: collaborator
• AltaMed Health Services Corporation: collaborator

Study Sites (1)

AltaMed Health Services

Los Angeles, California, 90040, United States

Location

Related Publications (6)

• Coronado 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 DERIVED

• Schneider 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 DERIVED

• Davis 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 DERIVED

• Coronado 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 DERIVED

• Coronado 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 DERIVED

• Thompson 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.

  PMID: 29408304 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Gloria Coronado, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase I: The investigators will conduct a three-arm patient-randomized trial to compare 1) usual care, 2) automated prompts, and 3) automated plus live prompts. (Number of Arms: 3) Phase II: This spread trial will use a stepped-wedge design, which is a variant of a crossover randomized trial, where clinics cross over from usual practice to the best practices program. In the stepped-wedge design, a baseline period controls for the level and rate of change of the outcomes prior to program implementation and the staggered implementation minimizes confounding due to changes in the secular trend. By randomizing practices to when they receive an intervention instead of whether they receive it, the stepped wedge design ensures that all practices eventually receive the intervention, an important consideration for clinic leadership. Furthermore, the wedge-defined clusters act as their own controls as they each receive both intervention conditions. (Number of Arms: 2)

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 25, 2017
• Study Start: September 5, 2017
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2021
• Last Updated: April 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)