The PRIME-CRC Trial to Promote CRC Screening in Rural Communities

NCT04313114 | Active Not Recruiting DMC

• 2 other identifiers: LSUShreveport5R01CA240496
• Study Type: interventional
• Target: 804
• Locations: 1 country
• Sites: 3

Brief Summary

The investigators will expand an existing, patient-centered, health literacy strategy to promote longer-term adherence to colorectal cancer (CRC) screening in resource-limited, rural health clinics via colonoscopy or annual fecal immunochemical test (FIT). In the proposed 2-arm study, both PRIME-CRC and enhanced usual care (control) will incorporate health literacy evidence-based practices for delivering CRC patient information and counseling to aid patient decision making for selecting FIT or colonoscopy, including simplified test instructions. In addition, the PRIME-CRC arm will use a "stepped care" approach for reminding patients on proper CRC screening preparation for scheduled colonoscopy or completion of annual FIT. Patients in the PRIME-CRC arm will receive frequent follow-up contact from their health care provider via audio-recorded, automated call or SMS text, based on patient preference.

Conditions

Colorectal Cancer

Keywords

health literacy; shared decision making; colonoscopy; fecal immunochemical test; rural community clinics

Outcome Measures

Primary Outcomes (1)

• CRC Screening

  completion of colonoscopy or 3 years of completion of FIT CRC screening

  3 years

Study Arms (2)

PRIME CRC

ACTIVE COMPARATOR

Patients will receive a plain language, literacy appropriate, actionable printed CRC screening handout emphasizing the benefits of CRC screening and screening options; as well as plain language, literacy appropriate handouts on the CRC screening test they choose - colonoscopy or FIT. Patients will also receive automated reminder calls and texts for both screening options to encourage screening.

Behavioral: health literacy appropriate education and demonstration; Behavioral: shared decision making; Behavioral: automated call reminders or automated texts

Enhanced Usual Care

ACTIVE COMPARATOR

Patients will receive a plain language, literacy appropriate, actionable printed CRC screening handout emphasizing the benefits of CRC screening and screening options; as well as plain language, literacy appropriate handouts on the CRC screening test they choose - colonoscopy or FIT. Patients will receive no reminder calls.

Behavioral: health literacy appropriate education and demonstration; Behavioral: shared decision making

Interventions

health literacy appropriate education and demonstration BEHAVIORAL

If a patient chooses the Fecal Immunochemical Test (FIT), the Screening Coordinator (SC) will give the FIT kit, emphasize the necessity of annual completion, and distribute an additional plain language, literacy appropriate, actionable handout with simplified illustrated instructions on how to complete the test and mail to the central lab. The SC will review the handout and instructions with the patient and use the 'teach back' method to confirm understanding.

Enhanced Usual Care; PRIME CRC

shared decision making BEHAVIORAL

Screening Coordinator (SC) will give patients a plain language, literacy appropriate, actionable printed CRC screening handout emphasizing the benefits of CRC screening and screening options; using the low literacy handout as a teaching tool, the SC will briefly counsel patients on CRC screening options prior to seeing their healthcare provider, reviewing the benefits of each, as well as applicable costs. After reviewing the CRC screening pamphlets with a patient, the SC will use shared decision-making techniques using the study CRC materials to aid patients in selecting the test they prefer and that meets their needs - colonoscopy or FIT.

Enhanced Usual Care; PRIME CRC

automated call reminders or automated texts BEHAVIORAL

Colonoscopy year 1: Will receive an automated call recording by PCP 48 hours after the clinic visit to remind them of their choice of colonoscopy; then, one week before the test reminding them to pick up the preparation kit. Those who chose SMS will receive a text message from their PCP with content similar to the voice call. A 3rd reminder call/text will be sent 2 days prior to the test. If no colonoscopy with 3 months, the clinical manager (CCM) will call to determine if they want to switch screening options. The CCM will discuss barriers and option of choosing FIT for 3 years. If they opt to change, they will be mailed a FIT with simplified instructions and then follow the FIT follow-up protocol. FIT year 1: Motivational reminders recorded by their PCP will be sent by automated call or text within 48 hours after the visit and again at 4, 8 and 12 weeks for those who have NOT completed the test. FIT will be mailed year 2 \& 3 - follow-up will follow same procedure as year 1.

PRIME CRC

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have been a patient at one of the participating FQHCs with at least one prior visit in the past 12 months;
• age 45 to 75 (based on USPSTF guidelines);
• English-speaking.

You may not qualify if:

• have a previous history of cancer other than non-melanoma skin cancer;
• are up-to-date with CRC screening according to USPSTF guidelines (FOBT in less than a year, sigmoidoscopy less than 5 years, or colonoscopy less than 10 years);
• a family history that requires a more complete history and possible colonoscopy because of their risk factor;
• have a documented or uncorrectable cognitive, hearing, or visual impairment;
• are too ill to participate

Sponsors & Collaborators

• Louisiana State University Health Sciences Center Shreveport: lead
• National Cancer Institute (NCI): collaborator
• Northwestern University: collaborator

Study Sites (3)

CommuniHealth (dba Morehouse Community Medical Centers, Inc.)

Bastrop, Louisiana, 71220-5013, United States

Location

CommuniHealth (dba Morehouse Community Medical Centers, Inc.)

Marion, Louisiana, 71260-3653, United States

Location

Tensas Community Health Centers

Saint Joseph, Louisiana, 71366, United States

Location

Related Publications (1)

• Davis TC, Morris JD, Reed EH, Curtis LM, Wolf MS, Davis AB, Arnold CL. Design of a randomized controlled trial to assess the comparative effectiveness of a multifaceted intervention to improve three-year adherence to colorectal cancer screening among patients cared for in rural community health centers. Contemp Clin Trials. 2022 Feb;113:106654. doi: 10.1016/j.cct.2021.106654. Epub 2021 Dec 11.

  PMID: 34906745 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

• Connie L Arnold, PhD

  LSU Health Sciences Center Shreveport

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 18, 2020
• Study Start: September 20, 2021
• Primary Completion: December 1, 2025
• Study Completion: May 31, 2026
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)