Clinical trial NCT04831827: Promoting Equity for Cancer Screening and Follow-up
Official title: Promoting Equity Through Multicomponent Strategies for Cancer Screening and Follow-up (PREMiS)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colorectal (Colon or Rectal) Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a randomized trial to assess the efficacy of reminder mechanisms on colorectal cancer (CRC) screening uptake among a cohort of patients who were previously mailed a multitarget stool DNA (mt-sDNA) test and did not complete the screening. Patients will be identified as being due for CRC screening and will be mailed a mt-sDNA kit to their home. Patients who do not complete screening with mt-sDNA within 30 days will be identified and randomized into one of three study arms to receive reminders to complete the mt-sDNA screening. The primary outcome is the rate of completion of screening for colorectal cancer with mt-sDNA test.

Detailed description: Colorectal cancer (CRC) is the third leading cause of cancer-related death in the United States, and screening has been shown to reduce mortality from CRC. Screening is underutilized in the United States, particularly in some communities such as Blacks/African Americans, American Indians/Alaskan Natives, and rural populations, contributing to disparities in mortality.

For CRC screening, mt-sDNA testing is one of several tests that are recommended by the United States Preventive Services Task Force (USPSTF). As part of a quality improvement program at our institution, those who are due for CRC screening are identified using a validated electronic algorithm and a kit is mailed directly to each patient. Our intervention is initiated on non-respondents to the mailed mt-sDNA outreach by testing the use of a technology-enabled reminder system.

Thirty days after being mailed a mt-sDNA kit, patients who have not completed the screening will be randomized to receive a reminder to complete the mt-sDNA screening by one of three mechanisms (time 0):

1. Automated reminder using the EHR patient portal messaging system.
2. Automated reminder using a customized interactive voice response (IVR) system
3. Personalized reminder phone calls from the clinical team

This will allow for an empirical test of processes that can be employed to improve delivery of CRC screening and reduce preventable deaths in populations that are underserved with evidence-based interventions.

Eligibility criteria: Inclusion Criteria:

* Adults, between 50 to 75 years old.
* Due for colorectal cancer screening based on not having a record of a colonoscopy within 10 years, sigmoidoscopy, or CT colonography within 5 years, mt-sDNA within 3 years, or FIT within 1 year.
* Asymptomatic for colorectal cancer such as rectal bleeding or reported abdominal mass.

Exclusion Criteria:

* For the intervention study, patients will be restricted to those aged 50 to 75 years and are due for colorectal cancer screening.
* We will exclude any patient who has:
* Had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, mt-sDNA within 3 years, CT colonography within 5 years, and FOBT/FIT within twelve months of inclusion into the study;
* A diagnosis of CRC or other GI cancer;
* History of confirmed Inflammatory Bowel Disease (Crohn's disease, ulcerative colitis) or other colitis;
* Had a colectomy, partial or total;
* A diagnosis of Lynch Syndrome;
* A diagnosis of Familial Adenomatous Polyposis (FAP);
* Iron deficiency anemia;
* Lower GI bleeding;
* A metastatic (Stage IV) blood or solid tumor cancer;
* End stage renal disease;
* A first degree relative with CRC prior to age 50 or 2+ first degree relatives diagnosed at any age.

Primary outcomes:
measure: Primary Endpoint (intention-to-treat)
timeFrame: Completion by 6 months post randomization
Secondary outcomes:
measure: Secondary Outcome (per protocol analysis)
timeFrame: Completion by 6 months post randomization
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Chyke Doubeni, MBBS, MPH
role: PRINCIPAL_INVESTIGATOR
References: