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Promoting Equity for Cancer Screening and Follow-up

NCT ID: NCT04831827

Last Updated: 2021-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2023-05-31

Brief Summary

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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

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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.

Conditions

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Colorectal (Colon or Rectal) Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators
Investigators will be blinded to study arm; research coordinators will not be blinded because it is not practical to do so, but steps will be taken to minimize their awareness about study hypotheses.

Study Groups

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IVR Reminder

Participants will receive an interactive voice reminder

Group Type EXPERIMENTAL

IVR Reminder

Intervention Type OTHER

Participants will receive an interactive voice reminder (IVR) to complete mt-sDNA screening at day 7 and 21.

Personalized Phone Call Reminder

Participants will receive a personalized phone call

Group Type ACTIVE_COMPARATOR

Phone call from research team

Intervention Type OTHER

Patients will receive a scripted phone call from the research team to remind them to complete the mt-sDNA screening at day 7 and 21.

Portal Message Only

Participants will receive a online patient portal message reminder

Group Type ACTIVE_COMPARATOR

EHR Portal message

Intervention Type OTHER

Patients will receive an EHR patient portal message with a scripted message to remind them to complete the mt-sDNA screening at day 7 and 21.

Interventions

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IVR Reminder

Participants will receive an interactive voice reminder (IVR) to complete mt-sDNA screening at day 7 and 21.

Intervention Type OTHER

Phone call from research team

Patients will receive a scripted phone call from the research team to remind them to complete the mt-sDNA screening at day 7 and 21.

Intervention Type OTHER

EHR Portal message

Patients will receive an EHR patient portal message with a scripted message to remind them to complete the mt-sDNA screening at day 7 and 21.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Chyke A. Doubeni

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chyke Doubeni, MBBS, MPH

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

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20-012010

Identifier Type: -

Identifier Source: org_study_id