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Promoting Equity for Cancer Screening and Follow-up

Primary Purpose

Colorectal (Colon or Rectal) Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IVR Reminder
Phone call from research team
EHR Portal message
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colorectal (Colon or Rectal) Cancer

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

IVR Reminder

Personalized Phone Call Reminder

Portal Message Only

Arm Description

Participants will receive an interactive voice reminder

Participants will receive a personalized phone call

Participants will receive a online patient portal message reminder

Outcomes

Primary Outcome Measures

Primary Endpoint (intention-to-treat)
The completion rate of mt-sDNA among eligible patients. The primary comparison will be the return rate compared across intervention arms.

Secondary Outcome Measures

Secondary Outcome (per protocol analysis)
The completion rate of mt-sDNA among eligible patients. The comparison will be the return rate compared across intervention arms, excluding participants who received an alternative intervention due to not having appropriate portal access.

Full Information

First Posted
April 1, 2021
Last Updated
October 19, 2021
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04831827
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Insufficient study resources and change in practice.
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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): Automated reminder using the EHR patient portal messaging system. Automated reminder using a customized interactive voice response (IVR) system 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal (Colon or Rectal) Cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
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.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IVR Reminder
Arm Type
Experimental
Arm Description
Participants will receive an interactive voice reminder
Arm Title
Personalized Phone Call Reminder
Arm Type
Active Comparator
Arm Description
Participants will receive a personalized phone call
Arm Title
Portal Message Only
Arm Type
Active Comparator
Arm Description
Participants will receive a online patient portal message reminder
Intervention Type
Other
Intervention Name(s)
IVR Reminder
Intervention Description
Participants will receive an interactive voice reminder (IVR) to complete mt-sDNA screening at day 7 and 21.
Intervention Type
Other
Intervention Name(s)
Phone call from research team
Intervention Description
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
Intervention Name(s)
EHR Portal message
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Endpoint (intention-to-treat)
Description
The completion rate of mt-sDNA among eligible patients. The primary comparison will be the return rate compared across intervention arms.
Time Frame
Completion by 6 months post randomization
Secondary Outcome Measure Information:
Title
Secondary Outcome (per protocol analysis)
Description
The completion rate of mt-sDNA among eligible patients. The comparison will be the return rate compared across intervention arms, excluding participants who received an alternative intervention due to not having appropriate portal access.
Time Frame
Completion by 6 months post randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chyke Doubeni, MBBS, MPH
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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Promoting Equity for Cancer Screening and Follow-up

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