Promoting Equity for Cancer Screening and Follow-up

NCT04831827 | Withdrawn

• 1 other identifier: 20-012010
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal (Colon or Rectal) Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Completion by 6 months post randomization

Secondary Outcomes (1)

• Secondary Outcome (per protocol analysis)

  Completion by 6 months post randomization

Study Arms (3)

IVR Reminder

EXPERIMENTAL

Participants will receive an interactive voice reminder

Other: IVR Reminder

Personalized Phone Call Reminder

ACTIVE COMPARATOR

Participants will receive a personalized phone call

Other: Phone call from research team

Portal Message Only

ACTIVE COMPARATOR

Participants will receive a online patient portal message reminder

Other: EHR Portal message

Interventions

IVR Reminder OTHER

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

IVR Reminder

Phone call from research team 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.

Personalized Phone Call Reminder

EHR Portal message 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.

Portal Message Only

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Chyke Doubeni, MBBS, MPH

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 5, 2021
• Study Start: September 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)