Colorectal (Colon or Rectal) CancerNCT04831827
Promoting Equity for Cancer Screening and Follow-up
A study testing IVR Reminder, Phone call from research team and EHR Portal message in people with Colorectal (Colon or Rectal) Cancer, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal (Colon or Rectal) Cancer
- What is being tested?
- IVR Reminder, Phone call from research team and EHR Portal message
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Promoting Equity Through Multicomponent Strategies for Cancer Screening and Follow-up (PREMiS)
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.
Read the 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.
- Conditions
- Colorectal (Colon or Rectal) Cancer
- Being tested
- IVR Reminder, Phone call from research team, EHR Portal message
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVR ReminderOther
Participants will receive an interactive voice reminder (IVR) to complete mt-sDNA screening at day 7 and 21.
Phone call from research teamOther
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.
EHR Portal messageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| IVR Reminder | Experimental | Participants will receive an interactive voice reminder Receives: Other: IVR Reminder |
| Personalized Phone Call Reminder | Active comparator | Participants will receive a personalized phone call Receives: Other: Phone call from research team |
| Portal Message Only | Active comparator | Participants will receive a online patient portal message reminder Receives: Other: EHR Portal message |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Completion by 6 months post randomization
Secondary outcomes (1)
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.
Measured: Completion by 6 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start1 Sep 2021 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Why it stopped: Insufficient study resources and change in practice.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal (Colon or Rectal) CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chyke A. Doubeni, Mayo Clinic
- Investigators
- Chyke Doubeni, MBBS, MPH, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04831827
- Sponsor's protocol ID
- 20-012010
- Status last verified
- Oct 2021
- First submitted
- 1 Apr 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Equity Through Multicomponent Strategies for Cancer Screening and Follow-up (PREMiS)
- ClinicalTrials.gov ID
- NCT04831827
- Acronym / sponsor ID
- 20-012010
- Conditions
- Colorectal (Colon or Rectal) Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient study resources and change in practice.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IVR Reminder | Experimental | Other: IVR ReminderParticipants will receive an interactive voice reminder |
| Personalized Phone Call Reminder | Active comparator | Other: Phone call from research teamParticipants will receive a personalized phone call |
| Portal Message Only | Active comparator | Other: EHR Portal messageParticipants will receive a online patient portal message reminder |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVR ReminderParticipants will receive an interactive voice reminder (IVR) to complete mt-sDNA screening at day 7 and 21. | Other | IVR Reminder |
| Phone call from research teamPatients will receive a scripted phone call from the research team to remind them to complete the mt-sDNA screening at day 7 and 21. | Other | Personalized Phone Call Reminder |
| EHR Portal messagePatients 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. | Other | Portal Message Only |
Primary outcome
Primary Endpoint (intention-to-treat)
Time frame: Completion by 6 months post randomization
The completion rate of mt-sDNA among eligible patients. The primary comparison will be the return rate compared across intervention arms.
1 secondary outcome
Secondary Outcome (per protocol analysis)
Time frame: Completion by 6 months post randomization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chyke Doubeni, MBBS, MPH principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVR Reminder, Phone call from research team and EHR Portal message in people with Colorectal (Colon or Rectal) Cancer, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (intention-to-treat) (time frame: Completion by 6 months post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021; AzTrials last refreshed its copy on 6 Nov 2026.