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Promoting Equity for Cancer Screening and Follow-up

19. oktober 2021 opdateret af: Chyke A. Doubeni, Mayo Clinic

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.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic in Rochester

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: IVR Reminder
Participants will receive an interactive voice reminder
Andet: IVR Reminder
Participants will receive an interactive voice reminder (IVR) to complete mt-sDNA screening at day 7 and 21.
Aktiv komparator: Personalized Phone Call Reminder
Participants will receive a personalized phone call
Andet: 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.
Aktiv komparator: Portal Message Only
Participants will receive a online patient portal message reminder
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Primary Endpoint (intention-to-treat)
Tidsramme: 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.
Completion by 6 months post randomization

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Secondary Outcome (per protocol analysis)
Tidsramme: Completion by 6 months post randomization
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.
Completion by 6 months post randomization

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Mayo Clinic

Efterforskere

  • Ledende efterforsker: Chyke Doubeni, MBBS, MPH, Mayo Clinic

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. september 2021

Primær færdiggørelse (Forventet)

1. maj 2023

Studieafslutning (Forventet)

1. maj 2023

Datoer for studieregistrering

Først indsendt

1. april 2021

Først indsendt, der opfyldte QC-kriterier

1. april 2021

Først opslået (Faktiske)

5. april 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. oktober 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. oktober 2021

Sidst verificeret

1. oktober 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20-012010

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kolon- eller rektalkræft

Kliniske forsøg med IVR Reminder

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Guatemala

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner