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Effectiveness of Tel and SMS Reminder on Compliance With CRC Screening

16. juli 2018 opdateret af: Martin Chi Sang Wong, Chinese University of Hong Kong

The Effectiveness of Telephone Reminders and SMS Messages on Compliance With Colorectal Cancer Screening: An Open-label, Randomized Controlled Trial

Colorectal cancer (CRC) is one of the major global health challenges. CRC is currently the third most common cancer in men and the second common in women worldwide, accounting for approximately 10% of all cancers.

Randomized controlled studies have shown that CRC screening using Faecal Occult Blood Testing (FOBT) is effective in reducing cancer mortality by 15-33%. Since yearly testing is recommended to maintain programmatic effectiveness, longitudinal adherence is a critical component of FOBT-based screening programs. The investigators previous study conducted in Hong Kong showed that the rate of compliance with CRC screening was declining since the first year of enrolment.

Nevertheless, it remains unknown whether interventions based on reminder systems could effectively enhance longitudinal compliance with FOBT, especially among those who have already enrolled in a CRC screening programme. Current evidence does not adequately compare whether interactive or one-way reminder messages are superior to usual care (i.e. no reminders).

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Colorectal cancer (CRC) is one of the major global health challenges. CRC is currently the third most common cancer in men and the second common in women worldwide, accounting for approximately 10% of all cancers. It leads to 8% of all cancer mortality in the world and it is the fourth most common cause of cancer deaths. There were 4,563 new cases and 3,893 new deaths in Hong Kong in 2012, while 47.4% of the new cases were diagnosed at stage III or above. In the past decades the Asia Pacific countries like China, South Korea, Japan, and Singapore have witnessed a two to three-fold rise in incidence, gradually catching up the figures in Western countries. The direct medical cost for the care of colorectal neoplasia was estimated US$45,115 for stage IV CRC in the initial year of care, bringing a substantial, global public health burden to the healthcare systems.

Randomized controlled studies have shown that CRC screening using Faecal Occult Blood Testing (FOBT) is effective in reducing cancer mortality by 15-33%. FOBT as a quick office-based procedure has the advantages of being non-invasive, inexpensive, acceptable, feasible, patient-friendly and devoid of needs for bowel preparation. A 25% relative risk reduction in CRC mortality was found for those attending at least one round of FOBT screening, according to a systematic review conducted in 2007. Guidelines from the US Preventive Services Task Force, the European Nations, the Asia Pacific Consensus statements and other authorities recommended FOBT as one of the first-line screening modalities, especially in resource-limited regions. Since yearly testing is recommended to maintain programmatic effectiveness, longitudinal adherence is a critical component of FOBT-based screening programs. The investigators previous study conducted in Hong Kong showed that the rate of compliance with CRC screening was declining since the first year of enrolment.

Nevertheless, it remains unknown whether interventions based on reminder systems could effectively enhance longitudinal compliance with FOBT, especially among those who have already enrolled in a CRC screening programme. Current evidence does not adequately compare whether interactive or one-way reminder messages are superior to usual care (i.e. no reminders).

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

600

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

      • Hong Kong, Hong Kong
        • The Chinese University of Hong Kong

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

40 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Subjects who joined the bowel cancer screening programme in the CUHK JC Bowel Cancer Education Centre who are expected to follow-up and return to the centre for annual Fecal Occult Blood Test.

Exclusion Criteria:

  • Subjects who have medical conditions rendering them unable to understand telephone or SMS messages.
  • Subjects without mobile phone

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Screening
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Telephone reminder
subjects in this arm will receive a telephone reminder
a personal, interactive telephone reminder by a centre colleague to remind return to the centre for taking faecal tubes for screening
Aktiv komparator: SMS reminder
Subjects in this arm will receive a SMS reminder
a one-way, SMS message sent from the centre to the screening participant's mobile phone
Ingen indgriben: No reminder
usual care, where no additional intervention will be offered

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Rate of completion of FOBT in the year of receiving the interventions/control
Tidsramme: 1 year
1 year

Sekundære resultatmål

Resultatmål
Tidsramme
Rate of return of FOBT tubes in the year of receiving the interventions/control
Tidsramme: 1 year
1 year

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Martin Wong, MD, CUHK

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

1. april 2016

Primær færdiggørelse (Faktiske)

1. december 2017

Studieafslutning (Faktiske)

1. december 2017

Datoer for studieregistrering

Først indsendt

24. juni 2016

Først indsendt, der opfyldte QC-kriterier

27. juni 2016

Først opslået (Skøn)

28. juni 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. juli 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juli 2018

Sidst verificeret

1. juli 2018

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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 Kolorektal cancer

Kliniske forsøg med Telephone reminder

3
Abonner