- ICH GCP
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- Essai clinique NCT02815436
Effectiveness of Tel and SMS Reminder on Compliance With CRC Screening
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).
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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).
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
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Hong Kong, Hong Kong
- The Chinese University of Hong Kong
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Dépistage
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Telephone reminder
subjects in this arm will receive a telephone reminder
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a personal, interactive telephone reminder by a centre colleague to remind return to the centre for taking faecal tubes for screening
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Comparateur actif: SMS reminder
Subjects in this arm will receive a SMS reminder
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a one-way, SMS message sent from the centre to the screening participant's mobile phone
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Aucune intervention: No reminder
usual care, where no additional intervention will be offered
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Rate of completion of FOBT in the year of receiving the interventions/control
Délai: 1 year
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1 year
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Rate of return of FOBT tubes in the year of receiving the interventions/control
Délai: 1 year
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1 year
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Martin Wong, MD, CUHK
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Tel Compliance Study_Protocol
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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