- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07725328
Pragmatic Mobile Health Trial to Promote Cancer Screening and Healthy Behaviors (mHEALTH)
Pragmatic Randomized Trial Using Mobile Health (mHealth) Technology to Change Cancer Screening Behavior and Promote Healthier Lifestyle
Cancer is the leading cause of death in Singapore, but many people who are eligible for breast, cervical, and colorectal cancer screening do not get screened on time. Many adults also have chronic health conditions such as high blood pressure, diabetes, high cholesterol, and obesity, which can often be reduced through healthier lifestyle habits. Although reminders for screening are available, they may not be enough to encourage long-term healthy behaviours.
This study will evaluate whether regular health messages delivered through a mobile health (mHealth) platform can help improve cancer screening participation and promote healthier lifestyles among Singaporean women aged 50-69 years. Participants will be randomly assigned to one of two groups. The control group will receive standard cancer screening reminders every six months. The intervention group will receive monthly evidence-based health messages, including information on cancer screening, healthy eating, physical activity, and other healthy lifestyle behaviours, delivered through the NUHS App (or a similar mobile platform) or SMS.
The study will compare whether more frequent and engaging health messages lead to higher participation in recommended cancer screening, greater engagement with the digital platform, and healthier lifestyle behaviours compared with standard reminders. The findings may help identify an effective and scalable digital approach to support cancer prevention and healthy ageing across Singapore.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Cancer remains the leading cause of death in Singapore despite the availability of national screening programmes for breast, cervical, and colorectal cancers. Participation in recommended cancer screening remains below desired levels, while chronic diseases associated with unhealthy lifestyle behaviours continue to increase. Existing approaches to promoting preventive health often rely on infrequent reminders and may be insufficient to support sustained behavioural change.
Singapore's widespread use of smartphones and digital health platforms provides an opportunity to deliver scalable mobile health (mHealth) interventions. This pragmatic randomized trial will evaluate whether regular delivery of evidence-based health messages through the NUHS App (or a similar mobile platform) or SMS can improve participation in recommended cancer screening and promote healthier lifestyle behaviours among Singaporean women aged 50-69 years.
Participants will receive either standard screening reminders or a more intensive programme of health messages covering cancer screening, healthy diet, physical activity, weight management, and other preventive health topics. The study will evaluate whether a sustained digital engagement strategy is more effective than standard reminders in encouraging long-term health behaviour change.
Because the intervention is delivered using existing healthcare digital infrastructure, the findings will inform whether this approach can be implemented at scale to improve cancer prevention and support healthy ageing in Singapore.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
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Singapore, Singapour
- National University Hospital Singapore
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- If using app for message delivery: Registered NUHS App users or HealthHub App users OR if using SMS for message delivery: Participants must have a mobile number recorded in electronic medical records (EPIC).
- Female
- Singapore citizen
- Aged 50-69 years
- With or without prior diagnosis of cancer
Exclusion Criteria:
- Participants unable to provide informed consent and take surveys, such as those with cognitive impairments or severe mental health conditions.
- Participants with terminal illness or serious comorbidities that preclude them from participating in preventive health programs.
- Pregnant women: Given the target age group (50-69 years), the prevalence of pregnancy is expected to be extremely low.
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 |
|---|---|
|
Autre: Standard Messaging Arm (Arm 1)
Participants receive standard cancer screening reminders through the NUHS App or SMS according to usual practice.
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Participants receive two standard health messages through PN via the NUHS app or similar platforms OR via SMS - one at recruitment and a subsequent reminder message after 6 months.
The content will include general population cancer screening guidelines (breast, colorectal, and cervical cancers) and information pertaining to healthy lifestyle practices (including maintaining a healthy BMI, balanced diet, and sufficient exercise).
|
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Expérimental: Intensive Engagement Arm (Arm 2)
Participants receive regular evidence-based health messages through the NUHS App or SMS to promote cancer screening and healthy lifestyle.
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Participants will receive the standard bi-annual health messages as in Arm 1, supplemented with additional monthly messages through PN via the app OR via SMS, that provide comprehensive information on general population cancer screening guidelines, healthy lifestyle practices, motivational health messages, video links, and details about relevant events over a period of 12 months.
In addition to the monthly messages, participants will be invited to attend up to 12 webinars (on women's health/screening/nutrition/lifestyle related topics) and 12 in-person or virtual group events (like simple low-intensity exercise/ walking/ basic yoga/ tai chi/nutritional cooking etc.) over 12 months.
Interested participants may also be asked to join a moderated chatgroup (using Telegram app).
The chatgroup is intended to promote peer support and healthy habit building.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Comparison of Screen-Adherent Participants Between Arm 1 and Arm 2
Délai: 24 months post-intervention
|
Proportion of screen-adherent participants (in %) in Arm-2 versus Arm-1 at 24 months. Non-adherence at baseline is defined as not being fully adherent to screening guidelines for all three cancers (with cervical cancer screening excluded for those not sexually active). Adherence following the intervention is defined as showing at least one improvement in adherence (e.g., previously adherent to only cervical cancer screening, with subsequent adherence to colorectal cancer screening). |
24 months post-intervention
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Proportion of participants with BMI in the healthy range
Délai: 24 months post-intervention
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Proportion of participants (in %) with BMI in the healthy range (18.5-22.9
kg/m2) in Arm 1 vs Arm 2
|
24 months post-intervention
|
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Proportion of participants achieving a daily goal of 10,000 steps
Délai: 24 months post-intervention
|
Proportion of participants (in %) achieving a daily goal of 10,000 steps in Arm 1 vs Arm 2
|
24 months post-intervention
|
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Proportion of participants with recommended moderate-intensity aerobic activity
Délai: 24 months post-intervention
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Proportion of participants (in %) with 150-300 minutes of moderate-intensity aerobic activity in Arm 1 vs Arm 2
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24 months post-intervention
|
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Proportion of participants eating recommended servings of fruits/vegetables daily at 24 months
Délai: 24 months post-intervention
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Proportion of participants eating at least 5 servings of fruits/vegetables daily in Arm 1 vs Arm 2
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24 months post-intervention
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Soo-Chin Lee, MBBS, MRCP, National University Hospital, Singapore
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
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
Mots clés
Autres numéros d'identification d'étude
- 2024-4448
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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