- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Singapore, Cingapura
- National University Hospital Singapore
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Triagem
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Outro: 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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Experimental: 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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Comparison of Screen-Adherent Participants Between Arm 1 and Arm 2
Prazo: 24 months post-intervention
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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
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Proportion of participants with BMI in the healthy range
Prazo: 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
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24 months post-intervention
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Proportion of participants achieving a daily goal of 10,000 steps
Prazo: 24 months post-intervention
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Proportion of participants (in %) achieving a daily goal of 10,000 steps in Arm 1 vs Arm 2
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24 months post-intervention
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Proportion of participants with recommended moderate-intensity aerobic activity
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Soo-Chin Lee, MBBS, MRCP, National University Hospital, Singapore
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 2024-4448
Plano para dados de participantes individuais (IPD)
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Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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