Effectiveness and Implementation of 'Supportive and Palliative Care Review Kit in Locations Everywhere' (SPARKLE-2)
Effectiveness and Implementation of 'Supportive and Palliative cAre Review Kit in Locations Everywhere' (SPARKLE-2) - A Randomized Controlled Trial
Advanced cancer patients often experience significant physical and emotional symptoms, which can lead to frequent hospital visits and reduced quality of life. Although palliative care can help manage these symptoms and improve well-being, it is often introduced too late.
A proactive symptom monitoring model, SPARKLE-2 aims to identify patients who need palliative care earlier by regularly checking their symptoms using a simple questionnaire. Patients with concerned symptoms will receive timely support from the palliative care team, with the goal of improving their quality of life, reducing unnecessary hospital admissions, and helping more patients receive care in the community rather than in hospital. In the earlier SPARKLE-1 study, it showed the improvement of patients' physical wellbeing. SPARKLE-2 seeks to test the effectiveness among advanced cancer patients with unplanned hospital visits while simultaneously collecting data on real-world implementation.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
To evaluate the effectiveness of SPARKLE-2, we will conduct randomized controlled trial comparing clinical outcomes at 3 months between patients receiving usual care and intervention. For longer-term impact of palliative care, we will also measure patient outcomes at 6, 9, and 12 months. To evaluate ways to improve implementation, the Consolidated Framework for Implementation Research (CFIR) will be used to systematically identify processes that influence implementation outcomes.
The specific aims and hypotheses of this mixed methods study are:
- Assess the effectiveness of SPARKLE-2 on health-related quality of life and healthcare utilization among patients with advanced cancer. We hypothesize that the SPARKLE-2 group compared to the usual care group participants will have better health-related quality of life, better health status, earlier palliative care utilisation, and less acute healthcare utilisation.
- Assess implementation processes of SPARKLE-2. We will assess acceptability, appropriateness, and feasibility through a structured survey among healthcare providers. Also, we will assess fidelity through completion rate of IPOS screening questionnaires and compliance with clinical response pathways. Implementation costs will be captured from the healthcare system's perspective prospectively using an activity-based costing approach.
- Assess contexts and mechanisms that bring about SPARKLE-2 outcomes. We will interview patients, caregivers and healthcare providers who were involved in SPARKLE-2 to explore their perspectives on factors, including facilitators and barriers, that bring about intervention effects.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Grace Meijuan YANG, MD, MPH, PhD
- Número de telefone: 63065844
- E-mail: grace.yang.m.j@singhealth.com.sg
Estude backup de contato
- Nome: Jess Ng Hiv Choo
- E-mail: jess.ng.h.c@nccs.com.sg
Locais de estudo
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Singapore, Cingapura, 169608
- Singapore General Hospital
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Contato:
- Dr Yi ZHOU, MD, MRCP (UK), MMed
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Singapore, Cingapura, 168583
- National Cancer Centre, Singapore
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Contato:
- Dr Grace Meijuan YANG, MD, MPH, PhD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
Inclusion criteria for patients:
- 21 years old or older
- Diagnosed of advanced cancer diagnosis, defined as metastatic or recurrent/ progressive Stage III/IV solid tumour
- Has an unplanned hospital admission and expected to be discharged home
- Able to speak English or Mandarin Chinese or Malay
Able to provide informed consent
Additional inclusion criteria for patient participants of semi-structured interviews are:
- Enrolled in the SPARKLE-2 RCT, whether randomized to the SPARKLE intervention or usual care group and regardless of fidelity to trial procedures.
Inclusion criteria for caregivers:
- 21 years old or older
- Self-endorsing or identified by an enrolled patient as a spouse/partner, relative or friend who knows them well and who provides support due to their cancer
- Able to speak English or Mandarin Chinese or Malay
- Able to provide informed consent
Inclusion criteria for healthcare providers:
- 21 years old or older
- Healthcare professional who is involved in the clinical care of patients with advanced cancer for at least 50% of their work hours
- Able to provide informed consent
- Involved in the processes of the SPARKLE-2
Exclusion Criteria:
Exclusion criteria for patients:
- Assessed by the treating physician as unable to complete study procedures
- Unable to complete patient-reported outcome measures
Exclusion criteria for caregivers:
1. Unable to complete interviews
Exclusion criteria for healthcare providers:
- Healthcare professionals that are not providing care for cancer patients.
- Unable to complete interviews
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: SPARKLE-2 Intervention
Participants will receive SPARKLE-2 immediately at bi-weekly interval.
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Patients will receive a Short Message Service (SMS) text on their phone every 2 weeks, inviting them to complete a self-reported online six-item Integrated Palliative care Outcome Scale (IPOS) questionnaire over a period of 12 months. If a patient records higher scores on any IPOS symptom domains, a programme coordinator will then make a phone call to the patient for further assessment of symptoms and concerns identified. If indicated, the programme coordinator would then initiate management of the symptoms and concerns according to structured clinical management protocols. |
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Sem intervenção: Usual Care
Participants will not receive any study intervention (SPARKLE-2) and will continue to receive their usual care.
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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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Quality of life score measured using the Functional Assessment of Chronic Illness Therapy - Palliative (FACIT-Pal)
Prazo: 12 weeks.
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FACIT-Pal is a 46-item measure with a quality-of-life scale (4 domains: physical, emotional, social, and functional well-being) and a palliative care subscale.
It has demonstrated internal consistency, reliability and validity for persons with advanced cancer.
Quality of life is scored on a scale of 0 to 184, with higher scores indicating better outcomes.
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12 weeks.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Quality of life score measured using the Functional Assessment of Chronic Illness Therapy - Palliative (FACIT-Pal)
Prazo: Every 12 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier.
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The proposed FACIT-Pal assessment schedule is to evaluate longitudinal changes in quality of life over time.
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Every 12 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier.
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Palliative care concerns measured using the Integrated Palliative Care Outcomes Scale (IPOS)
Prazo: Every 2 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier.
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IPOS is a brief measure of palliative care problems, covering physical and psychological symptoms, social and spiritual issues, communication, information needs, and practical concerns.
Each item is rated on a Likert scale of 0 to 4. Higher scores indicate that symptoms and concerns affect the person more.
IPOS has been translated to Chinese and validated in Singapore.
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Every 2 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier.
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Health states measured using the EuroQOL Group 5-Dimension Health-related Quality of Life Measurement (EQ-5D-5L)
Prazo: Baseline, 12 weeks, 18 weeks, 27 weeks, and 48 weeks.
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EQ-5D-5L contains a 5-item descriptive system measuring 5 dimensions: mobility, self-care, usual activities, pain/ discomfort, anxiety/ depression; a visual analogue scale measuring overall health status.
The tool has been validated in Singapore.
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Baseline, 12 weeks, 18 weeks, 27 weeks, and 48 weeks.
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Acute healthcare utilization.
Prazo: Baseline until death or end of the study, up to 48 weeks.
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Frequency of Emergency Department (ED) visits.
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Baseline until death or end of the study, up to 48 weeks.
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Inpatient healthcare utilization and the intervention's impact on inpatient healthcare utilization.
Prazo: Baseline until death or end of the study, up to 48 weeks.
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Number of hospital admissions.
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Baseline until death or end of the study, up to 48 weeks.
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Healthcare expenditure associated with patient care and the economic impact on intervention.
Prazo: Baseline until death or end of the study, up to 48 weeks.
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Total hospital charges.
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Baseline until death or end of the study, up to 48 weeks.
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Appropriateness and feasibility
Prazo: Up to 48 weeks.
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To explore perspectives on factors, including facilitators and barriers among patients, caregivers and healthcare workers.
Semi-structured interviews conducted using an interview guide developed based on the Consolidated Framework for Implementation Research (CFIR).
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Up to 48 weeks.
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Implementation cost
Prazo: Up to 48 weeks.
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Process maps and project records detailing key intervention activities to elucidate cost of involved personnel and resources through a time-tracking system and an activity-based costing approach.
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Up to 48 weeks.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Grace Meijuan YANG, MD, MPH, PhD, National Cancer Centre, Singapore
Publicações e links úteis
Publicações Gerais
- Ellis KR, Furgal A, Wayas F, Contreras A, Jones C, Perez S, Raji D, Smith M, Vincent C, Song L, Northouse L, Langford AT. Symptom burden and quality of life among patient and family caregiver dyads in advanced cancer. Qual Life Res. 2024 Nov;33(11):3027-3038. doi: 10.1007/s11136-024-03743-8. Epub 2024 Jul 24.
- Yang GM, Ke Y, Ng XH, Neo PSH, Cheung YB. Proactive symptom monitoring to initiate timely palliative care for patients with advanced cancer: a randomized controlled trial. Support Care Cancer. 2025 Mar 5;33(3):249. doi: 10.1007/s00520-025-09311-1.
Links úteis
Datas de registro do estudo
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Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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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
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Outros números de identificação do estudo
- 2026-0459
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