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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Grace Meijuan YANG, MD, MPH, PhD
- Número de teléfono: 63065844
- Correo electrónico: grace.yang.m.j@singhealth.com.sg
Copia de seguridad de contactos de estudio
- Nombre: Jess Ng Hiv Choo
- Correo electrónico: jess.ng.h.c@nccs.com.sg
Ubicaciones de estudio
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Singapore, Singapur, 169608
- Singapore General Hospital
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Contacto:
- Dr Yi ZHOU, MD, MRCP (UK), MMed
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Singapore, Singapur, 168583
- National Cancer Centre, Singapore
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Contacto:
- Dr Grace Meijuan YANG, MD, MPH, PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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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Sin intervención: Usual Care
Participants will not receive any study intervention (SPARKLE-2) and will continue to receive their usual care.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Quality of life score measured using the Functional Assessment of Chronic Illness Therapy - Palliative (FACIT-Pal)
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Quality of life score measured using the Functional Assessment of Chronic Illness Therapy - Palliative (FACIT-Pal)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Appropriateness and feasibility
Periodo de tiempo: 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
Periodo de tiempo: 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
- Silla de estudio: Grace Meijuan YANG, MD, MPH, PhD, National Cancer Centre, Singapore
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Enlaces Útiles
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Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-0459
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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