An interventional study of SPARKLE-2 in Neoplasms and Palliative Care, sponsored by National Cancer Centre, Singapore. Not yet recruiting at 2 sites in Singapore. Open to participants aged 21 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by National Cancer Centre, Singapore · Not applicable, Interventional, and Health services research
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.
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:
Inclusion Criteria:
Inclusion criteria for patients:
Able to provide informed consent
Additional inclusion criteria for patient participants of semi-structured interviews are:
Inclusion criteria for caregivers:
Inclusion criteria for healthcare providers:
Exclusion Criteria:
Exclusion criteria for patients:
Exclusion criteria for caregivers:
1. Unable to complete interviews
Exclusion criteria for healthcare providers:
Participants will receive SPARKLE-2 immediately at bi-weekly interval.
Behavioral: SPARKLE-2
Participants will not receive any study intervention (SPARKLE-2) and will continue to receive their usual care.
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.
Quality of life score measured using the Functional Assessment of Chronic Illness Therapy - Palliative (FACIT-Pal)
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.
Time frame: 12 weeks.
Quality of life score measured using the Functional Assessment of Chronic Illness Therapy - Palliative (FACIT-Pal)
The proposed FACIT-Pal assessment schedule is to evaluate longitudinal changes in quality of life over time.
Time frame: Every 12 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier.
Palliative care concerns measured using the Integrated Palliative Care Outcomes Scale (IPOS)
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.
Time frame: Every 2 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier.
Health states measured using the EuroQOL Group 5-Dimension Health-related Quality of Life Measurement (EQ-5D-5L)
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.
Time frame: Baseline, 12 weeks, 18 weeks, 27 weeks, and 48 weeks.
Acute healthcare utilization.
Frequency of Emergency Department (ED) visits.
Time frame: Baseline until death or end of the study, up to 48 weeks.
Inpatient healthcare utilization and the intervention's impact on inpatient healthcare utilization.
Number of hospital admissions.
Time frame: Baseline until death or end of the study, up to 48 weeks.
Healthcare expenditure associated with patient care and the economic impact on intervention.
Total hospital charges.
Time frame: Baseline until death or end of the study, up to 48 weeks.
Appropriateness and feasibility
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).
Time frame: Up to 48 weeks.
Implementation cost
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.
Time frame: Up to 48 weeks.
Plan to share: No
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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National Cancer Centre, Singapore