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NeoplasmsSPARKLE-2NCT07745816

Effectiveness and Implementation of 'Supportive and Palliative Care Review Kit in Locations Everywhere'

A study testing SPARKLE-2 in people with Neoplasms and Palliative Care, run by National Cancer Centre, Singapore at 2 sites in Singapore.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 21 to 120 years
Conditions the study is for
Neoplasms, Palliative Care
What is being tested?
SPARKLE-2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
2 sitesSingapore
Study dates
15 Nov 2026to 31 Mar 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 15Show fewer
  • Enrolled in the SPARKLE-2 RCT, whether randomized to the SPARKLE intervention or usual care group and regardless of fidelity to trial procedures.
  • 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
  • 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

Who cannot join

  • Assessed by the treating physician as unable to complete study procedures
  • Unable to complete patient-reported outcome measures
  • 1. Unable to complete interviews
  • Healthcare professionals that are not providing care for cancer patients.
  • Unable to complete interviews

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Grace Meijuan YANG, MD, MPH, PhD contact

63065844

grace.yang.m.j@singhealth.com.sg

Jess Ng Hiv Choo contact

jess.ng.h.c@nccs.com.sg

Singapore2 sites

  • National Cancer Centre, Singapore

    Singapore, 168583

    Dr Grace Meijuan YANG, MD, MPH, PhD

  • Singapore General Hospital

    Singapore, 169608

    Dr Yi ZHOU, MD, MRCP (UK), MMed

Other trials in Singapore

About this study

Official title: 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.

Read the detailed description

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:

  1. 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.
  2. 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.
  3. 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.
Being tested
SPARKLE-2
Keywords
SPARKLE-2
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPARKLE-2Behavioural

    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.

Study groups in NCT07745816
Study groupRoleWhat they receive
SPARKLE-2 InterventionExperimentalParticipants will receive SPARKLE-2 immediately at bi-weekly interval.
Receives: Behavioral: SPARKLE-2
Usual CareNo interventionParticipants will not receive any study intervention (SPARKLE-2) and will continue to receive their usual care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 weeks.

Secondary outcomes (6)

  1. 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.

    Measured: Every 12 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier.

  2. 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.

    Measured: Every 2 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier.

  3. 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.

    Measured: Baseline, 12 weeks, 18 weeks, 27 weeks, and 48 weeks.

  4. Acute healthcare utilization.

    Frequency of Emergency Department (ED) visits.

    Measured: Baseline until death or end of the study, up to 48 weeks.

  5. Inpatient healthcare utilization and the intervention's impact on inpatient healthcare utilization.

    Number of hospital admissions.

    Measured: Baseline until death or end of the study, up to 48 weeks.

  6. Healthcare expenditure associated with patient care and the economic impact on intervention.

    Total hospital charges.

    Measured: Baseline until death or end of the study, up to 48 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2026
  2. Study start15 Nov 2026 (estimated)
  3. Primary completion31 Mar 2029 (estimated)
  4. Study completion31 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07745816
Sponsor's protocol ID
2026-0459
Acronym
SPARKLE-2
Status last verified
Oct 2026
First submitted
30 Jul 2026
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39046614

  • 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.

    PubMed 40038129

Questions about this trial

What is this clinical trial studying?

A study testing SPARKLE-2 in people with Neoplasms and Palliative Care, run by National Cancer Centre, Singapore at 2 sites in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Grace Meijuan YANG, MD, MPH, PhD (63065844, grace.yang.m.j@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life score measured using the Functional Assessment of Chronic Illness Therapy - Palliative (FACIT-Pal) (time frame: 12 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07745816, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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