ClinicalTrials.gg
Not yet recruitingNCT07745816SPARKLE-2Updated Oct 2, 2026

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

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 2026-10-02.

Sponsored by National Cancer Centre, Singapore · Not applicable, Interventional, and Health services research

Updated Oct 2, 2026Start date movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
21 Years to 120 Years
Sex
All
01

Study 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.

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.
02

Conditions studied

  • Neoplasms
  • Palliative Care

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Keywords

  • SPARKLE-2
03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's planned enrollment of 300 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

National Cancer Centre, Singapore is the lead sponsor of 117 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Inclusion criteria for patients:

    1. 21 years old or older
    2. Diagnosed of advanced cancer diagnosis, defined as or recurrent/ progressive Stage III/IV solid tumour
    3. Has an unplanned hospital admission and expected to be discharged home
    4. Able to speak English or Mandarin Chinese or Malay
    5. Able to provide

      Additional inclusion criteria for patient participants of semi-structured interviews are:

    6. 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:

    1. 21 years old or older
    2. 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
    3. Able to speak English or Mandarin Chinese or Malay
    4. Able to provide informed consent
  • Inclusion criteria for healthcare providers:

    1. 21 years old or older
    2. Healthcare professional who is involved in the clinical care of patients with advanced cancer for at least 50% of their work hours
    3. Able to provide informed consent
    4. Involved in the processes of the SPARKLE-2

Exclusion Criteria:

  • Exclusion criteria for patients:

    1. Assessed by the treating physician as unable to complete study procedures
    2. Unable to complete patient-reported outcome measures
  • Exclusion criteria for caregivers:

    1. Unable to complete interviews

  • Exclusion criteria for healthcare providers:

    1. Healthcare professionals that are not providing care for cancer patients.
    2. Unable to complete interviews
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    SPARKLE-2 Intervention

    Participants will receive SPARKLE-2 immediately at bi-weekly interval.

    Behavioral: SPARKLE-2

  • No intervention
    Usual Care

    Participants will not receive any study intervention (SPARKLE-2) and will continue to receive their usual care.

Interventions

  • BehavioralSPARKLE-2

    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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 12 weeks.

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Baseline, 12 weeks, 18 weeks, 27 weeks, and 48 weeks.

  4. Acute healthcare utilization.

    Frequency of Emergency Department (ED) visits.

    Time frame: 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.

    Time frame: 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.

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

Other outcomes

  1. 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.

  2. 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.

07

Study locations

2 sites
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Mar 2029, 28 months later.

Of 1,981 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's planned 28 months is close to that.

Counting every sponsor, half of 2,056 studies reached it within 29 months; a quarter within 13 and three quarters within 52.

Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Nov 2026, on Oct 2, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jul 30, 2026
First posted
Aug 4, 2026
StartEst.
Nov 15, 2026was Aug 2026
Primary completionEst.
Mar 31, 2029
CompletionEst.
Mar 31, 2029
Last update
Oct 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Aug 1, 2026→Nov 15, 2026
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Start date Aug 1, 2026→Nov 15, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07745816
Responsible party
Sponsor
First posted
Aug 4, 2026
Start date
Nov 15, 2026 (estimated)
Primary completion
Mar 31, 2029 (estimated)
Completion
Mar 31, 2029 (estimated)
Last update
Oct 2, 2026

Study contacts

Grace Meijuan YANG, MD, MPH, PhD
Contact
grace.yang.m.j@singhealth.com.sg
63065844
Jess Ng Hiv Choo
Contact
jess.ng.h.c@nccs.com.sg
Grace Meijuan YANG, MD, MPH, PhD
study chair · National Cancer Centre, Singapore

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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