Effectiveness and Implementation of 'Supportive and Palliative Care Review Kit in Locations Everywhere' (SPARKLE-2)

July 30, 2026 updated by: National Cancer Centre, Singapore

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Singapore
      • Singapore, Singapore, 169608
        • Singapore General Hospital
        • Contact:
          • Dr Yi ZHOU, MD, MRCP (UK), MMed
      • Singapore, Singapore, 168583
        • National Cancer Centre, Singapore
        • Contact:
          • Dr Grace Meijuan YANG, MD, MPH, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Inclusion criteria for patients:

    1. 21 years old or older
    2. Diagnosed of advanced cancer diagnosis, defined as metastatic 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 informed consent

      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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SPARKLE-2 Intervention
Participants will receive SPARKLE-2 immediately at bi-weekly interval.
Behavioral: SPARKLE-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.
No Intervention: Usual Care
Participants will not receive any study intervention (SPARKLE-2) and will continue to receive their usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life score measured using the Functional Assessment of Chronic Illness Therapy - Palliative (FACIT-Pal)
Time Frame: 12 weeks.
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.
12 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life score measured using the Functional Assessment of Chronic Illness Therapy - Palliative (FACIT-Pal)
Time Frame: Every 12 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier.
The proposed FACIT-Pal assessment schedule is to evaluate longitudinal changes in quality of life over time.
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)
Time Frame: Every 2 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier.
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.
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)
Time Frame: Baseline, 12 weeks, 18 weeks, 27 weeks, and 48 weeks.
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.
Baseline, 12 weeks, 18 weeks, 27 weeks, and 48 weeks.
Acute healthcare utilization.
Time Frame: Baseline until death or end of the study, up to 48 weeks.
Frequency of Emergency Department (ED) visits.
Baseline until death or end of the study, up to 48 weeks.
Inpatient healthcare utilization and the intervention's impact on inpatient healthcare utilization.
Time Frame: Baseline until death or end of the study, up to 48 weeks.
Number of hospital admissions.
Baseline until death or end of the study, up to 48 weeks.
Healthcare expenditure associated with patient care and the economic impact on intervention.
Time Frame: Baseline until death or end of the study, up to 48 weeks.
Total hospital charges.
Baseline until death or end of the study, up to 48 weeks.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appropriateness and feasibility
Time Frame: Up to 48 weeks.
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).
Up to 48 weeks.
Implementation cost
Time Frame: Up to 48 weeks.
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.
Up to 48 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Centre, Singapore

Investigators

  • Study Chair: Grace Meijuan YANG, MD, MPH, PhD, National Cancer Centre, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

July 30, 2026

First Submitted That Met QC Criteria

July 30, 2026

First Posted (Actual)

August 4, 2026

Study Record Updates

Last Update Posted (Actual)

August 4, 2026

Last Update Submitted That Met QC Criteria

July 30, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-0459

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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