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NCT Number: NCT07745816

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

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.

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Key information

Conditions

Neoplasms Palliative Care

Age range

21 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Centre, Singapore, Singapore

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Unable to complete interviews
  • Exclusion criteria for healthcare providers:
  • Healthcare professionals that are not providing care for cancer patients.
  • Unable to complete interviews

Treatment and study plan

SPARKLE-2

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Acute healthcare utilization.

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

    Frequency of Emergency Department (ED) visits.

  5. 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.

  6. 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.

Other outcomes

  1. 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).

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Grace Meijuan YANG, MD, MPH, PhD

CONTACT

[email protected]

63065844

Jess Ng Hiv Choo

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

National Cancer Centre, Singapore

Other

Registry information

Official study title

Effectiveness and Implementation of 'Supportive and Palliative cAre Review Kit in Locations Everywhere' (SPARKLE-2) - A Randomized Controlled Trial

Acronym: SPARKLE-2

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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