Clinical trial · Interventional
Effectiveness and Implementation of 'Supportive and Palliative Care Review Kit in Locations Everywhere'
Effectiveness and Implementation of 'Supportive and Palliative cAre Review Kit in Locations Everywhere' (SPARKLE-2) - A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Palliative Care | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SPARKLE-2 | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SPARKLE-2 Intervention
- description
- Participants will receive SPARKLE-2 immediately at bi-weekly interval.
- interventionNames
- Behavioral: SPARKLE-2
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- Participants will not receive any study intervention (SPARKLE-2) and will continue to receive their usual care.
Primary outcomes (1)
- measure
- Quality of life score measured using the Functional Assessment of Chronic Illness Therapy - Palliative (FACIT-Pal)
- timeFrame
- 12 weeks.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 interviewsReferences
Publications (2)
- BACKGROUNDEllis 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. PMID 39046614
- BACKGROUNDYang 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. PMID 40038129