NCT07745816

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Aug 2026

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026Mar 2029

First Submitted

Initial submission to the registry

July 30, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2029

Last Updated

August 4, 2026

Status Verified

July 1, 2026

Enrollment Period

2.7 years

First QC Date

July 30, 2026

Last Update Submit

July 30, 2026

Conditions

NeoplasmsPalliative Care

Keywords

SPARKLE-2

Outcome Measures

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.

    12 weeks.

Secondary Outcomes (6)

  • Quality of life score measured using the Functional Assessment of Chronic Illness Therapy - Palliative (FACIT-Pal)

    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)

    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)

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

  • Acute healthcare utilization.

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

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

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

  • +1 more secondary outcomes

Other Outcomes (2)

  • Appropriateness and feasibility

    Up to 48 weeks.

  • Implementation cost

    Up to 48 weeks.

Study Arms (2)

SPARKLE-2 Intervention

EXPERIMENTAL

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

Behavioral: SPARKLE-2

Usual Care

NO INTERVENTION

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

Interventions

SPARKLE-2BEHAVIORAL

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.

SPARKLE-2 Intervention

Eligibility Criteria

Age21 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Cancer Centre, Singapore

Singapore, 168583, Singapore

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

Related Publications (2)

  • 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.

    PMID: 39046614BACKGROUND

  • 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.

    PMID: 40038129BACKGROUND

Related Links

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Grace Meijuan YANG, MD, MPH, PhD

    National Cancer Centre, Singapore

    STUDY CHAIR

Central Study Contacts

Grace Meijuan YANG, MD, MPH, PhD

CONTACT

63065844grace.yang.m.j@singhealth.com.sg

Jess Ng Hiv Choo

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2026

First Posted

August 4, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

March 31, 2029

Last Updated

August 4, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

SG(2)