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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-120
SponsorNational Cancer Centre, Singapore

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Assessed by the treating physician as unable to complete study procedures

Unable to complete patient-reported outcome measures

Healthcare professionals that are not providing care for cancer patients.

Unable to complete interviews

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: SPARKLE-2 InterventionExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

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.

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.

Sponsors and contacts

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