NCT04242251

Brief Summary

This is a randomized controlled trial of the 'Supportive and Palliative care Review Kit in Locations Everywhere' (SPARKLE) intervention, an outpatient-based model of early palliative care. The SPARKLE intervention comprises regular symptom monitoring using questionnaires, early identification and prompt treatment of problems identified. Proactive screening for problems facilitates earlier palliative care interventions for advanced cancer patients, whenever needs arise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
239

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
1 year until next milestone

Study Start

First participant enrolled

February 8, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

April 3, 2024

Status Verified

April 1, 2024

Enrollment Period

2.2 years

First QC Date

January 23, 2020

Last Update Submit

April 1, 2024

Conditions

Cancer

Keywords

Palliative CareCancerHealth Services Research

Outcome Measures

Primary Outcomes (1)

  • Functional Assessment of Cancer Therapy- General

    Quality of life is scored on a scale of 0 to 108, with higher scores indicating better outcomes

    16 weeks

Secondary Outcomes (1)

  • Singapore Caregiver Quality of Life Scale

    16 weeks

Study Arms (2)

Usual Care

NO INTERVENTION

Management by primary oncologist. Referral to existing palliative care service initiated by primary oncologist if needed.

SPARKLE intervention group

EXPERIMENTAL

Regular symptom monitoring and treatment of problems identified. Referral to existing palliative care services can also be initiated by the SPARKLE nurse if identified problems require follow up.

Other: SPARKLE Model of care

Interventions

SPARKLE Model of careOTHER

Patients will receive the SPARKLE model of care in addition to usual oncologist-led care. The SPARKLE model will be led by a palliative medicine doctor and administered by nurses and staff without specific nursing or medical training. It utilizes a stepped care approach where all patients will initially have low-intensity model focused on weekly symptom monitoring through a patient-reported questionnaire. If any problems are identified, then patients step up to a higher-intensity care model where a nurse will conduct a phone assessment of the symptom problems. If the presence of symptoms is confirmed, patients step up again to an even higher-intensity care model where treatment of symptoms will be initiated by the SPARKLE nurse, depending on the severity of the problems. If the symptoms are not fully resolved, the patients will then step up to the highest-intensity care model which is an existing palliative care service- either palliative care outpatient clinic or home hospice.

SPARKLE intervention group

Eligibility Criteria

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

You may qualify if:

  • Adult aged 21 and above
  • Stage 4 solid tumor

You may not qualify if:

  • Unable to complete patient-reported outcome measures
  • Already under the care of an existing palliative care service
  • \- Adult aged 21 and above
  • Unable to complete Singapore Caregiver Quality of Life Scale questionnaire
  • Employed caregiver to patient participants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Centre Singapore

Singapore, 169610, Singapore

Location

Related Publications (1)

  • 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: 40038129DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Grace M Yang, MRCP

    Consultant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The person administering the patient reported outcome measures will be blinded to the participant's allocation to study arms.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2020

First Posted

January 27, 2020

Study Start

February 8, 2021

Primary Completion

April 30, 2023

Study Completion

January 31, 2024

Last Updated

April 3, 2024

Record last verified: 2024-04

Locations

SG(1)