Novel Palliative Care Model for Advanced Cancer Patients: A Randomized Controlled Trial Study (SPARKLE2)

April 1, 2024 updated by: National Cancer Centre, Singapore
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized controlled trial to compare clinical outcomes between advanced cancer patients receiving and not receiving care from the SPARKLE care model, in addition to current oncologic-led palliative care model. The hypothesis is that the SPARKLE care model results in a) improved quality of life of both advanced cancer patients and their caregivers, and b) reduced acute healthcare utilization and costs by these patients.

Primary Study Aim: To determine the incremental effect of SPARKLE in addition to usual oncologist-led care on quality of life of advanced cancer patients. Patients' quality of life will be measured at baseline before randomization and 16 weeks after randomization using the Functional Assessment of Cancer Therapy - General (FACT-G).

Secondary Study Aim 1: To determine the incremental effect of SPARKLE in addition to usual oncologist-led care on caregivers' quality of life. Caregiver quality of life will be measured at baseline before randomization and 16 weeks after randomization using the Singapore Caregiver Quality of Life Scale (SCQOLS), which was validated among caregivers of advanced cancer patients in Singapore.17 The PI was part of the team, led by the applicant's mentor, that developed the SCQOLS.

Secondary Study Aim 2: To determine the effect of SPARKLE in addition to usual oncologist-led care on healthcare utilization and total healthcare costs, including the costs of delivering SPARKLE, from randomization until death. Healthcare utilization and cost data will be extracted from medical and billing data. SPARKLE costs will be captured prospectively using an Activity Based Costing Approach. The study hypothesis is that per capita healthcare costs will be lower in the SPARKLE model due to fewer admissions and shorter hospital lengths of stay when admitted.

A prospective randomized controlled trial design will be used to test the effectiveness of the SPARKLE model. The recruitment target is 240 patients with advanced cancers, defined as stage 4 solid tumors including lung, colorectal, nasopharyngeal and pancreatic cancers. Eligible participants are randomized to usual care or SPARKLE intervention group using randomized permuted blocks method generated by an independent statistician, with block size kept unknown to the clinical investigators/site personnel. A total of 240 caregivers will be recruited.

The study will take place in the National Cancer Centre of Singapore (NCCS).

Study Type

Interventional

Enrollment (Actual)

239

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 169610
        • National Cancer Centre Singapore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Patient participants Inclusion Criteria:

  • Adult aged 21 and above
  • Stage 4 solid tumor

Patient participants Exclusion Criteria:

  • Unable to complete patient-reported outcome measures
  • Already under the care of an existing palliative care service

Caregiver participants Inclusion Criteria:

- Adult aged 21 and above

Caregiver participants Exclusion Criteria:

  • Unable to complete Singapore Caregiver Quality of Life Scale questionnaire
  • Employed caregiver to patient participants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Management by primary oncologist. Referral to existing palliative care service initiated by primary oncologist if needed.
Experimental: SPARKLE intervention group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Assessment of Cancer Therapy- General
Time Frame: 16 weeks
Quality of life is scored on a scale of 0 to 108, with higher scores indicating better outcomes
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Singapore Caregiver Quality of Life Scale
Time Frame: 16 weeks
Caregiver quality of life is scored on a scale of 0 to 100, with higher scores indicating better outcomes
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Centre, Singapore

Collaborators

Ministry of Health, Singapore

Investigators

  • Principal Investigator: Grace M Yang, MRCP, Consultant

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2021

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

January 23, 2020

First Submitted That Met QC Criteria

January 23, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2019/2963

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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