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

Cancer Clinical Trial

— SPARKLE2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04242251
• Other study ID #: 2019/2963
• Status: Completed
• Phase: N/A
• Start date: February 8, 2021
• Est. completion date: January 31, 2024

Study information

• Verified date: April 2024
• Source: National Cancer Centre, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: January 31, 2024
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
Singapore	National Cancer Centre Singapore	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Centre, Singapore	Ministry of Health, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Singapore Caregiver Quality of Life Scale	Caregiver quality of life is scored on a scale of 0 to 100, with higher scores indicating better outcomes	16 weeks