Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-31 @ 8:28 PM
Study NCT ID:
NCT04242251
Status:
COMPLETED
Last Update Posted:
2024-04-03
First Post:
2020-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Palliative Care Model for Advanced Cancer Patients: A Randomized Controlled Trial Study
Sponsor:
National Cancer Centre, Singapore
Organization:
Study Overview
Official Title:
Novel Palliative Care Model for Advanced Cancer Patients: A Randomized Controlled Trial Study
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPARKLE2
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.
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: