Novel Palliative Care Model for Advanced Cancer Patients: A Randomized Controlled Trial Study (SPARKLE2)
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|ClinicalTrials.gov Identifier: NCT04242251|
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : May 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Other: SPARKLE Model of care||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The person administering the patient reported outcome measures will be blinded to the participant's allocation to study arms.|
|Primary Purpose:||Supportive Care|
|Official Title:||Novel Palliative Care Model for Advanced Cancer Patients: A Randomized Controlled Trial Study|
|Estimated Study Start Date :||July 1, 2020|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2021|
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.
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242251
|Contact: Grace M Yang, MRCP||+65 firstname.lastname@example.org|
|National Cancer Centre Singapore|
|Singapore, Singapore, 169610|
|Contact: Grace M Yang, MRCP email@example.com|
|Principal Investigator: Grace M Yang, MRCP|
|Principal Investigator:||Grace M Yang, MRCP||Consultant|