Clinical trial NCT04242251: Novel Palliative Care Model for Advanced Cancer Patients: A Randomized Controlled Trial Study
Official title: Novel Palliative Care Model for Advanced Cancer Patients: A Randomized Controlled Trial Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Palliative Care
Cancer
Health Services Research
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Singapore
First posted: 2020-01-27
Enrollment: 239
Sex: ALL
Minimum age (years): 21
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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

Primary outcomes:
measure: Functional Assessment of Cancer Therapy- General
timeFrame: 16 weeks
Secondary outcomes:
measure: Singapore Caregiver Quality of Life Scale
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
Study officials:
affiliation: Consultant
name: Grace M Yang, MRCP
role: PRINCIPAL_INVESTIGATOR
References: