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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
Sponsor:
Collaborator:
Ministry of Health, Singapore
Information provided by (Responsible Party):
National Cancer Centre, Singapore

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.

Condition or disease Intervention/treatment Phase
Cancer Other: SPARKLE Model of care Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242251


Contacts
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Contact: Grace M Yang, MRCP +65 64368293 grace.yang.m.j@singhealth.com.sg

Locations
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Singapore
National Cancer Centre Singapore
Singapore, Singapore, 169610
Contact: Grace M Yang, MRCP       grace.yang.m.j@singhealth.com.sg   
Principal Investigator: Grace M Yang, MRCP         
Sponsors and Collaborators
National Cancer Centre, Singapore
Ministry of Health, Singapore
Investigators
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Principal Investigator: Grace M Yang, MRCP Consultant
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Responsible Party: National Cancer Centre, Singapore
ClinicalTrials.gov Identifier: NCT04242251    
Other Study ID Numbers: 2019/2963
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Cancer Centre, Singapore:
Palliative Care
Cancer
Health Services Research