SPARK Symptom Screening and Feedback to Providers

Study Overview
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Brief Summary
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Supportive care Prioritization, Assessment and Recommendations for Kids (SPARK) is a web-based application which builds upon the Symptom Screening in Pediatrics Tool (SSPedi) and consists of two components: (1) a symptom screening component centered on SSPedi; and (2) a supportive care clinical practice guideline (CPG) component. This proposal is a randomized controlled trial that compares daily completion of SSPedi via SPARK for 5 days with symptom feedback to healthcare providers compared with standard of care

Detailed Description
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Participants will be children with cancer or hematopoietic stem cell transplantation (HSCT) recipients who are 8-18 years of age and who can understand English, and who are expected to be in hospital or in clinic daily for 5 days. This will be a multi-center RCT in which we will randomize children to either undergo daily symptom screening for 5 days with symptom reports provided to the healthcare team or standard of care. The primary outcome will be the self-reported day 5 total SSPedi score (range 0-60; higher worse). Secondary outcomes will be the day 5 self-reported individual symptom, pain and QoL scores, and documentation of symptoms and provision of interventions for symptoms over the 5 day trial. We will enroll 345 participants over 4 years from 7 Canadian centers

Official Title
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A Randomized Controlled Trial of Symptom Screening by Children With Cancer and Feedback to Providers

Conditions
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Pediatric Oncology, Quality of Life

Intervention / Treatment
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* Other: SPARK


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 8 to 18 years of age Diagnosis of cancer or have received or about to receive HSCT Understand English Expected to be in hospital or clinic for 5 day Exclusion Criteria: illness severity cognitive disability visual impairment

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPARK Intervention<br>Participants will complete symptom screening using SPARK once daily on a study-supplied iPad. For inpatients, daily reminders to complete SSPedi will appear on the iPad. Reports will be available to the child at any time. For outpatients, clinical research associates will provide the iPad in person daily and reports may be viewed at those encounters. The intervention is daily symptom screening with provision of reports to the healthcare team. Severe symptoms will result in email alerts. More specifically, SSPedi reports will be printed daily and provided in the patient chart. On days 1 and 3, an alert will be emailed to the physician providing direct medical care if any symptom is a lot or extremely bothersome (score 3 or 4 on 0-4 scale). Reports and alerts will have links to SPARK-housed CPGs. | Other: SPARK<br>* see above<br>|
| No Intervention: Standard of Care Arm<br>Participants randomized to the control arm will not complete daily symptom screening. They will complete SSPedi on days 1 and 5 to obtain the primary outcome. Health care providers will not be notified of their SSPedi scores and no symptom reports or symptom alerts will be generated. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SSPedi (Symptom Screening in Pediatrics) Total Scores | The primary outcome will be the self-reported total SSPedi score on day 5. The total SSPedi score is a validated measure that reflects the total burden of bothersome symptoms experienced. The total score is the sum of each of the 15 items' Likert scores which range from 0 (not at all bothered) to 4 (extremely bothered) to yield a total score that ranges from 0 (no bothersome symptoms) to 60 (worst bothersome symptoms). | Measure will be completed by all participants on day 5±1 day. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported individual SSPedi (Symptom Screening in Pediatrics) symptom | Each of the 15 symptoms included in SSPedi will be secondary outcomes. (0 not bothered at all to 4 extremely bothersome) | Measure will be completed by all participants on day 5±1 day | 
| Faces Pain Scale-Revised | Self-reported pain will be assessed using the Faces Pain Scale-Revised which consists of a series of horizontal faces that depict a neutral facial expression of no pain on the left and worst pain on the right. It has 6 faces and may be scored on a 0 to 10 scale in which higher numbers denote more pain. | Measure will be completed by all participants on day 5±1 day | 
| PedsQL (pediatric Quality of Life) 3.0 Acute Cancer Module | Self-reported QoL will be measured using the PedsQL 3.0 Acute Cancer Module. This measure is a multidimensional instrument that is reliable and valid in children with cancer. It assesses pain and hurt, nausea, procedural anxiety, treatment anxiety, worry, cognitive problems, perceived physical appearance and communication. The self-report 7-day recall version will be used. The problems are rated from 0; never a problem to 4 if it is almost always a problem.Higher scores denote better health. | Measure will be completed by all participants on day 5±1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric Oncology, Randomized Control Trial, Symptom Screening, Quality of Life