SPARK Symptom Screening and Feedback to Providers
- Conditions
- Pediatric OncologyQuality of Life
- Interventions
- Other: SPARK
- Registration Number
- NCT03593525
- Lead Sponsor
- The Hospital for Sick Children
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 345
- 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
- illness severity
- cognitive disability
- visual impairment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SPARK Intervention SPARK 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.
- Primary Outcome Measures
Name Time Method SSPedi (Symptom Screening in Pediatrics) Total Scores Measure will be completed by all participants on day 5±1 day. 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).
- Secondary Outcome Measures
Name Time Method Self-reported individual SSPedi (Symptom Screening in Pediatrics) symptom Measure will be completed by all participants on day 5±1 day Each of the 15 symptoms included in SSPedi will be secondary outcomes. (0 not bothered at all to 4 extremely bothersome)
Faces Pain Scale-Revised Measure will be completed by all participants on day 5±1 day 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.
PedsQL (pediatric Quality of Life) 3.0 Acute Cancer Module Measure will be completed by all participants on day 5±1 day 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.
Trial Locations
- Locations (1)
Lillian Sung
🇨🇦Toronto, Ontario, Canada