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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPARK Intervention | Experimental | 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. |
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| Standard of Care Arm | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPARK | Other | see above |
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| 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 at baseline (day 1) and day 5±1 day. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | The subscale SSPedi score is a validated measure that reflects the burden of a bothersome symptom experienced. Each of the 15 symptoms assessed by the SSPedi questionnaire will serve as secondary outcomes. The subscale uses a Likert score that ranges from 0 (not at all bothered) to 4 (extremely bothered). The reported values represent the number of participants who had symptoms rated as severely bothersome, defined as a score of 3 or 4 on the subscale. Higher reported scores indicate a higher number of participants that reported the level of bother for that symptom as a 3 or a 4. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lillian Sung, MD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lillian Sung | Toronto | Ontario | M5G 1X8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39535812 | Derived | Dupuis LL, Johnston DL, Dix D, McKillop S, Cook S, Crellin-Parsons N, Kulkarni K, Patel S, Vanan ML, Gibson P, Soman D, Kuczynski S, Tomlinson GA, Sung L. Symptom Screening for Hospitalized Pediatric Patients With Cancer: A Randomized Clinical Trial. JAMA Pediatr. 2025 Jan 1;179(1):11-18. doi: 10.1001/jamapediatrics.2024.4727. |
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No participants were enrolled but excluded from assignment to study groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | SPARK Intervention | 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. SPARK: see above |
| FG001 | Standard of Care Arm | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | SPARK Intervention | 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. SPARK: see above |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | score on a scale | Measure will be completed by all participants at baseline (day 1) and day 5±1 day. |
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Adverse event data collected while participants were on study (period of 5 days ± 1 day)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SPARK Intervention | 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. SPARK: see above |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lillian Sung | The Hospital for Sick Children | 416 813 5287 | lillian.sung@sickkids.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 3, 2023 | May 12, 2025 | Prot_SAP_001.pdf |
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| Measure will be completed by all participants on baseline (day 1) and 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 1 (baseline) and 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. They produce 8 domain scores ranging from 0 to 100, with higher scores denote better health. | Measure will be completed by all participants on day 1 (baseline) and day 5±1 day |
| BG001 | Standard of Care Arm | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Standard of Care Arm | 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. |
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| Secondary | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | The subscale SSPedi score is a validated measure that reflects the burden of a bothersome symptom experienced. Each of the 15 symptoms assessed by the SSPedi questionnaire will serve as secondary outcomes. The subscale uses a Likert score that ranges from 0 (not at all bothered) to 4 (extremely bothered). The reported values represent the number of participants who had symptoms rated as severely bothersome, defined as a score of 3 or 4 on the subscale. Higher reported scores indicate a higher number of participants that reported the level of bother for that symptom as a 3 or a 4. | Posted | Count of Participants | Participants | Measure will be completed by all participants on baseline (day 1) and day 5±1 day. |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Measure will be completed by all participants on day 1 (baseline) and day 5±1 day |
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| Secondary | 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. They produce 8 domain scores ranging from 0 to 100, with higher scores denote better health. | Posted | Mean | Standard Deviation | score on a scale | Measure will be completed by all participants on day 1 (baseline) and day 5±1 day |
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| 0 |
| 176 |
| 0 |
| 176 |
| 0 |
| 176 |
| EG001 | Standard of Care Arm | 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. | 0 | 169 | 0 | 169 | 0 | 169 |
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| SSPedi: Feeling cranky or angry baseline |
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| SSPedi: Problems thinking or remembering things baseline |
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| SSPedi: Changes in how your body or face look baseline |
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| SSPedi: Feeling tired baseline |
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| SSPedi: Mouth sores baseline |
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| SSPedi: Headache baseline |
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| SSPedi: Hurt or pain (other than headache) baseline |
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| SSPedi: Tingly or numb hands or feet baseline |
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| SSPedi: Throwing up or feeling like you may throw up baseline |
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| SSPedi: Feeling more or less hungry than you usually do baseline |
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| SSPedi: Changes in taste baseline |
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| SSPedi: Constipation baseline |
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| SSPedi: Diarrhea baseline |
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| SSPedi: Feeling dissapointed or sad day 5 |
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| SSPedi: Feeling scared or worried day 5 |
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| SSPedi: Feeling cranky or angry day 5 |
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| SSPedi: Problems with thinking or remembering things day 5 |
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| SSPedi: Changes in how your body or face look day 5 |
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| SSPedi: Feeling tired day 5 |
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| SSPedi: Mouth sores day 5 |
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| SSPedi: Headache day 5 |
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| SSPedi: Hurt or pain day 5 |
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| SSPedi: Tingly or numb hands or feet day 5 |
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| SSPedi: Throwing up or feeling like you may throw up day 5 |
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| SSPedi: Feeling more or less hungry than you usually do day 5 |
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| SSPedi: Changes in taste day 5 |
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| SSPedi: Constipation day 5 |
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| SSPedi: Diarrhea day 5 |
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| PedsQL 3.0 Procedural Anxiety baseline |
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| PedsQL 3.0 Treatment Anxiety baseline |
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| PedsQL 3.0 Worry baseline |
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| PedsQL 3.0 Cognitive problems baseline |
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| PedsQL 3.0 Perceived physical appearance baseline |
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| PedsQL 3.0 Communication baseline |
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| PedsQL 3.0 Pain and hurt day 5 |
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| PedsQL 3.0 Nausea day 5 |
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| PedsQL 3.0 Procedural anxiety day 5 |
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| PedsQL 3.0 Treatment anxiety day 5 |
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| PedsQL 3.0 Worry day 5 |
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| PedsQL 3.0 Cognitive problems day 5 |
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| PedsQL 3.0 Percieved physical appearance day 5 |
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| PedsQL 3.0 Communication day 5 |
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