Trial Outcomes & Findings for SPARK Symptom Screening and Feedback to Providers (NCT NCT03593525)

Last Updated: 2025-08-08

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

345 participants

Primary outcome timeframe

Measure will be completed by all participants at baseline (day 1) and day 5±1 day.

Results posted on

2025-08-08

Participant Flow

No participants were enrolled but excluded from assignment to study groups.

Participant milestones

Participant milestones
Measure	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	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.
Overall Study STARTED	176	169
Overall Study COMPLETED	168	164
Overall Study NOT COMPLETED	8	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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.
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	7	5

Baseline Characteristics

SPARK Symptom Screening and Feedback to Providers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SPARK Intervention n=176 Participants 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	Standard of Care Arm n=169 Participants 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.	Total n=345 Participants Total of all reporting groups
Age, Categorical <=18 years	176 Participants n=5 Participants	169 Participants n=7 Participants	345 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	13.9 years n=5 Participants	13.6 years n=7 Participants	13.8 years n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	74 Participants n=7 Participants	150 Participants n=5 Participants
Sex: Female, Male Male	100 Participants n=5 Participants	95 Participants n=7 Participants	195 Participants n=5 Participants
Race/Ethnicity, Customized Aboriginal	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Arab or West Asian	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Race/Ethnicity, Customized Asian	53 Participants n=5 Participants	27 Participants n=7 Participants	80 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Latin American	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized White	78 Participants n=5 Participants	92 Participants n=7 Participants	170 Participants n=5 Participants
Race/Ethnicity, Customized Other race or mixed race	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or missing	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Prefer not to say	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment Canada	176 participants n=5 Participants	169 participants n=7 Participants	345 participants n=5 Participants

PRIMARY outcome

Timeframe: Measure will be completed by all participants at baseline (day 1) and day 5±1 day.

Outcome measures

Outcome measures
Measure	SPARK Intervention n=168 Participants 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	Standard of Care Arm n=164 Participants 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.
SSPedi (Symptom Screening in Pediatrics) Total Scores SSPedi Baseline Total Scores	13.2 score on a scale Standard Deviation 8.0	13.1 score on a scale Standard Deviation 8.2
SSPedi (Symptom Screening in Pediatrics) Total Scores SSPedi Day 5 Total Scores	10.2 score on a scale Standard Deviation 7.4	12.7 score on a scale Standard Deviation 8.3

SECONDARY outcome

Timeframe: Measure will be completed by all participants on baseline (day 1) and day 5±1 day.

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.

Outcome measures

Outcome measures
Measure	SPARK Intervention n=168 Participants 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	Standard of Care Arm n=164 Participants 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.
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Feeling cranky or angry day 5	8 Participants	16 Participants
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Problems with thinking or remembering things day 5	2 Participants	9 Participants
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Feeling sad or dissapointed baseline	18 Participants	11 Participants
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Feeling scared or worried baseline	18 Participants	17 Participants
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Feeling cranky or angry baseline	10 Participants	11 Participants
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Problems thinking or remembering things baseline	11 Participants	8 Participants
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Changes in how your body or face look baseline	16 Participants	15 Participants
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Feeling tired baseline	55 Participants	54 Participants
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Mouth sores baseline	12 Participants	9 Participants
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Headache baseline	10 Participants	11 Participants
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Hurt or pain (other than headache) baseline	24 Participants	24 Participants
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Tingly or numb hands or feet baseline	10 Participants	5 Participants
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Throwing up or feeling like you may throw up baseline	17 Participants	19 Participants
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Feeling more or less hungry than you usually do baseline	40 Participants	30 Participants
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Changes in taste baseline	24 Participants	19 Participants
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Constipation baseline	16 Participants	10 Participants
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Diarrhea baseline	15 Participants	11 Participants
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Feeling dissapointed or sad day 5	8 Participants	10 Participants
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Feeling scared or worried day 5	4 Participants	6 Participants
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Changes in how your body or face look day 5	9 Participants	18 Participants
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Feeling tired day 5	31 Participants	53 Participants
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Mouth sores day 5	9 Participants	12 Participants
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Headache day 5	8 Participants	8 Participants
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Hurt or pain day 5	15 Participants	22 Participants
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Tingly or numb hands or feet day 5	4 Participants	4 Participants
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Throwing up or feeling like you may throw up day 5	17 Participants	23 Participants
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Feeling more or less hungry than you usually do day 5	21 Participants	35 Participants
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Changes in taste day 5	14 Participants	18 Participants
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Constipation day 5	6 Participants	14 Participants
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom SSPedi: Diarrhea day 5	8 Participants	11 Participants

SECONDARY outcome

Timeframe: Measure will be completed by all participants on day 1 (baseline) and 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.

Outcome measures

Outcome measures
Measure	SPARK Intervention n=168 Participants 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	Standard of Care Arm n=164 Participants 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.
Faces Pain Scale-Revised Face Pain Scale-Revised score baseline	1.6 score on a scale Standard Deviation 1.9	1.4 score on a scale Standard Deviation 1.9
Faces Pain Scale-Revised Face Pain Scale-Revised score day 5	1.7 score on a scale Standard Deviation 2.1	1.4 score on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: Measure will be completed by all participants on day 1 (baseline) and 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. They produce 8 domain scores ranging from 0 to 100, with higher scores denote better health.

Outcome measures

Outcome measures
Measure	SPARK Intervention n=168 Participants 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	Standard of Care Arm n=164 Participants 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.
PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module PedsQL 3.0 Treatment Anxiety baseline	77.0 score on a scale Standard Deviation 25.7	78.6 score on a scale Standard Deviation 25.8
PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module PedsQL 3.0 Worry baseline	62.4 score on a scale Standard Deviation 26.9	62.9 score on a scale Standard Deviation 27.0
PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module PedsQL 3.0 Cognitive problems baseline	69.7 score on a scale Standard Deviation 21.3	70.1 score on a scale Standard Deviation 21.3
PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module PedsQL 3.0 Perceived physical appearance baseline	75.3 score on a scale Standard Deviation 24.4	75.4 score on a scale Standard Deviation 26.2
PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module PedsQL 3.0 Communication baseline	72.9 score on a scale Standard Deviation 22.7	75.1 score on a scale Standard Deviation 23.1
PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module PedsQL 3.0 Pain and hurt day 5	73.1 score on a scale Standard Deviation 22.6	72.8 score on a scale Standard Deviation 26.1
PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module PedsQL 3.0 Nausea day 5	69.2 score on a scale Standard Deviation 21.8	69.5 score on a scale Standard Deviation 31.8
PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module PedsQL 3.0 Procedural anxiety day 5	69.5 score on a scale Standard Deviation 29.9	66.5 score on a scale Standard Deviation 31.8
PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module PedsQL 3.0 Treatment anxiety day 5	80.5 score on a scale Standard Deviation 23.7	81.9 score on a scale Standard Deviation 23.5
PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module PedsQL 3.0 Worry day 5	68.7 score on a scale Standard Deviation 26.2	69.1 score on a scale Standard Deviation 25.4
PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module PedsQL 3.0 Cognitive problems day 5	74.2 score on a scale Standard Deviation 21.4	74.4 score on a scale Standard Deviation 21.3
PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module PedsQL 3.0 Percieved physical appearance day 5	79.2 score on a scale Standard Deviation 22.6	78.2 score on a scale Standard Deviation 25.5
PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module PedsQL 3.0 Communication day 5	76.4 score on a scale Standard Deviation 22.3	78.1 score on a scale Standard Deviation 21.2
PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module PedsQL 3.0 Pain and hurt baseline	66.5 score on a scale Standard Deviation 26.5	68.3 score on a scale Standard Deviation 26.5
PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module PedsQL 3.0 Nausea baseline	69.2 score on a scale Standard Deviation 22.2	71.6 score on a scale Standard Deviation 20.7
PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module PedsQL 3.0 Procedural Anxiety baseline	65.5 score on a scale Standard Deviation 29.4	63.8 score on a scale Standard Deviation 32.7

Adverse Events

SPARK Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lillian Sung

The Hospital for Sick Children

Phone: 416 813 5287

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place