Trial Outcomes & Findings for Symptom Screening Linked to Care Pathways (NCT NCT04614662)
NCT ID: NCT04614662
Last Updated: 2025-09-23
Results Overview
SSPedi measures the degree to which 15 symptoms bothered the participant yesterday or today. Each symptom is scored on a 5-point Likert scale ranging from 0 (not at all bothered) to 4 (extremely bothered). The total score ranges from 0 to 60 where higher numbers indicate more bothersome symptoms. The total SSPedi score is reliable, valid and responsive to change in children with cancer 8-18 years of age.(1)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
445 participants
Primary outcome timeframe
Week 8
Results posted on
2025-09-23
Participant Flow
Unit of analysis: Pediatric Healthcare Sites
Participant milestones
| Measure |
Control
At control sites, usual care will be provided, which may or may not include symptom screening, access to CPGs or care pathways. Participants will complete SSPedi to obtain the primary outcome at weeks 0, 4 and 8 but the scores will not be revealed to providers and will not be linked to care pathways.
|
Intervention
Participants enrolled at intervention sites will be prompted to complete symptom screening three times weekly via SPARK with corresponding feedback and links to symptom management care pathways sent to their healthcare providers.
Symptom screening using SPARK can be performed at any time and as often as desired, but screening will be prompted three times weekly for eight weeks.
Each day the participant completes symptom screening and has at least one severely bothersome symptom, the primary healthcare team will receive an email summarizing the symptom report and highlighting symptoms that are "a lot" or "extremely" bothersome.
Upon study activation, we will work with each of the 10 intervention sites to develop site-specific, adapted care pathways that consider relevant work flows, institutional culture and available resources.
SPARK Symptom Screening Linked to Feedback to Providers: Symptom screening three times weekly via SPARK, feedback of symptoms to healthcare providers and development of care pathways for symptom management.
|
|---|---|---|
|
Overall Study
STARTED
|
224 10
|
221 10
|
|
Overall Study
COMPLETED
|
224 10
|
220 10
|
|
Overall Study
NOT COMPLETED
|
0 0
|
1 0
|
Reasons for withdrawal
| Measure |
Control
At control sites, usual care will be provided, which may or may not include symptom screening, access to CPGs or care pathways. Participants will complete SSPedi to obtain the primary outcome at weeks 0, 4 and 8 but the scores will not be revealed to providers and will not be linked to care pathways.
|
Intervention
Participants enrolled at intervention sites will be prompted to complete symptom screening three times weekly via SPARK with corresponding feedback and links to symptom management care pathways sent to their healthcare providers.
Symptom screening using SPARK can be performed at any time and as often as desired, but screening will be prompted three times weekly for eight weeks.
Each day the participant completes symptom screening and has at least one severely bothersome symptom, the primary healthcare team will receive an email summarizing the symptom report and highlighting symptoms that are "a lot" or "extremely" bothersome.
Upon study activation, we will work with each of the 10 intervention sites to develop site-specific, adapted care pathways that consider relevant work flows, institutional culture and available resources.
SPARK Symptom Screening Linked to Feedback to Providers: Symptom screening three times weekly via SPARK, feedback of symptoms to healthcare providers and development of care pathways for symptom management.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Symptom Screening Linked to Care Pathways
Baseline characteristics by cohort
| Measure |
Intervention
n=221 Participants
Participants enrolled at intervention sites will be prompted to complete symptom screening three times weekly via SPARK with corresponding feedback and links to symptom management care pathways sent to their healthcare providers.
Symptom screening using SPARK can be performed at any time and as often as desired, but screening will be prompted three times weekly for eight weeks.
Each day the participant completes symptom screening and has at least one severely bothersome symptom, the primary healthcare team will receive an email summarizing the symptom report and highlighting symptoms that are "a lot" or "extremely" bothersome.
Upon study activation, we will work with each of the 10 intervention sites to develop site-specific, adapted care pathways that consider relevant work flows, institutional culture and available resources.
SPARK Symptom Screening Linked to Feedback to Providers: Symptom screening three times weekly via SPARK, feedback of symptoms to healthcare providers and development of care pathways for symptom management.
|
Control
n=224 Participants
At control sites, usual care will be provided, which may or may not include symptom screening, access to CPGs or care pathways. Participants will complete SSPedi to obtain the primary outcome at weeks 0, 4 and 8 but the scores will not be revealed to providers and will not be linked to care pathways.
|
Total
n=445 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
8-10
|
33 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
70 Participants
n=27 Participants
|
|
Age, Customized
11-14
|
77 Participants
n=93 Participants
|
85 Participants
n=4 Participants
|
162 Participants
n=27 Participants
|
|
Age, Customized
15-18
|
111 Participants
n=93 Participants
|
102 Participants
n=4 Participants
|
213 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=93 Participants
|
95 Participants
n=4 Participants
|
183 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
133 Participants
n=93 Participants
|
129 Participants
n=4 Participants
|
262 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
85 Participants
n=93 Participants
|
63 Participants
n=4 Participants
|
148 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
123 Participants
n=93 Participants
|
139 Participants
n=4 Participants
|
262 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
14 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
113 Participants
n=93 Participants
|
145 Participants
n=4 Participants
|
258 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
22 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
44 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
85 Participants
n=27 Participants
|
|
Baseline total SSPedi Score
|
11.8 sum of the 15 SSPedi items' scores
STANDARD_DEVIATION 8.2 • n=93 Participants
|
13.5 sum of the 15 SSPedi items' scores
STANDARD_DEVIATION 8.2 • n=4 Participants
|
12.7 sum of the 15 SSPedi items' scores
STANDARD_DEVIATION 8.2 • n=27 Participants
|
PRIMARY outcome
Timeframe: Week 8SSPedi measures the degree to which 15 symptoms bothered the participant yesterday or today. Each symptom is scored on a 5-point Likert scale ranging from 0 (not at all bothered) to 4 (extremely bothered). The total score ranges from 0 to 60 where higher numbers indicate more bothersome symptoms. The total SSPedi score is reliable, valid and responsive to change in children with cancer 8-18 years of age.(1)
Outcome measures
| Measure |
Intervention
n=198 Participants
Participants enrolled at intervention sites will be prompted to complete symptom screening three times weekly via SPARK with corresponding feedback and links to symptom management care pathways sent to their healthcare providers.
Symptom screening using SPARK can be performed at any time and as often as desired, but screening will be prompted three times weekly for eight weeks.
Each day the participant completes symptom screening and has at least one severely bothersome symptom, the primary healthcare team will receive an email summarizing the symptom report and highlighting symptoms that are "a lot" or "extremely" bothersome.
Upon study activation, we will work with each of the 10 intervention sites to develop site-specific, adapted care pathways that consider relevant work flows, institutional culture and available resources.
SPARK Symptom Screening Linked to Feedback to Providers: Symptom screening three times weekly via SPARK, feedback of symptoms to healthcare providers and development of care pathways for symptom management.
|
Control
n=213 Participants
At control sites, usual care will be provided, which may or may not include symptom screening, access to CPGs or care pathways. Participants will complete SSPedi to obtain the primary outcome at weeks 0, 4 and 8 but the scores will not be revealed to providers and will not be linked to care pathways.
|
|---|---|---|
|
Symptom Screening in Pediatrics Tool (SSPedi) Total Score
|
7.9 Score on a scale
Standard Deviation 7.2
|
11.4 Score on a scale
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: Week 8Fatigue will be measured using PROMIS. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation of that population. The minimum raw score for this measure is 10 and the maximum raw score is 50. The recall period is the last 7 days and a higher score equals more fatigue. It is reliable and valid in children 8-18 years of age with cancer. This was administered using CAT (Computer Adaptive Test) scoring through REDCap. With a CAT, participant responses guide the system's choice of subsequent items from the full item bank. As additional items are administered, the potential for error is reduced and confidence in the respondent's score increases. T score conversion table 'PROMIS - Fatigue 10a Pediatric' was used.
Outcome measures
| Measure |
Intervention
n=224 Participants
Participants enrolled at intervention sites will be prompted to complete symptom screening three times weekly via SPARK with corresponding feedback and links to symptom management care pathways sent to their healthcare providers.
Symptom screening using SPARK can be performed at any time and as often as desired, but screening will be prompted three times weekly for eight weeks.
Each day the participant completes symptom screening and has at least one severely bothersome symptom, the primary healthcare team will receive an email summarizing the symptom report and highlighting symptoms that are "a lot" or "extremely" bothersome.
Upon study activation, we will work with each of the 10 intervention sites to develop site-specific, adapted care pathways that consider relevant work flows, institutional culture and available resources.
SPARK Symptom Screening Linked to Feedback to Providers: Symptom screening three times weekly via SPARK, feedback of symptoms to healthcare providers and development of care pathways for symptom management.
|
Control
n=221 Participants
At control sites, usual care will be provided, which may or may not include symptom screening, access to CPGs or care pathways. Participants will complete SSPedi to obtain the primary outcome at weeks 0, 4 and 8 but the scores will not be revealed to providers and will not be linked to care pathways.
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Bank v2.0 - Fatigue
|
54.6 T score
Standard Deviation 12.1
|
53.9 T score
Standard Deviation 12.1
|
SECONDARY outcome
Timeframe: Week 8This is a cancer-specific measure of quality of life. 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 minimum value on the scale is 0 and maximum value is 100. PedsQL uses reverse scoring thus a higher score indicates a better outcome. Each question uses a Likert scale ranging from 0 to 4 for raw scores, and 0 to 100 for scaled scores. The breakdown of items per domain is as follows: Pain and Hurt: 2 items, Nausea: 5 items, Procedural Anxiety, Treatment Anxiety, Worry, Perceived Physical Appearance and Communication: 3 items each, Cognitive Problems: 4 items. Scaled items from each subscale are averaged to create a final score, where a higher score indicates a better outcome.
Outcome measures
| Measure |
Intervention
n=224 Participants
Participants enrolled at intervention sites will be prompted to complete symptom screening three times weekly via SPARK with corresponding feedback and links to symptom management care pathways sent to their healthcare providers.
Symptom screening using SPARK can be performed at any time and as often as desired, but screening will be prompted three times weekly for eight weeks.
Each day the participant completes symptom screening and has at least one severely bothersome symptom, the primary healthcare team will receive an email summarizing the symptom report and highlighting symptoms that are "a lot" or "extremely" bothersome.
Upon study activation, we will work with each of the 10 intervention sites to develop site-specific, adapted care pathways that consider relevant work flows, institutional culture and available resources.
SPARK Symptom Screening Linked to Feedback to Providers: Symptom screening three times weekly via SPARK, feedback of symptoms to healthcare providers and development of care pathways for symptom management.
|
Control
n=221 Participants
At control sites, usual care will be provided, which may or may not include symptom screening, access to CPGs or care pathways. Participants will complete SSPedi to obtain the primary outcome at weeks 0, 4 and 8 but the scores will not be revealed to providers and will not be linked to care pathways.
|
|---|---|---|
|
PedsQL 3.0 Acute Cancer Module
PedsQL 3.0 domain score: Pain and hurt
|
68.8 units on a scale
Standard Deviation 24.8
|
69.8 units on a scale
Standard Deviation 26.6
|
|
PedsQL 3.0 Acute Cancer Module
PedsQL 3.0 domain score: Nausea
|
69.2 units on a scale
Standard Deviation 20.7
|
73.9 units on a scale
Standard Deviation 23.4
|
|
PedsQL 3.0 Acute Cancer Module
PedsQL 3.0 domain score: Procedural anxiety
|
62.8 units on a scale
Standard Deviation 29.1
|
66.4 units on a scale
Standard Deviation 30.3
|
|
PedsQL 3.0 Acute Cancer Module
PedsQL 3.0 domain score: Treatment anxiety
|
76.0 units on a scale
Standard Deviation 23.4
|
77.7 units on a scale
Standard Deviation 26.3
|
|
PedsQL 3.0 Acute Cancer Module
PedsQL 3.0 domain score: Worry
|
62.8 units on a scale
Standard Deviation 22.8
|
64.7 units on a scale
Standard Deviation 26.6
|
|
PedsQL 3.0 Acute Cancer Module
PedsQL 3.0 domain score: Cognitive problems
|
69.1 units on a scale
Standard Deviation 20.6
|
70.3 units on a scale
Standard Deviation 21.2
|
|
PedsQL 3.0 Acute Cancer Module
PedsQL 3.0 domain score: Perceived physical appearance
|
73.2 units on a scale
Standard Deviation 26.4
|
74.7 units on a scale
Standard Deviation 25.0
|
|
PedsQL 3.0 Acute Cancer Module
PedsQL 3.0 domain score: Communication
|
73.2 units on a scale
Standard Deviation 21.7
|
77.8 units on a scale
Standard Deviation 21.3
|
SECONDARY outcome
Timeframe: Week 8This outcome will be obtained with a one day window before and after the week 8 patient-reported outcome assessment. The number below represents participants with instances of symptom documentation. Documentation means there was some notation in the medical record of that symptom.
Outcome measures
| Measure |
Intervention
n=224 Participants
Participants enrolled at intervention sites will be prompted to complete symptom screening three times weekly via SPARK with corresponding feedback and links to symptom management care pathways sent to their healthcare providers.
Symptom screening using SPARK can be performed at any time and as often as desired, but screening will be prompted three times weekly for eight weeks.
Each day the participant completes symptom screening and has at least one severely bothersome symptom, the primary healthcare team will receive an email summarizing the symptom report and highlighting symptoms that are "a lot" or "extremely" bothersome.
Upon study activation, we will work with each of the 10 intervention sites to develop site-specific, adapted care pathways that consider relevant work flows, institutional culture and available resources.
SPARK Symptom Screening Linked to Feedback to Providers: Symptom screening three times weekly via SPARK, feedback of symptoms to healthcare providers and development of care pathways for symptom management.
|
Control
n=221 Participants
At control sites, usual care will be provided, which may or may not include symptom screening, access to CPGs or care pathways. Participants will complete SSPedi to obtain the primary outcome at weeks 0, 4 and 8 but the scores will not be revealed to providers and will not be linked to care pathways.
|
|---|---|---|
|
Documentation of Symptoms
Tingly or numb hands or feet
|
15 Participants
|
15 Participants
|
|
Documentation of Symptoms
Feeling dissapointed or sad
|
28 Participants
|
16 Participants
|
|
Documentation of Symptoms
Feeling scared or worried
|
40 Participants
|
26 Participants
|
|
Documentation of Symptoms
Feeling cranky or angry
|
9 Participants
|
7 Participants
|
|
Documentation of Symptoms
Problems with thinking or remembering things
|
2 Participants
|
3 Participants
|
|
Documentation of Symptoms
Changes in how your body or face look
|
8 Participants
|
5 Participants
|
|
Documentation of Symptoms
Feeling tired
|
61 Participants
|
43 Participants
|
|
Documentation of Symptoms
Mouth sores
|
8 Participants
|
8 Participants
|
|
Documentation of Symptoms
Headache
|
19 Participants
|
15 Participants
|
|
Documentation of Symptoms
Hurt or pain
|
46 Participants
|
57 Participants
|
|
Documentation of Symptoms
Throwing up or feeling like you may throwup
|
62 Participants
|
58 Participants
|
|
Documentation of Symptoms
Feeling more or less hungry than you usually do
|
37 Participants
|
22 Participants
|
|
Documentation of Symptoms
Changes in taste
|
2 Participants
|
7 Participants
|
|
Documentation of Symptoms
Constipation
|
15 Participants
|
20 Participants
|
|
Documentation of Symptoms
Diarrhea
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Week 8The number of interventions for each symptom at each reporting period will be recorded and categorized as any intervention provided vs. no intervention provided. Interventions included in the local care pathway will be noted. This outcome will be obtained with a one day window after the week 8 patient-reported outcome assessment. Any intervention regardless of attribution was abstracted from a list of potential, previously-defined interventions for specific symptoms. For example a child life specialist visit was considered an intervention for sadness, anxiety and anger, regardless of visit reason. Interventions for symptoms are recorded regardless of whether a symptom was documented in the chart, for example, acetaminophen was considered an intervention for pain, even if there was no documentation of pain reported. The numbers listed below represent the count of participants with any interventions provided, regardless of documentation for the symptom being recorded.
Outcome measures
| Measure |
Intervention
n=221 Participants
Participants enrolled at intervention sites will be prompted to complete symptom screening three times weekly via SPARK with corresponding feedback and links to symptom management care pathways sent to their healthcare providers.
Symptom screening using SPARK can be performed at any time and as often as desired, but screening will be prompted three times weekly for eight weeks.
Each day the participant completes symptom screening and has at least one severely bothersome symptom, the primary healthcare team will receive an email summarizing the symptom report and highlighting symptoms that are "a lot" or "extremely" bothersome.
Upon study activation, we will work with each of the 10 intervention sites to develop site-specific, adapted care pathways that consider relevant work flows, institutional culture and available resources.
SPARK Symptom Screening Linked to Feedback to Providers: Symptom screening three times weekly via SPARK, feedback of symptoms to healthcare providers and development of care pathways for symptom management.
|
Control
n=224 Participants
At control sites, usual care will be provided, which may or may not include symptom screening, access to CPGs or care pathways. Participants will complete SSPedi to obtain the primary outcome at weeks 0, 4 and 8 but the scores will not be revealed to providers and will not be linked to care pathways.
|
|---|---|---|
|
Provision of Interventions for Symptoms (Independent of Symptom Documentation)
Headache
|
35 Participants
|
42 Participants
|
|
Provision of Interventions for Symptoms (Independent of Symptom Documentation)
Hurt or pain
|
68 Participants
|
70 Participants
|
|
Provision of Interventions for Symptoms (Independent of Symptom Documentation)
Tingly or numb hands or feet
|
17 Participants
|
25 Participants
|
|
Provision of Interventions for Symptoms (Independent of Symptom Documentation)
Throwing up or feeling like you may throw up
|
119 Participants
|
134 Participants
|
|
Provision of Interventions for Symptoms (Independent of Symptom Documentation)
Feeling more or less hungry than you usually do
|
18 Participants
|
20 Participants
|
|
Provision of Interventions for Symptoms (Independent of Symptom Documentation)
Changes in taste
|
2 Participants
|
0 Participants
|
|
Provision of Interventions for Symptoms (Independent of Symptom Documentation)
Constipation
|
59 Participants
|
57 Participants
|
|
Provision of Interventions for Symptoms (Independent of Symptom Documentation)
Diarrhea
|
0 Participants
|
1 Participants
|
|
Provision of Interventions for Symptoms (Independent of Symptom Documentation)
Feeling dissapointed or sad
|
52 Participants
|
82 Participants
|
|
Provision of Interventions for Symptoms (Independent of Symptom Documentation)
Feeling scared or worried
|
54 Participants
|
96 Participants
|
|
Provision of Interventions for Symptoms (Independent of Symptom Documentation)
Feeling cranky or angry
|
48 Participants
|
67 Participants
|
|
Provision of Interventions for Symptoms (Independent of Symptom Documentation)
Problems with thinking or remembering things
|
5 Participants
|
5 Participants
|
|
Provision of Interventions for Symptoms (Independent of Symptom Documentation)
Changes in how your body or face look
|
0 Participants
|
1 Participants
|
|
Provision of Interventions for Symptoms (Independent of Symptom Documentation)
Feeling tired
|
12 Participants
|
15 Participants
|
|
Provision of Interventions for Symptoms (Independent of Symptom Documentation)
Mouth sores
|
28 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 8 weeksNumber of visits to the emergency room and unplanned clinic visits and hospitalizations will be summed over the 8 week on-study period.
Outcome measures
| Measure |
Intervention
n=221 Participants
Participants enrolled at intervention sites will be prompted to complete symptom screening three times weekly via SPARK with corresponding feedback and links to symptom management care pathways sent to their healthcare providers.
Symptom screening using SPARK can be performed at any time and as often as desired, but screening will be prompted three times weekly for eight weeks.
Each day the participant completes symptom screening and has at least one severely bothersome symptom, the primary healthcare team will receive an email summarizing the symptom report and highlighting symptoms that are "a lot" or "extremely" bothersome.
Upon study activation, we will work with each of the 10 intervention sites to develop site-specific, adapted care pathways that consider relevant work flows, institutional culture and available resources.
SPARK Symptom Screening Linked to Feedback to Providers: Symptom screening three times weekly via SPARK, feedback of symptoms to healthcare providers and development of care pathways for symptom management.
|
Control
n=224 Participants
At control sites, usual care will be provided, which may or may not include symptom screening, access to CPGs or care pathways. Participants will complete SSPedi to obtain the primary outcome at weeks 0, 4 and 8 but the scores will not be revealed to providers and will not be linked to care pathways.
|
|---|---|---|
|
Number of Emergency Department Visits and Unplanned Clinic Visits and Hospitalizations
|
1.82 Unplanned Health Care Encounters
Standard Deviation 2.34
|
1.12 Unplanned Health Care Encounters
Standard Deviation 1.62
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place