An interventional study of SPARK Symptom Screening Linked to Feedback to Providers in Pediatric Cancer and Quality of Life, sponsored by The Hospital for Sick Children. Completed at 21 sites in 2 countries. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-09-23.
Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Supportive care
Most children with cancer survive because they are given intensive treatments, but unfortunately, these treatments are associated with distressing symptoms. To address this problem, we developed the Symptom Screening in Pediatrics Tool (SSPedi) so that children receiving cancer treatments can communicate their bothersome symptoms, and Supportive care Prioritization, Assessment and Recommendations for Kids (SPARK), a web-based application that links identified symptoms to supportive care guidelines for symptom management. To establish that these tools improve the lives of children newly diagnosed with cancer, we will conduct a trial that randomizes 20 pediatric cancer institutions and measures the impact of three times weekly symptom screening, symptom feedback to healthcare providers and the development of care pathways for symptom management to improve total symptom burden, fatigue and quality of life.
Aims 1 and 2: Among children with newly diagnosed cancer, to determine if symptom screening and feedback to healthcare providers at least three times weekly and locally-adapted symptom management care pathways, when compared to usual care:
Aim 1. Improves overall self-reported symptom scores (total SSPedi score), fatigue (PROMIS-Fatigue) and cancer-specific QoL (PedsQL 3.0 Acute Cancer Module) over 8 weeks Hypothesis: Symptom screening and care pathways will improve symptoms, fatigue and QoL
Aim 2. Improves symptom documentation, increases provision of interventions for symptoms, and reduces emergency department visits and unplanned clinic visits and hospitalizations over 8 weeks Hypotheses: Symptom screening and care pathways will increase symptom documentation and provision of interventions for symptoms, and will reduce healthcare utilization.
Aim 3: As an exploratory aim, we will evaluate key elements of the intervention related to the external validity and generalizability of the intervention effects using the RE-AIM framework.
Overall Strategy This is a cluster randomized trial including 20 pediatric oncology sites. The coordinating center is The Hospital for Sick Children in Toronto, Canada. Sites will be randomized to either systematic symptom screening via SPARK with provision of symptom reports to healthcare providers containing links to care pathways for symptom management (intervention) or usual care (control).
Research Methods Eligibility: We will include children with cancer who: (1) are 8-18 years of age at enrollment (SSPedi is validated in this age range); (2) are English or Spanish-speaking (all PROs are validated in these languages in this age range); (3) have any newly diagnosed cancer; (4) have a plan for any chemotherapy, radiotherapy or surgery; and (5) enroll within 28 days after treatment initiation. Exclusion criteria will be cognitive disability (attending lower than second grade or equivalent) or visual impairment (cannot see SPARK even with corrective lens).
Procedures: In this cluster randomized trial, we will randomize sites to either intervention or control groups. At both intervention and control sites, we will enroll participants within 28 days after treatment initiation. Eligible participants will be identified by site personnel and the study will be explained to them by trained research team members. Participant capacity to consent will be assessed by the clinical or research team according to institutional standards. After the study has been explained and sufficient time has been provided to ensure all questions have been answered, informed consent and assent will be obtained from participants and guardians as appropriate. For those who decline to contribute PROs, they will be given the option to only participate in a retrospective chart review to evaluate symptom documentation, intervention provision and healthcare utilization. Careful tracking of all newly diagnosed patients by site research personnel will occur to determine how many patients are approached and consented, and where possible, reasons for declining participation.
For all enrolled participants who will be contributing PROs (excluding those only involved in the retrospective chart review), a personal SPARK account will be created to allow SSPedi to be completed and symptom results to be recorded. At the 10 intervention sites, site-specific symptom management care pathways will be adapted from template care pathways for each of the 15 symptoms included in SSPedi. Enrolled participants will be prompted by text or email to complete symptom screening three times weekly via SPARK with corresponding feedback sent to their healthcare providers. Symptom reports will contain links to care pathways for symptom management. Active intervention will last for eight weeks starting from the date of enrollment. At the 10 control sites, 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. Usual care will be provided to participants at control sites and thus, there will be no study-requested routine, systematic symptom screening, symptom feedback to providers, or linkage to care pathways. If sites already routinely perform systematic symptom screening or use care pathways for symptom management, these may be continued but their use will be recorded.
At both intervention and control sites, demographic information including age, sex, race, ethnicity, diagnosis, cancer stage, family socioeconomic information and treatment plan will be collected at enrollment. The following PROs will be obtained by trained research staff at baseline, week 4 and week 8 for all participants: SSPedi, PROMIS Fatigue and the PedsQL 3.0 Acute Cancer Module (Aim 1). We will contact participants ahead of time to coordinate the week 4 and 8 PROs so that they can be completed in person during hospitalizations or clinic visits. If unable to arrange completion of these PROs in person, we will use their contact information to complete the questionnaires by email, text or over the phone. Data from health records (Aim 2) will be abstracted for all enrolled participants. Relapse and cancer treatment received information will be collected at the end of the study.
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Exclusion Criteria:
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.
Behavioral: SPARK Symptom Screening Linked to Feedback to Providers
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 three times weekly via SPARK, feedback of symptoms to healthcare providers and development of care pathways for symptom management.
Symptom Screening in Pediatrics Tool (SSPedi) Total Score
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)
Time frame: Week 8
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Bank v2.0 - Fatigue
Fatigue 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.
Time frame: Week 8
PedsQL 3.0 Acute Cancer Module
This 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.
Time frame: Week 8
Documentation of Symptoms
This 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.
Time frame: Week 8
Provision of Interventions for Symptoms (Independent of Symptom Documentation)
The 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.
Time frame: Week 8
Number of Emergency Department Visits and Unplanned Clinic Visits and Hospitalizations
Number of visits to the emergency room and unplanned clinic visits and hospitalizations will be summed over the 8 week on-study period.
Time frame: 8 weeks
| Milestone | Control | Intervention |
|---|---|---|
| Started | 224 | 221 |
| Completed | 224 | 220 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
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)
| Score on a scale | Intervention | Control |
|---|---|---|
| Symptom Screening in Pediatrics Tool (SSPedi) Total Score | 7.9 ± 7.2 | 11.4 ± 8.7 |
Fatigue 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.
| T score | Control | Intervention |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Bank v2.0 - Fatigue | 54.6 ± 12.1 | 53.9 ± 12.1 |
This 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.
| units on a scale | Control | Intervention |
|---|---|---|
| PedsQL 3.0 domain score: Pain and hurt | 68.8 ± 24.8 | 69.8 ± 26.6 |
| PedsQL 3.0 domain score: Nausea | 69.2 ± 20.7 | 73.9 ± 23.4 |
| PedsQL 3.0 domain score: Procedural anxiety | 62.8 ± 29.1 | 66.4 ± 30.3 |
| PedsQL 3.0 domain score: Treatment anxiety | 76.0 ± 23.4 | 77.7 ± 26.3 |
| PedsQL 3.0 domain score: Worry | 62.8 ± 22.8 | 64.7 ± 26.6 |
| PedsQL 3.0 domain score: Cognitive problems | 69.1 ± 20.6 | 70.3 ± 21.2 |
| PedsQL 3.0 domain score: Perceived physical appearance | 73.2 ± 26.4 | 74.7 ± 25.0 |
| PedsQL 3.0 domain score: Communication | 73.2 ± 21.7 | 77.8 ± 21.3 |
This 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.
| Participants | Control | Intervention |
|---|---|---|
| Feeling dissapointed or sad | 28 | 16 |
| Feeling scared or worried | 40 | 26 |
| Feeling cranky or angry | 9 | 7 |
| Problems with thinking or remembering things | 2 | 3 |
| Changes in how your body or face look | 8 | 5 |
| Feeling tired | 61 | 43 |
| Mouth sores | 8 | 8 |
| Headache | 19 | 15 |
| Hurt or pain | 46 | 57 |
| Tingly or numb hands or feet | 15 | 15 |
| Throwing up or feeling like you may throwup | 62 | 58 |
| Feeling more or less hungry than you usually do | 37 | 22 |
| Changes in taste | 2 | 7 |
| Constipation | 15 | 20 |
| Diarrhea | 3 | 6 |
The 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.
| Participants | Intervention | Control |
|---|---|---|
| Feeling dissapointed or sad | 52 | 82 |
| Feeling scared or worried | 54 | 96 |
| Feeling cranky or angry | 48 | 67 |
| Problems with thinking or remembering things | 5 | 5 |
| Changes in how your body or face look | 0 | 1 |
| Feeling tired | 12 | 15 |
| Mouth sores | 28 | 23 |
| Headache | 35 | 42 |
| Hurt or pain | 68 | 70 |
| Tingly or numb hands or feet | 17 | 25 |
| Throwing up or feeling like you may throw up | 119 | 134 |
| Feeling more or less hungry than you usually do | 18 | 20 |
| Changes in taste | 2 | 0 |
| Constipation | 59 | 57 |
| Diarrhea | 0 | 1 |
Number of visits to the emergency room and unplanned clinic visits and hospitalizations will be summed over the 8 week on-study period.
| Unplanned Health Care Encounters | Intervention | Control |
|---|---|---|
| Number of Emergency Department Visits and Unplanned Clinic Visits and Hospitalizations | 1.82 ± 2.34 | 1.12 ± 1.62 |
Collected over 8 weeks; Adverse events were monitored for the duration of the study with enrolled participants (August 2, 2021 - October 18, 2023). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/221 (0%) | 0/221 (0%) | 0/221 (0%) |
| Control | 0/224 (0%) | 0/224 (0%) | 0/224 (0%) |
| Age, Customized(Participants) | Intervention | Control | Total |
|---|---|---|---|
| 8-10 | 33 | 37 | 70 |
| 11-14 | 77 | 85 | 162 |
| 15-18 | 111 | 102 | 213 |
| Sex: Female, Male(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Female | 88 | 95 | 183 |
| Male | 133 | 129 | 262 |
| Ethnicity (NIH/OMB)(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 85 | 63 | 148 |
| Not Hispanic or Latino | 123 | 139 | 262 |
| Unknown or Not Reported | 13 | 22 | 35 |
| Race (NIH/OMB)(Participants) | Intervention | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 4 | 6 |
| Asian | 13 | 7 | 20 |
| Native Hawaiian or Other Pacific Islander | 14 | 1 | 15 |
| Black or African American | 13 | 14 | 27 |
| White | 113 | 145 | 258 |
| More than one race | 22 | 12 | 34 |
| Unknown or Not Reported | 44 | 41 | 85 |
| Baseline total SSPedi Score(sum of the 15 SSPedi items' scores) | Intervention | Control | Total |
|---|---|---|---|
| Mean | 11.8 ± 8.2 | 13.5 ± 8.2 | 12.7 ± 8.2 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The full data set including the patient-reported outcome data will be available publically following trial completion after ensuring that no patient can be identified and no disclosure of personal health information. The data will become available no later than one year after the primary publication and will be available for at least five years.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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