Pediatric CancerNCT04614662
Symptom Screening Linked to Care Pathways
A study testing SPARK Symptom Screening Linked to Feedback to Providers in people with Pediatric Cancer and Quality of Life, run by The Hospital for Sick Children at 21 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Pediatric Cancer, Quality of Life
- What is being tested?
- SPARK Symptom Screening Linked to Feedback to Providers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 445 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 2 Aug 2021to 25 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 8-18 years of age at enrollment
- English or Spanish-speaking
- Any newly diagnosed cancer
- Have a plan for any chemotherapy, radiotherapy or surgery
- Enroll within 28 days after treatment initiation
Who cannot join
- Cognitive disability (attending minimum second grade or equivalent)
- Visual impairment (cannot see SPARK even with corrective lens)
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States20 sites
University of Colorado Denver
Aurora, Colorado, 80045-2571
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
Unity Point Health - Blank Children's Hospital
Des Moines, Iowa, 50309
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Kapi'olani Medical Center for Women & Children
Honolulu, Hawaii, 96826
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
The University of Iowa
Iowa City, Iowa, 52242
Nemours Children's Health, Jacksonville
Jacksonville, Florida, 32207
Children's Hospital Los Angeles
Los Angeles, California, 90027-6062
Vanderbilt University Medical Center
Nashville, Tennessee, 37203-1161
Children's Hospital
New Orleans, Louisiana, 70118
The Trustees of Columbia University in the City of New York
New York, New York, 10032
Nemours Children's Hospital, Florida
Orlando, Florida, 32827
Phoenix Children's Hospital
Phoenix, Arizona, 85016-7710
The Leland Stanford Junior University
Redwood City, California, 94305-2004
Virginia Commonwealth University
Richmond, Virginia, 23298-0568
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3901
Washington University School of Medicine
St Louis, Missouri, 63110
Nemours Children's Hospital, Delaware
Wilmington, Delaware, 19803
About this study
Official title: Symptom Screening Linked to Care Pathways for Children With Cancer: a Cluster Randomized Trial
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.
Read the detailed description
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.
- Conditions
- Pediatric Cancer, Quality of Life
- Being tested
- SPARK Symptom Screening Linked to Feedback to Providers
- Keywords
- Pediatric Oncology, Cluster Randomized Clinical Trial, Symptom Screening, Quality of Life
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPARK Symptom Screening Linked to Feedback to ProvidersBehavioural
Symptom screening three times weekly via SPARK, feedback of symptoms to healthcare providers and development of care pathways for symptom management.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: SPARK Symptom Screening Linked to Feedback to Providers |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Week 8
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start2 Aug 2021
- Primary completion18 Oct 2023
- Study completion25 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster Randomized Trial
- Masking
- None (open label)
- Enrolment
- 445 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Lillian Sung, The Hospital for Sick Children
- Investigators
- Lillian Sung, MD, PhD, Principal investigator, The Hospital for Sick ChildrenLaura Lee Dupuis, RPh, PhD, Principal investigator, The Hospital for Sick ChildrenAllison Grimes, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614662
- Sponsor's protocol ID
- 1000068699
- Other IDs
- 1R01CA251112-01, PJT-169165
- Status last verified
- Sep 2025
- First submitted
- 21 Oct 2020
- Last updated
- 23 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Dupuis LL, Johnston DL, Baggott C, Hyslop S, Tomlinson D, Gibson P, Orsey A, Dix D, Price V, Vanan M, Portwine C, Kuczynski S, Spiegler B, Tomlinson GA, Sung L. Validation of the Symptom Screening in Pediatrics Tool in Children Receiving Cancer Treatments. J Natl Cancer Inst. 2018 Jun 1;110(6):661-668. doi: 10.1093/jnci/djx250.
PubMed 29272441Hinds PS, Nuss SL, Ruccione KS, Withycombe JS, Jacobs S, DeLuca H, Faulkner C, Liu Y, Cheng YI, Gross HE, Wang J, DeWalt DA. PROMIS pediatric measures in pediatric oncology: valid and clinically feasible indicators of patient-reported outcomes. Pediatr Blood Cancer. 2013 Mar;60(3):402-8. doi: 10.1002/pbc.24233. Epub 2012 Jul 24.
PubMed 22829446Varni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P. The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer. 2002 Apr 1;94(7):2090-106. doi: 10.1002/cncr.10428.
PubMed 11932914Yan AP, Dupuis LL, Aftandilian C, Agarwal V, Baggott C, Beauchemin MP, Bradfield SM, Cannone D, Caywood EH, Crellin-Parsons N, Demedis J, Dickens D, Esbenshade AJ, Freyer DR, Grimes AC, Kelly KM, King AA, Klesges LM, Kyono W, Nagasubramanian R, Orgel E, Orsey AD, Roth ME, Sherani F, Vettese E, Walsh A, Woods-Swafford W, Yu LC, Tomlinson GA, Sung L. Factors Associated With Symptom Burden Among Pediatric Patients With Cancer. JCO Oncol Pract. 2026 Jun;22(6):1087-1095. doi: 10.1200/OP-25-00244. Epub 2025 Aug 14.
PubMed 40811761Dupuis LL, Vettese E, Aftandilian C, Agarwal V, Baggott C, Bradfield SM, Crellin-Parsons N, Freyer DR, Kelly KM, King AA, Kyono W, Nagasubramanian R, Orgel E, Roth ME, Sherani F, Yu L, Grimes AC, Beauchemin MP, Klesges LM, Tomlinson GA, Sung L. Factors Associated With Self-Report Symptom Screening Adherence in Pediatric Cancer Patients. Cancer Med. 2025 Jul;14(14):e71053. doi: 10.1002/cam4.71053.
PubMed 40686265Dupuis LL, Vettese E, Grimes AC, Beauchemin MP, Klesges LM, Baggott C, Demedis J, Aftandilian C, Freyer DR, Crellin-Parsons N, Orgel E, Dickens D, Kelly KM, Kyono W, Walsh A, Sherani F, Cannone D, Orsey AD, King AA, Yu L, Woods-Swafford W, Bradfield SM, Roth ME, Esbenshade AJ, Caywood EH, Agarwal V, Nagasubramanian R, Tomlinson GA, Sung L. Symptom Screening Linked to Care Pathways for Pediatric Patients With Cancer: A Randomized Clinical Trial. JAMA. 2024 Dec 17;332(23):1981-1991. doi: 10.1001/jama.2024.19585.
PubMed 39535768Vettese E, Sherani F, King AA, Yu L, Aftandilian C, Baggott C, Agarwal V, Nagasubramanian R, Kelly KM, Freyer DR, Orgel E, Bradfield SM, Kyono W, Roth M, Klesges LM, Beauchemin M, Grimes A, Tomlinson G, Dupuis LL, Sung L. Symptom management care pathway adaptation process and specific adaptation decisions. BMC Cancer. 2023 Apr 17;23(1):350. doi: 10.1186/s12885-023-10835-0.
PubMed 37069510Dupuis LL, Grimes A, Vettese E, Klesges LM, Sung L. Readiness to Implement Symptom Management Care Pathways in Pediatric Cancer. Res Sq [Preprint]. 2020 Dec 30:rs.3.rs-136225. doi: 10.21203/rs.3.rs-136225/v1.
PubMed 33398260
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Screening Linked to Care Pathways for Children With Cancer: a Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT04614662
- Acronym / sponsor ID
- 1000068699
- Conditions
- Pediatric Cancer, Quality of Life
- Keywords
- Pediatric Oncology, Cluster Randomized Clinical Trial, Symptom Screening, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 445 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 18 Oct 2023 (actual)
- Study completion
- 25 Oct 2023 (actual)
- First posted
- 4 Nov 2020 (actual)
- Results
- Posted 23 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: SPARK Symptom Screening Linked to Feedback to ProvidersParticipants 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 8-18 years of age at enrollment
- English or Spanish-speaking
- Any newly diagnosed cancer
- Have a plan for any chemotherapy, radiotherapy or surgery
- Enroll within 28 days after treatment initiation
Key exclusion criteria (2 listed)
- Cognitive disability (attending minimum second grade or equivalent)
- Visual impairment (cannot see SPARK even with corrective lens)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPARK Symptom Screening Linked to Feedback to ProvidersSymptom screening three times weekly via SPARK, feedback of symptoms to healthcare providers and development of care pathways for symptom management. | Behavioural | Intervention |
Primary outcome
Symptom Screening in Pediatrics Tool (SSPedi) Total Score
Time frame: Week 8
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)
5 secondary outcomes
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Bank v2.0 - Fatigue
Time frame: Week 8
PedsQL 3.0 Acute Cancer Module
Time frame: Week 8
Documentation of Symptoms
Time frame: Week 8
Provision of Interventions for Symptoms (Independent of Symptom Documentation)
Time frame: Week 8
Number of Emergency Department Visits and Unplanned Clinic Visits and Hospitalizations
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29272441Dupuis LL, Johnston DL, Baggott C, Hyslop S, Tomlinson D, Gibson P, Orsey A, Dix D, Price V, Vanan M, Portwine C, Kuczynski S, Spiegler B, Tomlinson GA, Sung L. Validation of the Symptom Screening in Pediatrics Tool in Children Receiving Cancer Treatments. J Natl Cancer Inst. 2018 Jun 1;110(6):661-668. doi: 10.1093/jnci/djx250.
- Background: PubMed 22829446Hinds PS, Nuss SL, Ruccione KS, Withycombe JS, Jacobs S, DeLuca H, Faulkner C, Liu Y, Cheng YI, Gross HE, Wang J, DeWalt DA. PROMIS pediatric measures in pediatric oncology: valid and clinically feasible indicators of patient-reported outcomes. Pediatr Blood Cancer. 2013 Mar;60(3):402-8. doi: 10.1002/pbc.24233. Epub 2012 Jul 24.
- Background: PubMed 11932914Varni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P. The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer. 2002 Apr 1;94(7):2090-106. doi: 10.1002/cncr.10428.
- Derived from this study: PubMed 40811761Yan AP, Dupuis LL, Aftandilian C, Agarwal V, Baggott C, Beauchemin MP, Bradfield SM, Cannone D, Caywood EH, Crellin-Parsons N, Demedis J, Dickens D, Esbenshade AJ, Freyer DR, Grimes AC, Kelly KM, King AA, Klesges LM, Kyono W, Nagasubramanian R, Orgel E, Orsey AD, Roth ME, Sherani F, Vettese E, Walsh A, Woods-Swafford W, Yu LC, Tomlinson GA, Sung L. Factors Associated With Symptom Burden Among Pediatric Patients With Cancer. JCO Oncol Pract. 2026 Jun;22(6):1087-1095. doi: 10.1200/OP-25-00244. Epub 2025 Aug 14.
- Derived from this study: PubMed 40686265Dupuis LL, Vettese E, Aftandilian C, Agarwal V, Baggott C, Bradfield SM, Crellin-Parsons N, Freyer DR, Kelly KM, King AA, Kyono W, Nagasubramanian R, Orgel E, Roth ME, Sherani F, Yu L, Grimes AC, Beauchemin MP, Klesges LM, Tomlinson GA, Sung L. Factors Associated With Self-Report Symptom Screening Adherence in Pediatric Cancer Patients. Cancer Med. 2025 Jul;14(14):e71053. doi: 10.1002/cam4.71053.
- Derived from this study: PubMed 39535768Dupuis LL, Vettese E, Grimes AC, Beauchemin MP, Klesges LM, Baggott C, Demedis J, Aftandilian C, Freyer DR, Crellin-Parsons N, Orgel E, Dickens D, Kelly KM, Kyono W, Walsh A, Sherani F, Cannone D, Orsey AD, King AA, Yu L, Woods-Swafford W, Bradfield SM, Roth ME, Esbenshade AJ, Caywood EH, Agarwal V, Nagasubramanian R, Tomlinson GA, Sung L. Symptom Screening Linked to Care Pathways for Pediatric Patients With Cancer: A Randomized Clinical Trial. JAMA. 2024 Dec 17;332(23):1981-1991. doi: 10.1001/jama.2024.19585.
- Derived from this study: PubMed 37069510Vettese E, Sherani F, King AA, Yu L, Aftandilian C, Baggott C, Agarwal V, Nagasubramanian R, Kelly KM, Freyer DR, Orgel E, Bradfield SM, Kyono W, Roth M, Klesges LM, Beauchemin M, Grimes A, Tomlinson G, Dupuis LL, Sung L. Symptom management care pathway adaptation process and specific adaptation decisions. BMC Cancer. 2023 Apr 17;23(1):350. doi: 10.1186/s12885-023-10835-0.
- Derived from this study: PubMed 33398260Dupuis LL, Grimes A, Vettese E, Klesges LM, Sung L. Readiness to Implement Symptom Management Care Pathways in Pediatric Cancer. Res Sq [Preprint]. 2020 Dec 30:rs.3.rs-136225. doi: 10.21203/rs.3.rs-136225/v1.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lillian Sung, MD, PhD principal investigator
The Hospital for Sick Children
Laura Lee Dupuis, RPh, PhD principal investigator
The Hospital for Sick Children
Allison Grimes, MD principal investigator
The University of Texas Health Science Center at San Antonio
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPARK Symptom Screening Linked to Feedback to Providers in people with Pediatric Cancer and Quality of Life, run by The Hospital for Sick Children at 21 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Screening in Pediatrics Tool (SSPedi) Total Score (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04614662, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.