CancerNCT04275102
Three Times Weekly Symptom Screening for Children With Cancer
A study testing SPARK in people with Cancer and Relapsed Cancer, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
This study will evaluate the feasibility of three times weekly symptom reporting by children using the SPARK platform for 8 weeks. SPARK is a web-based application that promotes symptom screening for children receiving cancer therapies and enables access to clinical practice guidelines for symptom management. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Cancer, Relapsed Cancer
- What is being tested?
- SPARK
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2025to 29 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- cancer diagnosis
- 2-18 years of age at enrollment
- Child has received or a plan for any chemotherapy, radiotherapy or surgery
- Understands English, French or Spanish
Who cannot join
- Cognitive disability
- Visual impairment (cannot see SPARK even with corrective lens)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Feasibility Study of Three Times Weekly Symptom Screening for Children With Cancer
This study will evaluate the feasibility of three times weekly symptom reporting by children using the SPARK platform for 8 weeks. SPARK is a web-based application that promotes symptom screening for children receiving cancer therapies and enables access to clinical practice guidelines for symptom management. Newly diagnosed and relapsed patients with cancer will be enrolled. Children and/or their guardian will be prompted to complete symptom screening three times weekly via SPARK with corresponding feedback sent to their healthcare providers with each completed assessment. Symptom reports will contain links to clinical practice guidelines for symptom management. Active intervention will last for 8 weeks starting from the date of enrollment.
Read the detailed description
Primary objective is to determine the feasibility of three times weekly symptom reporting by guardians and children using the SPARK platform for 8 weeks. Feasibility will be evaluated by compliance with symptom screening and the investigators anticipate that at least 75% can achieve compliance with at least 60% of symptom evaluations.
Newly diagnosed and relapsed patients with cancer 2-18 years of age will be enrolled Children will be prompted to complete symptom screening three times weekly via SPARK with corresponding feedback sent to their healthcare providers with each completed assessment. Symptom reports will contain links to clinical practice guidelines for symptom management. Active intervention will last for 8 weeks starting from the date of enrollment.
Patient-reported outcomes will be obtained at baseline, and weeks 4, and 8. These outcomes will include the Symptom Screening in Pediatrics Tool (SSPedi), Fatigue will be measured using PROMIS, and the Pediatric Quality of Life Inventory (PedsQL) 3.0 Acute Cancer Module. Data from health records will be abstracted for all enrolled participants to evaluate symptom documentation and intervention provision at times symptom screening is completed as well as emergency room visits, clinic visits and hospitalizations.
Analyses are descriptive. The investigators' primary outcome is feasibility, sample size justification will focus on having sufficient number of guardians and children to optimize study processes and to describe the number of completed symptom assessments. The investigators will enroll up to 20-30 children per site per cohort; it is anticipated the investigators can enroll this number over one year. The 95% confidence intervals assuming 60% compliance will be 36-81% and 41-77% for 20 and 30 participants respectively; this precision is adequate for research purposes. If it is found that the processes are not feasible, the data will be reviewed after the initial cohort and enact refined procedures to rectify the identified problems. In this case enrollment of another 20-30 children per site per cohort with the updated procedures for a total sample size of 40-60 participants per site.
Primary objective of feasibility of responsive respondent type will be to evaluate the feasibility of eliciting bothersome symptoms using co-SSPedi, mini-SSPedi, co-mini-SSPedi, SSPedi or proxy-SSPedi. We will include children with cancer who: (1) are 2-18 years of age at enrollment; (2) are English, French or Spanish speaking (SSPedi is validated in these languages); (3) have any cancer diagnosis regardless of relapse status (4) have received or have a plan to receive any chemotherapy, radiotherapy or surgery. Exclusion criteria will be cognitive disability or visual impairment (cannot see SPARK even with corrective lens).
The same procedures as above will be followed with the exception that 1) PRO outcomes will be PROMIS Fatigue, PROMIS Pain Interference, the Pediatric Nausea Assessment Tool and SSPedi; 2) A qualitative feedback interview will be administered at week 4 and week 8. 3) At each reminder to complete symptom screening, the participant can choose which type of SSPedi they wish to complete. We will track type of SSPedi used. Participants may be contacted in person, by email, text, or over the phone to ensure there are no technical barriers to completing SSPedi.
All statistics are descriptive. As our primary outcome is feasibility, sample size justification will focus on having sufficient number of children to optimize study processes and to describe the number of completed symptom assessments. We will enroll 20-30 children per site per cohort and anticipate we can enroll this number over one year. The 95% confidence intervals assuming 60% compliance will be 36-81% and 41-77% for 20 and 30 participants respectively; this precision is adequate for our purposes. If we find that our processes are not feasible we will review the data after the initial cohort and enact refined procedures to rectify the identified problems. In this case we will enroll another 20-30 children per site per cohort with the updated procedures for a total sample size of 40-60 participants per site.
The sample size calculation for the responsive respondent component will be the same as for the SSPedi feasibility study .
- Conditions
- Cancer, Relapsed Cancer
- Being tested
- SPARK
- Medical subject headings
- Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPARKOther
Prompt to complete symptom screening three times weekly via SPARK with corresponding feedback sent to healthcare providers with each completed assessment.
| Study group | Role | What they receive |
|---|---|---|
| Three times weekly symptom screening | Experimental | Three times weekly symptom reporting by guardians and children using the SPARK platform for 8 weeks Receives: Other: SPARK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of three times weekly symptom reporting by children using the SPARK platform for 8 weeks.
The primary endpoint is feasibility, defined as at least 75% achieving compliance with at least 60% of symptom evaluations among guardian and self-report populations.
Measured: 8 weeks
Secondary outcomes (7)
Symptom burden as measured by the total SSPedi score Total SSPedi symptom scores
Total SSPedi symptom which is the sum of each of the 15 SSPedi item's Likert scores, resulting in a total score that ranges from 0 (no bothersome symptoms) to 60 (worst bothersome symptoms). The recall period is yesterday or today (SSPedi).
Measured: Baseline and weeks 4, and 8
QoL will be measured using the PedsQL 3.0 Acute Cancer Module
Quality of life will be measured using the Pediatric Quality of Life Inventory (PedsQL) 3.0 Acute Cancer Module. 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.
Measured: Baseline and weeks 4, and 8
Symptom documentation
Symptom documentation and intervention provision at each time point in which symptom assessment is performed will be abstracted from the health record.
Measured: Baseline and weeks 4, and 8
Number of Patients' Emergency Department Visits, Unplanned Clinic Visits and Hospitalizations over the 8-week intervention
The number of emergency department visits and unplanned clinic visits and hospitalizations over the 8-week intervention period will be abstracted from the health record.
Measured: Baseline and weeks 4, and 8
Fatigue
Fatigue will be measured using PROMIS. The recall period is the last 7 days. It is reliable and valid in children 5-18 years of age with cancer
Measured: Baseline and weeks 4, and 8
Nausea as measured by the Pediatric Nausea Assessment Tool
The recall period is today and yesterday. It is valid in children 4 to 18.
Measured: Baseline and weeks 4, and 8
Pain as measured by PROMIS Pain Interference
The recall period is the last 7 days. It is reliable and valid in children 5-18 years of age with cancer
Measured: Baseline and weeks 4, and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start1 Aug 2025 (estimated)
- Primary completion29 Nov 2025 (estimated)
- Study completion29 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lillian Sung, The Hospital for Sick Children
- Investigators
- Lillian Sung, MD, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275102
- Sponsor's protocol ID
- REB# 1000063548
- Status last verified
- May 2025
- First submitted
- 11 Dec 2019
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Three Times Weekly Symptom Screening for Children With Cancer
- ClinicalTrials.gov ID
- NCT04275102
- Acronym / sponsor ID
- REB# 1000063548
- Conditions
- Cancer, Relapsed Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 29 Nov 2025 (estimated)
- Study completion
- 29 Nov 2025 (estimated)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the feasibility of three times weekly symptom reporting by children using the SPARK platform for 8 weeks. SPARK is a web-based application that promotes symptom screening for children receiving cancer therapies and enables access to clinical practice guidelines for symptom management. Newly diagnosed and relapsed patients with cancer will be enrolled. Children and/or their guardian will be prompted to complete symptom screening three times weekly via SPARK with corresponding feedback sent to their healthcare providers with each completed assessment. Symptom reports will contain links to clinical practice guidelines for symptom management. Active intervention will last for 8 weeks starting from the date of enrollment.
Detailed description
Primary objective is to determine the feasibility of three times weekly symptom reporting by guardians and children using the SPARK platform for 8 weeks. Feasibility will be evaluated by compliance with symptom screening and the investigators anticipate that at least 75% can achieve compliance with at least 60% of symptom evaluations.
Newly diagnosed and relapsed patients with cancer 2-18 years of age will be enrolled Children will be prompted to complete symptom screening three times weekly via SPARK with corresponding feedback sent to their healthcare providers with each completed assessment. Symptom reports will contain links to clinical practice guidelines for symptom management. Active intervention will last for 8 weeks starting from the date of enrollment.
Patient-reported outcomes will be obtained at baseline, and weeks 4, and 8. These outcomes will include the Symptom Screening in Pediatrics Tool (SSPedi), Fatigue will be measured using PROMIS, and the Pediatric Quality of Life Inventory (PedsQL) 3.0 Acute Cancer Module. Data from health records will be abstracted for all enrolled participants to evaluate symptom documentation and intervention provision at times symptom screening is completed as well as emergency room visits, clinic visits and hospitalizations.
Analyses are descriptive. The investigators' primary outcome is feasibility, sample size justification will focus on having sufficient number of guardians and children to optimize study processes and to describe the number of completed symptom assessments. The investigators will enroll up to 20-30 children per site per cohort; it is anticipated the investigators can enroll this number over one year. The 95% confidence intervals assuming 60% compliance will be 36-81% and 41-77% for 20 and 30 participants respectively; this precision is adequate for research purposes. If it is found that the processes are not feasible, the data will be reviewed after the initial cohort and enact refined procedures to rectify the identified problems. In this case enrollment of another 20-30 children per site per cohort with the updated procedures for a total sample size of 40-60 participants per site.
Primary objective of feasibility of responsive respondent type will be to evaluate the feasibility of eliciting bothersome symptoms using co-SSPedi, mini-SSPedi, co-mini-SSPedi, SSPedi or proxy-SSPedi. We will include children with cancer who: (1) are 2-18 years of age at enrollment; (2) are English, French or Spanish speaking (SSPedi is validated in these languages); (3) have any cancer diagnosis regardless of relapse status (4) have received or have a plan to receive any chemotherapy, radiotherapy or surgery. Exclusion criteria will be cognitive disability or visual impairment (cannot see SPARK even with corrective lens).
The same procedures as above will be followed with the exception that 1) PRO outcomes will be PROMIS Fatigue, PROMIS Pain Interference, the Pediatric Nausea Assessment Tool and SSPedi; 2) A qualitative feedback interview will be administered at week 4 and week 8. 3) At each reminder to complete symptom screening, the participant can choose which type of SSPedi they wish to complete. We will track type of SSPedi used. Participants may be contacted in person, by email, text, or over the phone to ensure there are no technical barriers to completing SSPedi.
All statistics are descriptive. As our primary outcome is feasibility, sample size justification will focus on having sufficient number of children to optimize study processes and to describe the number of completed symptom assessments. We will enroll 20-30 children per site per cohort and anticipate we can enroll this number over one year. The 95% confidence intervals assuming 60% compliance will be 36-81% and 41-77% for 20 and 30 participants respectively; this precision is adequate for our purposes. If we find that our processes are not feasible we will review the data after the initial cohort and enact refined procedures to rectify the identified problems. In this case we will enroll another 20-30 children per site per cohort with the updated procedures for a total sample size of 40-60 participants per site.
The sample size calculation for the responsive respondent component will be the same as for the SSPedi feasibility study .
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Three times weekly symptom screening | Experimental | Other: SPARKThree times weekly symptom reporting by guardians and children using the SPARK platform for 8 weeks |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- cancer diagnosis
- 2-18 years of age at enrollment
- Child has received or a plan for any chemotherapy, radiotherapy or surgery
- Understands English, French or Spanish
Key exclusion criteria (2 listed)
- Cognitive disability
- 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 |
|---|---|---|
| SPARKPrompt to complete symptom screening three times weekly via SPARK with corresponding feedback sent to healthcare providers with each completed assessment. | Other | Three times weekly symptom screening |
Primary outcome
Feasibility of three times weekly symptom reporting by children using the SPARK platform for 8 weeks.
Time frame: 8 weeks
The primary endpoint is feasibility, defined as at least 75% achieving compliance with at least 60% of symptom evaluations among guardian and self-report populations.
7 secondary outcomes
Symptom burden as measured by the total SSPedi score Total SSPedi symptom scores
Time frame: Baseline and weeks 4, and 8
QoL will be measured using the PedsQL 3.0 Acute Cancer Module
Time frame: Baseline and weeks 4, and 8
Symptom documentation
Time frame: Baseline and weeks 4, and 8
Number of Patients' Emergency Department Visits, Unplanned Clinic Visits and Hospitalizations over the 8-week intervention
Time frame: Baseline and weeks 4, and 8
Fatigue
Time frame: Baseline and weeks 4, and 8
Nausea as measured by the Pediatric Nausea Assessment Tool
Time frame: Baseline and weeks 4, and 8
Pain as measured by PROMIS Pain Interference
Time frame: Baseline and weeks 4, and 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: No
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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.
Lillian Sung, MD, PhD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPARK in people with Cancer and Relapsed Cancer, run by The Hospital for Sick Children at 1 site in Canada.
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 4 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: opening soon, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Lillian Sung (4168135287, lillian.sung@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of three times weekly symptom reporting by children using the SPARK platform for 8 weeks. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2025.