- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03593525
SPARK Symptom Screening and Feedback to Providers
November 3, 2023 updated by: Lillian Sung, The Hospital for Sick Children
A Randomized Controlled Trial of Symptom Screening by Children With Cancer and Feedback to Providers
Supportive care Prioritization, Assessment and Recommendations for Kids (SPARK) is a web-based application which builds upon the Symptom Screening in Pediatrics Tool (SSPedi) and consists of two components: (1) a symptom screening component centered on SSPedi; and (2) a supportive care clinical practice guideline (CPG) component.
This proposal is a randomized controlled trial that compares daily completion of SSPedi via SPARK for 5 days with symptom feedback to healthcare providers compared with standard of care
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants will be children with cancer or hematopoietic stem cell transplantation (HSCT) recipients who are 8-18 years of age and who can understand English, and who are expected to be in hospital or in clinic daily for 5 days.
This will be a multi-center RCT in which we will randomize children to either undergo daily symptom screening for 5 days with symptom reports provided to the healthcare team or standard of care.
The primary outcome will be the self-reported day 5 total SSPedi score (range 0-60; higher worse).
Secondary outcomes will be the day 5 self-reported individual symptom, pain and QoL scores, and documentation of symptoms and provision of interventions for symptoms over the 5 day trial.
We will enroll 345 participants over 4 years from 7 Canadian centers
Study Type
Interventional
Enrollment (Actual)
345
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X8
- Lillian Sung
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 8 to 18 years of age
- Diagnosis of cancer or have received or about to receive HSCT
- Understand English
- Expected to be in hospital or clinic for 5 day
Exclusion Criteria:
- illness severity
- cognitive disability
- visual impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SPARK Intervention
Participants will complete symptom screening using SPARK once daily on a study-supplied iPad.
For inpatients, daily reminders to complete SSPedi will appear on the iPad.
Reports will be available to the child at any time.
For outpatients, clinical research associates will provide the iPad in person daily and reports may be viewed at those encounters.
The intervention is daily symptom screening with provision of reports to the healthcare team.
Severe symptoms will result in email alerts.
More specifically, SSPedi reports will be printed daily and provided in the patient chart.
On days 1 and 3, an alert will be emailed to the physician providing direct medical care if any symptom is "a lot" or "extremely" bothersome (score 3 or 4 on 0-4 scale).
Reports and alerts will have links to SPARK-housed CPGs.
|
see above
|
No Intervention: Standard of Care Arm
Participants randomized to the control arm will not complete daily symptom screening.
They will complete SSPedi on days 1 and 5 to obtain the primary outcome.
Health care providers will not be notified of their SSPedi scores and no symptom reports or symptom alerts will be generated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SSPedi (Symptom Screening in Pediatrics) Total Scores
Time Frame: Measure will be completed by all participants on day 5±1 day.
|
The primary outcome will be the self-reported total SSPedi score on day 5.
The total SSPedi score is a validated measure that reflects the total burden of bothersome symptoms experienced.
The total score is the sum of each of the 15 items' Likert scores which range from 0 (not at all bothered) to 4 (extremely bothered) to yield a total score that ranges from 0 (no bothersome symptoms) to 60 (worst bothersome symptoms).
|
Measure will be completed by all participants on day 5±1 day.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported individual SSPedi (Symptom Screening in Pediatrics) symptom
Time Frame: Measure will be completed by all participants on day 5±1 day
|
Each of the 15 symptoms included in SSPedi will be secondary outcomes.
(0 not bothered at all to 4 extremely bothersome)
|
Measure will be completed by all participants on day 5±1 day
|
Faces Pain Scale-Revised
Time Frame: Measure will be completed by all participants on day 5±1 day
|
Self-reported pain will be assessed using the Faces Pain Scale-Revised which consists of a series of horizontal faces that depict a neutral facial expression of no pain on the left and worst pain on the right.
It has 6 faces and may be scored on a 0 to 10 scale in which higher numbers denote more pain.
|
Measure will be completed by all participants on day 5±1 day
|
PedsQL (pediatric Quality of Life) 3.0 Acute Cancer Module
Time Frame: Measure will be completed by all participants on day 5±1 day
|
Self-reported QoL will be measured using the PedsQL 3.0 Acute Cancer Module.
This measure is a multidimensional instrument that is reliable and valid in children with cancer.
It assesses pain and hurt, nausea, procedural anxiety, treatment anxiety, worry, cognitive problems, perceived physical appearance and communication.
The self-report 7-day recall version will be used.
The problems are rated from 0; never a problem to 4 if it is almost always a problem.Higher scores denote better health.
|
Measure will be completed by all participants on day 5±1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lillian Sung, MD, The Hospital for Sick Children
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2018
Primary Completion (Actual)
September 16, 2023
Study Completion (Actual)
September 17, 2023
Study Registration Dates
First Submitted
July 10, 2018
First Submitted That Met QC Criteria
July 10, 2018
First Posted (Actual)
July 20, 2018
Study Record Updates
Last Update Posted (Actual)
November 7, 2023
Last Update Submitted That Met QC Criteria
November 3, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- REB: 000061139
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Quality of Life
-
Assiut UniversityUnknownImproving Quality of LifeEgypt
-
B. Braun Medical SAUnknownQuality of Life of Colostomized Patient
-
Children's National Research InstituteRecruitingProfessional Quality of LifeUnited States
-
Istituto Ortopedico RizzoliUniversity of BolognaActive, not recruitingImprove Quality of LifeItaly
-
Mattu UniversityCompletedBreif Description: Patients' Quality of Life ofEthiopia
-
University of South CarolinaNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingHealth Related Quality of LifeUnited States
-
PharmanexSprim Advanced Life SciencesCompletedHealth-related Quality of LifeUnited States
-
Region VästmanlandUnknownHealth Related Quality of Life
-
Ain Shams UniversityCompletedHealth Related Quality of LifeEgypt
-
Institute of Oncology LjubljanaUnknownHealth-related Quality of LifeSlovenia
Clinical Trials on SPARK
-
Karolinska InstitutetLinkoeping University; Region ÖstergötlandRecruitingGestational Diabetes MellitusSweden
-
National Cancer Centre, SingaporeSingapore General Hospital; Duke-NUS Graduate Medical SchoolCompletedHealth Services ResearchSingapore
-
University of MiamiUniversity of TennesseeCompletedObesity | Cognitive Function 1, Social | Physical Fitness
-
The Hospital for Sick ChildrenCompleted
-
Spark Neuro Inc.Recruiting
-
Limbix Health, Inc.Completed
-
Baylor College of MedicineEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedObesity | Motor Activity
-
Limbix Health, Inc.CompletedDepressionUnited States
-
University of WashingtonNational Institute of Neurological Disorders and Stroke (NINDS); Northern Arizona... and other collaboratorsRecruiting
-
Northern Arizona UniversityUniversity of Washington; Gillette Children's Specialty HealthcareRecruiting