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Completed

NCT Number: NCT03593525

SPARK Symptom Screening 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

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Key information

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lillian Sung

Toronto, Ontario, M5G 1X8, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPARK

Other

see above

Primary outcomes

  1. SSPedi (Symptom Screening in Pediatrics) Total Scores

    Time frame: Measure will be completed by all participants at baseline (day 1) and 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).

Secondary outcomes

  1. Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom

    Time frame: Measure will be completed by all participants on baseline (day 1) and day 5±1 day.

    The subscale SSPedi score is a validated measure that reflects the burden of a bothersome symptom experienced. Each of the 15 symptoms assessed by the SSPedi questionnaire will serve as secondary outcomes. The subscale uses a Likert score that ranges from 0 (not at all bothered) to 4 (extremely bothered). The reported values represent the number of participants who had symptoms rated as severely bothersome, defined as a score of 3 or 4 on the subscale. Higher reported scores indicate a higher number of participants that reported the level of bother for that symptom as a 3 or a 4.

  2. Faces Pain Scale-Revised

    Time frame: Measure will be completed by all participants on day 1 (baseline) and 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.

  3. PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module

    Time frame: Measure will be completed by all participants on day 1 (baseline) and 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. They produce 8 domain scores ranging from 0 to 100, with higher scores denote better health.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

A Randomized Controlled Trial of Symptom Screening by Children With Cancer and Feedback to Providers

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jul 20, 2018
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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