SPARK Symptom Screening and Feedback to Providers

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03593525
• Other study ID #: REB: 000061139
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: September 17, 2023

Study information

• Verified date: November 2023
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: September 17, 2023
• Est. primary completion date: September 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Oncology
• Quality of Life

Intervention

Other:
• SPARK
see above

Locations

Country	Name	City	State
Canada	Lillian Sung	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SSPedi (Symptom Screening in Pediatrics) Total Scores	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	Self-reported individual SSPedi (Symptom Screening in Pediatrics) symptom	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
Secondary	Faces Pain Scale-Revised	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
Secondary	PedsQL (pediatric Quality of Life) 3.0 Acute Cancer Module	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