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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03593525
Other study ID # REB: 000061139
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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