Clinical trial NCT03495518: Enabling Symptom Identification and Tracking in Children Receiving Cancer Treatment
Official title: Refinement and Early Evaluation of SPARK, an Approach to Enable Symptom Screening and Monitoring by Children Receiving Cancer Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Cancer
Quality of Life
Symptom Screening
Keywords: Cancer
Randomized Control Trial
Children
Hematopoietic stem cell transplantation
Quality of Life
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2018-04-12
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Children with cancer and hematopoietic stem cell transplant (HSCT) recipients suffer from severe and bothersome symptoms because treatments are intense. So, the investigators developed SPARK (Supportive care Prioritization, Assessment and Recommendations for Kids), a website devoted to helping children track symptoms and providing a way to let doctors and nurses know which symptoms are bothersome. This study will examine the likelihood that children will complete SPARK once daily, help the investigators figure out how to improve the website so that children will use it, and help the investigators plan the large scale trial to test its efficacy in improving quality of life (QoL).

Participants will be children with cancer or HSCT recipients who are 8-18 years of age and who are expected to be in hospital or in clinic daily for 5 days.To determine the feasibility of a randomized controlled trial (RCT) of symptom feedback to healthcare providers

Detailed description: Methods: Participants will be children with cancer or 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.

SPARK RCT will be a pilot 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. Feasibility will be met if at least 30 participants are enrolled within one year and at least 75% complete at least 60% of evaluations.

Quality of the Idea Children receiving cancer treatment have excellent survival outcomes, in part, related to the provision of intensive therapies. Unfortunately, most children suffer and experience severe and bothersome treatment-related symptoms. Symptoms not only impact on QoL and morbidity but, in addition, may negatively influence future psychosocial functioning.

Symptoms remain unaddressed even during healthcare encounters because children do not complain and clinicians fail to ask about them. We recently developed SSPedi, a pediatric-specific symptom screening tool on an iPad. SSPedi, however, consists only of the questions which ask about symptoms. SPARK is the web-based application which will facilitate access to SSPedi, encourage symptom screening, generate reports and allow children to track their symptoms. Careful thought to design is required to ensure SPARK optimizes future use and has clinical utility. The proposed project output is a product that facilitates longitudinal symptom screening and provides the groundwork for a future RCT of symptom feedback.

Eligibility criteria: Inclusion Criteria:

* We will include children with cancer and HSCT recipients who are 8-18 years of age at enrollment and who can understand English.
* Participants may be inpatients or outpatients, and may be actively receiving cancer treatment or may have completed treatment.

Exclusion Criteria:

* Exclusion criteria will be illness severity, cognitive disability, or visual impairment that precludes utilization of SPARK according to the healthcare team.

Primary outcomes:
measure: Feasibility of an RCT of symptom feedback to healthcare providers versus standard of care
timeFrame: Study will be enrolling for 1 year with a goal to enroll 30 participants. Feasibility will be determined once all 30 participants have completed the study after 1 year
Secondary outcomes:
measure: Pediatric Quality of Life (Peds QL) Cancer Module Acute Version
timeFrame: Measure will be completed by participant on day 5±1 day.
measure: Symptom Screening in Pediatrics (SSPedi)
timeFrame: Those randomized to the intervention arm measure will be completed by participant every day for 5 days. Those randomized to control arm measure will be completed by participant on Days 1 and 5±1 day.
measure: Faces Pain Scale Revised
timeFrame: Measure will be completed on day 5±1 day.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital For SickKids
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Lillian Sung, MD
role: PRINCIPAL_INVESTIGATOR
References: