Official Title
Symptom Screening Linked to Care Pathways for Children With Cancer: a Cluster Randomized Trial
Summary:
Most children with cancer survive because they are given intensive treatments, but
unfortunately, these treatments are associated with distressing symptoms. To address this
problem, we developed the Symptom Screening in Pediatrics Tool (SSPedi) so that children
receiving cancer treatments can communicate their bothersome symptoms, and Supportive care
Prioritization, Assessment and Recommendations for Kids (SPARK), a web-based application that
links identified symptoms to supportive care guidelines for symptom management. To establish
that these tools improve the lives of children newly diagnosed with cancer, we will conduct a
trial that randomizes 20 pediatric cancer institutions and measures the impact of three times
weekly symptom screening, symptom feedback to healthcare providers and the development of
care pathways for symptom management to improve total symptom burden, fatigue and quality of
life.
Trial Description
Primary Outcome:
- Symptom Screening in Pediatrics Tool (SSPedi) total score
Secondary Outcome:
- Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Bank v2.0 - Fatigue
- PedsQL 3.0 Acute Cancer Module
- Documentation of symptoms
- Provision of interventions for symptoms
- Number of emergency department visits and unplanned clinic visits and hospitalizations
Aims 1 and 2: Among children with newly diagnosed cancer, to determine if symptom screening
and feedback to healthcare providers at least three times weekly and locally-adapted symptom
management care pathways, when compared to usual care:
Aim 1. Improves overall self-reported symptom scores (total SSPedi score), fatigue
(PROMIS-Fatigue) and cancer-specific QoL (PedsQL 3.0 Acute Cancer Module) over 8 weeks
Hypothesis: Symptom screening and care pathways will improve symptoms, fatigue and QoL
Aim 2. Improves symptom documentation, increases provision of interventions for symptoms, and
reduces emergency department visits and unplanned clinic visits and hospitalizations over 8
weeks Hypotheses: Symptom screening and care pathways will increase symptom documentation and
provision of interventions for symptoms, and will reduce healthcare utilization.
Aim 3: As an exploratory aim, we will evaluate key elements of the intervention related to
the external validity and generalizability of the intervention effects using the RE-AIM
framework.
Overall Strategy This is a cluster randomized trial including 20 pediatric oncology sites.
The coordinating centre is The Hospital for Sick Children in Toronto, Canada. Sites will be
randomized to either systematic symptom screening via SPARK with provision of symptom reports
to healthcare providers containing links to care pathways for symptom management
(intervention) or usual care (control).
Research Methods Eligibility: We will include children with cancer who: (1) are 8-18 years of
age at enrollment (SSPedi is validated in this age range); (2) are English or
Spanish-speaking (all PROs are validated in these languages in this age range); (3) have any
newly diagnosed cancer; (4) have a plan for any chemotherapy, radiation therapy or surgery; and
(5) enroll within 28 days after treatment initiation. Exclusion criteria will be cognitive
disability (attending lower than second grade or equivalent) or visual impairment (cannot see
SPARK even with corrective lens).
Procedures: In this cluster randomized trial, we will randomize sites to either intervention
or control groups. At both intervention and control sites, we will enroll participants within
28 days after treatment initiation. Eligible participants will be identified by site
personnel and the study will be explained to them by trained research team members.
Participant capacity to consent will be assessed by the clinical or research team according
to institutional standards. After the study has been explained and sufficient time has been
provided to ensure all questions have been answered, informed consent and assent will be
obtained from participants and guardians as appropriate. For those who decline to contribute
PROs, they will be given the option to only participate in a retrospective chart review to
evaluate symptom documentation, intervention provision and healthcare utilization. Careful
tracking of all newly diagnosed patients by site research personnel will occur to determine
how many patients are approached and consented, and where possible, reasons for declining
participation.
For all enrolled participants who will be contributing PROs (excluding those only involved in
the retrospective chart review), a personal SPARK account will be created to allow SSPedi to
be completed and symptom results to be recorded. At the 10 intervention sites, site-specific
symptom management care pathways will be adapted from template care pathways for each of the
15 symptoms included in SSPedi. Enrolled participants will be prompted by text or email to
complete symptom screening three times weekly via SPARK with corresponding feedback sent to
their healthcare providers. Symptom reports will contain links to care pathways for symptom
management. Active intervention will last for eight weeks starting from the date of
enrollment. At the 10 control sites, participants will complete SSPedi to obtain the primary
outcome at weeks 0, 4 and 8 but the scores will not be revealed to providers and will not be
linked to care pathways. Usual care will be provided to participants at control sites and
thus, there will be no study-requested routine, systematic symptom screening, symptom
feedback to providers, or linkage to care pathways. If sites already routinely perform
systematic symptom screening or use care pathways for symptom management, these may be
continued but their use will be recorded.
At both intervention and control sites, demographic information including age, sex, race,
ethnicity, diagnosis, cancer stage, family socioeconomic information and treatment plan will
be collected at enrollment. The following PROs will be obtained by trained research staff at
baseline, week 4 and week 8 for all participants: SSPedi, PROMIS Fatigue and the PedsQL 3.0
Acute Cancer Module (Aim 1). We will contact participants ahead of time to coordinate the
week 4 and 8 PROs so that they can be completed in person during hospitalizations or clinic
visits. If unable to arrange completion of these PROs in person, we will use their contact
information to complete the questionnaires by email, text or over the phone. Data from health
records (Aim 2) will be abstracted for all enrolled participants. Relapse and cancer
treatment received information will be collected at the end of the study.
View this trial on ClinicalTrials.gov
