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 center 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, radiotherapy 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.
