Clinical trial NCT04614662: Symptom Screening Linked to Care Pathways
Official title: Symptom Screening Linked to Care Pathways for Children With Cancer: a Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pediatric Cancer
Quality of Life
Keywords: Pediatric Oncology
Cluster Randomized Clinical Trial
Symptom Screening
Quality of Life
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-11-04
Enrollment: 445
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster Randomized Trial
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 8-18 years of age at enrollment
* English or Spanish-speaking
* Any newly diagnosed cancer
* Have a plan for any chemotherapy, radiotherapy or surgery
* Enroll within 28 days after treatment initiation

Exclusion Criteria:

* Cognitive disability (attending minimum second grade or equivalent)
* Visual impairment (cannot see SPARK even with corrective lens)

Primary outcomes:
measure: Symptom Screening in Pediatrics Tool (SSPedi) total score
timeFrame: Week 8
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Bank v2.0 - Fatigue
timeFrame: Week 8
measure: PedsQL 3.0 Acute Cancer Module
timeFrame: Week 8
measure: Documentation of symptoms
timeFrame: Week 8
measure: Provision of interventions for symptoms
timeFrame: Week 8
measure: Number of emergency department visits and unplanned clinic visits and hospitalizations
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Redwood City
country: United States
facility: The Leland Stanford Junior University
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Wilmington
country: United States
facility: Nemours Children's Hospital, Delaware
state: Delaware
city: Jacksonville
country: United States
facility: Nemours Children's Health, Jacksonville
state: Florida
city: Orlando
country: United States
facility: Nemours Children's Hospital, Florida
state: Florida
city: Honolulu
country: United States
facility: Kapi'olani Medical Center for Women & Children
state: Hawaii
city: Des Moines
country: United States
facility: Unity Point Health - Blank Children's Hospital
state: Iowa
city: Iowa City
country: United States
facility: The University of Iowa
state: Iowa
city: New Orleans
country: United States
facility: Children's Hospital
state: Louisiana
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
city: New York
country: United States
facility: The Trustees of Columbia University in the City of New York
state: New York
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Corpus Christi
country: United States
facility: Driscoll Children's Hospital
state: Texas
city: Houston
country: United States
facility: The University of Texas M. D. Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Lillian Sung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital for Sick Children
name: Laura Lee Dupuis, RPh, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center at San Antonio
name: Allison Grimes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dupuis LL, Johnston DL, Baggott C, Hyslop S, Tomlinson D, Gibson P, Orsey A, Dix D, Price V, Vanan M, Portwine C, Kuczynski S, Spiegler B, Tomlinson GA, Sung L. Validation of the Symptom Screening in Pediatrics Tool in Children Receiving Cancer Treatments. J Natl Cancer Inst. 2018 Jun 1;110(6):661-668. doi: 10.1093/jnci/djx250.
citation: Hinds PS, Nuss SL, Ruccione KS, Withycombe JS, Jacobs S, DeLuca H, Faulkner C, Liu Y, Cheng YI, Gross HE, Wang J, DeWalt DA. PROMIS pediatric measures in pediatric oncology: valid and clinically feasible indicators of patient-reported outcomes. Pediatr Blood Cancer. 2013 Mar;60(3):402-8. doi: 10.1002/pbc.24233. Epub 2012 Jul 24.
citation: Varni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P. The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer. 2002 Apr 1;94(7):2090-106. doi: 10.1002/cncr.10428.
citation: Dupuis LL, Grimes A, Vettese E, Klesges LM, Sung L. Readiness to Implement Symptom Management Care Pathways in Pediatric Cancer. Res Sq [Preprint]. 2020 Dec 30:rs.3.rs-136225. doi: 10.21203/rs.3.rs-136225/v1.