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Symptom Screening Linked to Care Pathways

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ClinicalTrials.gov Identifier: NCT04614662
Recruitment Status : Recruiting
First Posted : November 4, 2020
Last Update Posted : June 16, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Lillian Sung, The Hospital for Sick Children

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.

Condition or disease Intervention/treatment Phase
Pediatric Cancer Quality of Life Behavioral: SPARK Symptom Screening Linked to Feedback to Providers Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 444 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster Randomized Trial
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Symptom Screening Linked to Care Pathways for Children With Cancer: a Cluster Randomized Trial
Actual Study Start Date : August 2, 2021
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2025

Arm Intervention/treatment
Experimental: Intervention

Participants enrolled at intervention sites will be prompted to complete symptom screening three times weekly via SPARK with corresponding feedback and links to symptom management care pathways sent to their healthcare providers.

Symptom screening using SPARK can be performed at any time and as often as desired, but screening will be prompted three times weekly for eight weeks.

Each day the participant completes symptom screening and has at least one severely bothersome symptom, the primary healthcare team will receive an email summarizing the symptom report and highlighting symptoms that are "a lot" or "extremely" bothersome.

Upon study activation, we will work with each of the 10 intervention sites to develop site-specific, adapted care pathways that consider relevant work flows, institutional culture and available resources.

Behavioral: SPARK Symptom Screening Linked to Feedback to Providers
Symptom screening three times weekly via SPARK, feedback of symptoms to healthcare providers and development of care pathways for symptom management.

No Intervention: Control
At control sites, usual care will be provided, which may or may not include symptom screening, access to CPGs or care pathways. 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.



Primary Outcome Measures :
  1. Symptom Screening in Pediatrics Tool (SSPedi) total score [ Time Frame: Week 8 ]
    SSPedi measures the degree to which 15 symptoms bothered the participant yesterday or today. Each symptom is scored on a 5-point Likert scale ranging from 0 (not at all bothered) to 4 (extremely bothered). The total score ranges from 0 to 60 where higher numbers indicate more bothersome symptoms. The total SSPedi score is reliable, valid and responsive to change in children with cancer 8-18 years of age.(1)


Secondary Outcome Measures :
  1. Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Bank v2.0 - Fatigue [ Time Frame: Week 8 ]
    Fatigue will be measured using PROMIS. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation of that population. The recall period is the last 7 days and a higher score equals more fatigue. It is reliable and valid in children 8-18 years of age with cancer.(2)

  2. PedsQL 3.0 Acute Cancer Module [ Time Frame: Week 8 ]
    This is a cancer-specific measure of quality of life. 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 minimum value on the scale is 0 and maximum value is 100. PedsQL uses reverse scoring thus a higher score indicates a better outcome. This measure is a multidimensional instrument that is reliable and valid in children with cancer.(3)

  3. Documentation of symptoms [ Time Frame: Week 8 ]
    Documentation of symptoms will be abstracted from the patients' health records. This outcome will be obtained with a one day window before and after the week 8 patient-reported outcome assessment.

  4. Provision of interventions for symptoms [ Time Frame: Week 8 ]
    The number of interventions for each symptom at each reporting period will be recorded and categorized as any intervention provided vs. no intervention provided. Interventions included in the local care pathway will be noted. This outcome will be obtained with a one day window after the week 8 patient-reported outcome assessment.

  5. Number of emergency department visits and unplanned clinic visits and hospitalizations [ Time Frame: 8 weeks ]
    Number of visits to the emergency room and unplanned clinic visits and hospitalizations will be summed over the 8 week on-study period.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04614662


Contacts
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Contact: Lillian Sung, MD, PhD 416-813-5287 lillian.sung@sickkids.ca
Contact: Emily Vettese 416-813-7654 ext 301592 emily.vettese@sickkids.ca

Locations
Show Show 21 study locations
Sponsors and Collaborators
The Hospital for Sick Children
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Lillian Sung, MD, PhD The Hospital for Sick Children
Principal Investigator: Laura Lee Dupuis, RPh, PhD The Hospital for Sick Children
Principal Investigator: Allison Grimes, MD The University of Texas Health Science Center at San Antonio
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lillian Sung, Pediatric Oncologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT04614662    
Other Study ID Numbers: 1000068699
1R01CA251112-01 ( U.S. NIH Grant/Contract )
PJT-169165 ( Other Grant/Funding Number: Canadian Institutes of Health Research (CIHR) )
First Posted: November 4, 2020    Key Record Dates
Last Update Posted: June 16, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The full data set including the patient-reported outcome data will be available publically following trial completion after ensuring that no patient can be identified and no disclosure of personal health information. The data will become available no later than one year after the primary publication and will be available for at least five years.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Five years
Access Criteria: Upon request to, and approval by the study team

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lillian Sung, The Hospital for Sick Children:
Pediatric Oncology
Cluster Randomized Clinical Trial
Symptom Screening
Quality of Life