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
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Cancer Quality of Life||Behavioral: SPARK Symptom Screening Linked to Feedback to Providers||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||444 participants|
|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|
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.
- 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)
- 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)
- 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)
- 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.
- 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.
- 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.
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
|Contact: Lillian Sung, MD, PhDfirstname.lastname@example.org|
|Contact: Emily Vettese||416-813-7654 ext email@example.com|
|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|