Three Times Weekly Symptom Screening for Children With Cancer
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|ClinicalTrials.gov Identifier: NCT04275102|
Recruitment Status : Completed
First Posted : February 19, 2020
Last Update Posted : June 7, 2022
|Condition or disease||Intervention/treatment||Phase|
|Cancer Relapsed Cancer||Other: SPARK||Not Applicable|
Primary objective is to determine the feasibility of three times weekly symptom reporting by guardians and children using the SPARK platform for 8 weeks. Feasibility will be evaluated by compliance with symptom screening and the investigators anticipate that at least 75% can achieve compliance with at least 60% of symptom evaluations.
Newly diagnosed and relapsed patients with cancer 8-18 years of age will be enrolled Children will be prompted to complete symptom screening three times weekly via SPARK with corresponding feedback sent to their healthcare providers with each completed assessment. Symptom reports will contain links to clinical practice guidelines for symptom management. Active intervention will last for 8 weeks starting from the date of enrollment.
Patient-reported outcomes will be obtained at baseline, and weeks 4, and 8. These outcomes will include the Symptom Screening in Pediatrics Tool (SSPedi), Fatigue will be measured using PROMIS, and the Pediatric Quality of Life Inventory (PedsQL) 3.0 Acute Cancer Module. Data from health records will be abstracted for all enrolled participants to evaluate symptom documentation and intervention provision at times symptom screening is completed as well as emergency room visits, clinic visits and hospitalizations.
Analyses are descriptive. The investigators' primary outcome is feasibility, sample size justification will focus on having sufficient number of guardians and children to optimize study processes and to describe the number of completed symptom assessments. The investigators will enroll up to 20-30 children per site per cohort; it is anticipated the investigators can enroll this number over one year. The 95% confidence intervals assuming 60% compliance will be 36-81% and 41-77% for 20 and 30 participants respectively; this precision is adequate for research purposes. If it is found that the processes are not feasible, the data will be reviewed after the initial cohort and enact refined procedures to rectify the identified problems. In this case enrollment of another 20-30 children per site per cohort with the updated procedures for a total sample size of 40-60 participants per site.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Feasibility Study of Three Times Weekly Symptom Screening for Children With Cancer|
|Actual Study Start Date :||January 24, 2020|
|Actual Primary Completion Date :||January 28, 2022|
|Actual Study Completion Date :||February 8, 2022|
Experimental: Three times weekly symptom screening
Three times weekly symptom reporting by guardians and children using the SPARK platform for 8 weeks
Prompt to complete symptom screening three times weekly via SPARK with corresponding feedback sent to healthcare providers with each completed assessment.
- Feasibility of three times weekly symptom reporting by children using the SPARK platform for 8 weeks. [ Time Frame: 8 weeks ]The primary endpoint is feasibility, defined as at least 75% achieving compliance with at least 60% of symptom evaluations among guardian and self-report populations separately.
- Symptom burden as measured by the total SSPedi score Total SSPedi symptom scores [ Time Frame: Baseline and weeks 4, and 8 ]Total SSPedi symptom which is the sum of each of the 15 SSPedi item's Likert scores, resulting in a total score that ranges from 0 (no bothersome symptoms) to 60 (worst bothersome symptoms). The recall period is yesterday or today (SSPedi).
- QoL will be measured using the PedsQL 3.0 Acute Cancer Module [ Time Frame: Baseline and weeks 4, and 8 ]Quality of life will be measured using the Pediatric Quality of Life Inventory (PedsQL) 3.0 Acute Cancer Module. 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.
- Symptom documentation [ Time Frame: Baseline and weeks 4, and 8 ]Symptom documentation and intervention provision at each time point in which symptom assessment is performed will be abstracted from the health record.
- Number of Patients' Emergency Department Visits, Unplanned Clinic Visits and Hospitalizations over the 8-week intervention [ Time Frame: Baseline and weeks 4, and 8 ]The number of emergency department visits and unplanned clinic visits and hospitalizations over the 8-week intervention period will be abstracted from the health record.
- Fatigue [ Time Frame: Baseline and weeks 4, and 8 ]Fatigue will be measured using PROMIS. The recall period is the last 7 days. It is reliable and valid in children 5-18 years of age with cancer
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): NCT04275102
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G1X8|
|Principal Investigator:||Lillian Sung, MD, PhD||The Hospital for Sick Children|