Three Times Weekly Symptom Screening for Children With Cancer

Cancer Clinical Trial

Official title:

A Feasibility Study of Three Times Weekly Symptom Screening for Children With Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04275102
• Other study ID #: REB# 1000063548
• Status: Completed
• Phase: N/A
• Start date: January 24, 2020
• Est. completion date: February 8, 2022

Study information

• Verified date: June 2022
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the feasibility of three times weekly symptom reporting by children using the SPARK platform for 8 weeks. SPARK is a web-based application that promotes symptom screening for children receiving cancer therapies and enables access to clinical practice guidelines for symptom management. Newly diagnosed and relapsed patients with cancer 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 8, 2022
• Est. primary completion date: January 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• cancer diagnosis

• 8-18 years of age at enrollment

• Child has received or a plan for any chemotherapy, radiotherapy or surgery

• Understands English or Spanish

Exclusion Criteria:

• Cognitive disability

• Visual impairment (cannot see SPARK even with corrective lens)

Related Conditions & MeSH terms

• Cancer
• Relapsed Cancer

Intervention

Other:
• SPARK
Prompt to complete symptom screening three times weekly via SPARK with corresponding feedback sent to healthcare providers with each completed assessment.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of three times weekly symptom reporting by children using the SPARK platform for 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.	8 weeks
Secondary	Symptom burden as measured by the total SSPedi score Total SSPedi symptom scores	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).	Baseline and weeks 4, and 8
Secondary	QoL will be measured using the PedsQL 3.0 Acute Cancer Module	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.	Baseline and weeks 4, and 8
Secondary	Symptom documentation	Symptom documentation and intervention provision at each time point in which symptom assessment is performed will be abstracted from the health record.	Baseline and weeks 4, and 8
Secondary	Number of Patients' Emergency Department Visits, Unplanned Clinic Visits and Hospitalizations over the 8-week intervention	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.	Baseline and weeks 4, and 8
Secondary	Fatigue	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	Baseline and weeks 4, and 8