Three Times Weekly Symptom Screening for Children With Cancer

Official Title

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

Summary:

This study will evaluate the feasibility of three times weekly symptom reporting by guardians and children using the SPARK platform for 12 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 within 28 days after treatment initiation. Guardians, children or both 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 12 weeks starting from the date of enrollment.

Trial Description

Primary Outcome:

• Feasibility

Secondary Outcome:

• Total SSPedi symptom or Mini -SSPedi symptom scores
• Fatigue
• Quality of Life
• Pain as measured by FPS-R
• Symptom documentation
• Number of Patients' Emergency Department Visits, Unplanned Clinic Visits and Hospitalizations over the 12-week intervention

Primary objective is to determine the feasibility of three times weekly symptom reporting by guardians and children using the SPARK platform for 12 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 4-18 years of age will be enrolled within 28 days after treatment initiation. Guardians, children or both 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 12 weeks starting from the date of enrollment. Guardian or patient-reported outcomes will be obtained at baseline, and weeks 4, 8 and 12. These outcomes will include the Symptom Screening in Pediatrics Tool (SSPedi), Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue scale, Faces Pain Scale-Revised (FPS-R) 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 guardians and children for each proxy/SSPedi (8-18 years) and proxy/mini-SSPedi (4-7 years) and anticipate 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 our purposes.

View this trial on ClinicalTrials.gov