Three Times Weekly Symptom Screening for Children With Cancer
Condition: Cancer; Relapsed Cancer
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): SPARK
Intervention type(s): Other
Intervention description(s): Prompt to complete symptom screening three times weekly via SPARK with corresponding feedback sent to healthcare providers with each completed assessment.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care