Enabling Symptom Identification and Tracking in Children Receiving Cancer Treatment
Condition: Pediatric Cancer; Quality of Life; Symptom Screening
Study type: Interventional

Summary: 
      Children with cancer and hematopoietic stem cell transplant (HSCT) recipients suffer from
      severe and bothersome symptoms because treatments are intense. So, the investigators
      developed SPARK (Supportive care Prioritization, Assessment and Recommendations for Kids), a
      website devoted to helping children track symptoms and providing a way to let doctors and
      nurses know which symptoms are bothersome. This study will examine the likelihood that
      children will complete SPARK once daily, help the investigators figure out how to improve the
      website so that children will use it, and help the investigators plan the large scale trial
      to test its efficacy in improving quality of life (QoL).

      Participants will be children with cancer or HSCT recipients who are 8-18 years of age and
      who are expected to be in hospital or in clinic daily for 5 days.To determine the feasibility
      of a randomized controlled trial (RCT) of symptom feedback to healthcare providers
    

Detailed description: 
      Methods: Participants will be children with cancer or HSCT recipients who are 8-18 years of
      age and who can understand English, and who are expected to be in hospital or in clinic daily
      for 5 days.

      SPARK RCT will be a pilot multi-center RCT in which we will randomize children to either
      undergo daily symptom screening for 5 days with symptom reports provided to the healthcare
      team or standard of care. Feasibility will be met if at least 30 participants are enrolled
      within one year and at least 75% complete at least 60% of evaluations.

      Quality of the Idea Children receiving cancer treatment have excellent survival outcomes, in
      part, related to the provision of intensive therapies. Unfortunately, most children suffer
      and experience severe and bothersome treatment-related symptoms. Symptoms not only impact on
      QoL and morbidity but, in addition, may negatively influence future psychosocial functioning.

      Symptoms remain unaddressed even during healthcare encounters because children do not
      complain and clinicians fail to ask about them. We recently developed SSPedi, a
      pediatric-specific symptom screening tool on an iPad. SSPedi, however, consists only of the
      questions which ask about symptoms. SPARK is the web-based application which will facilitate
      access to SSPedi, encourage symptom screening, generate reports and allow children to track
      their symptoms. Careful thought to design is required to ensure SPARK optimizes future use
      and has clinical utility. The proposed project output is a product that facilitates
      longitudinal symptom screening and provides the groundwork for a future RCT of symptom
      feedback.
    

Intervention name(s): Symptom feedback to Health Care Provider; Standard of care
Intervention type(s): Other; Other
Intervention description(s): These children will complete SPARK daily for 5 days in a row, daily symptom reports will be printed and provided in the patient chart. On days 1 and 3, a report describing symptoms that are "a lot" or "extremely" bothersome will be emailed to the physician providing direct medical; A clinical research associate will visit the participant on days 1 and 5±1 and will obtain SSPedi scores on an iPad. Reports will not be printed or emailed to the physician.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cancer; Randomized Control Trial; Children; Hematopoietic stem cell transplantation; Quality of Life