Enabling Symptom Identification and Tracking in Children Receiving Cancer Treatment

The Hospital for Sick Children

Status: Completed

Conditions: Quality of Life; Symptom Screening; Pediatric Cancer

Treatments: Other: Standard of care; Other: Symptom feedback to Health Care Provider

Study type: Interventional

Funder types: Other

Identifiers

NCT03495518

REB #1000053137

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• We will include children with cancer and HSCT recipients who are 8-18 years of age at enrollment and who can understand English.
• Participants may be inpatients or outpatients, and may be actively receiving cancer treatment or may have completed treatment.

Exclusion criteria

• Exclusion criteria will be illness severity, cognitive disability, or visual impairment that precludes utilization of SPARK according to the healthcare team.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Symptom feedback to Health Care Provider

Active Comparator group

Description:

For those randomized to the intervention arm, symptom screening using SPARK will be completed once daily for 5 days on an iPad using the approach refined in aim 2. Daily SSPedi reports will be printed and provided in the patient chart. On days 1 and 3±1, a report describing symptoms that are "a lot" or "extremely" bothersome will be emailed to the physician providing direct medical care

Treatment:

Other: Symptom feedback to Health Care Provider

Standard of care

Active Comparator group

Description:

For those randomized to the control arm, 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.

Treatment:

Other: Standard of care