Enabling Symptom Identification and Tracking in Children Receiving Cancer Treatment

NCT ID: NCT03495518

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-02
• Study Completion Date: 2019-12-31

Brief 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.

Conditions

Pediatric Cancer; Quality of Life; Symptom Screening

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Symptom feedback to Health Care Provider

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

Group Type: ACTIVE_COMPARATOR

Symptom feedback to Health Care Provider

Intervention Type: OTHER

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

Standard of care

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.

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: OTHER

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.

Interventions

Symptom feedback to Health Care Provider

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

Intervention Type: OTHER

Standard of care

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Lillian Sung

Pediatric Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lillian Sung, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

The Hospital For SickKids

Toronto, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

REB #1000053137

Identifier Type: -

Identifier Source: org_study_id