Enabling Symptom Identification and Tracking in Children Receiving Cancer Treatment

NCT03495518 | Completed

• 1 other identifier: REB #1000053137
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Pediatric Cancer; Quality of Life; Symptom Screening

Keywords

Cancer; Randomized Control Trial; Children; Hematopoietic stem cell transplantation; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Feasibility of an RCT of symptom feedback to healthcare providers versus standard of care

  Will be determined by both the number of patients who are recruited for this study, and the number of patients who complete at least 60% of evaluations. We will aim to enroll 30 participants at SickKids over one year. Outcome feasibility will be met if at least 30 participants are enrolled within one year and at least 75% complete at least 60% of evaluations

  Study will be enrolling for 1 year with a goal to enroll 30 participants. Feasibility will be determined once all 30 participants have completed the study after 1 year

Secondary Outcomes (3)

• Pediatric Quality of Life (Peds QL) Cancer Module Acute Version

  Measure will be completed by participant on day 5±1 day.

• Symptom Screening in Pediatrics (SSPedi)

  Those randomized to the intervention arm measure will be completed by participant every day for 5 days. Those randomized to control arm measure will be completed by participant on Days 1 and 5±1 day.

• Faces Pain Scale Revised

  Measure will be completed on day 5±1 day.

Study Arms (2)

Symptom feedback to Health Care Provider

ACTIVE COMPARATOR

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

Other: Symptom feedback to Health Care Provider

Standard of care

ACTIVE COMPARATOR

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.

Other: Standard of care

Interventions

Symptom feedback to Health Care Provider 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

Symptom feedback to Health Care Provider

Standard of care 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.

Standard of care

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

The Hospital For SickKids

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Lillian Sung, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Oncologist

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: April 12, 2018
• Study Start: July 2, 2018
• Primary Completion: November 16, 2018
• Study Completion: December 31, 2019
• Last Updated: February 4, 2021

Record last verified: 2021-02

Locations

CA (1)