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Enabling Symptom Identification and Tracking in Children Receiving Cancer Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495518
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : December 4, 2019
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Lillian Sung, The Hospital for Sick Children

Tracking Information
First Submitted Date  ICMJE February 20, 2018
First Posted Date  ICMJE April 12, 2018
Last Update Posted Date December 4, 2019
Actual Study Start Date  ICMJE July 2, 2018
Actual Primary Completion Date November 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
Feasibility of an RCT of symptom feedback to healthcare providers versus standard of care [ Time Frame: 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 ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
  • Pediatric Quality of Life (Peds QL) Cancer Module Acute Version [ Time Frame: Measure will be completed by participant on day 5±1 day. ]
    Measures self-reported symptoms related to cancer treatment, capturing physical, psychological and cognitive health. 5-point likert scale ranging from 0(almost never) to 4 (almost always); there is no weighting of items. Scores are transformed on a scale from 0 to 100. Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Mean score is calculated= Sum of the items over the number of items answered. Total Score is used and calculated by: Sum of all the items over the number of items answered on all the Scales. Higher scores indicate lower problems.
  • Symptom Screening in Pediatrics (SSPedi) [ Time Frame: 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. ]
    Self-reported symptom screening questionnaire asking pediatric patients (age 8-18) how bothered they are by 15 identified symptoms and side effects of cancer treatment. This 5-point Likert scale score from 0 (not bothered at all) to 4 (extremely bothered), and has a total score ranging from 0-60, with a higher number indicating more bother cancer-related symptoms. Likert scores will be summed for a total score that ranges from 0 (none) to 60 (worst possible).
  • Faces Pain Scale Revised [ Time Frame: Measure will be completed on day 5±1 day. ]
    The Faces Pain Scale Revised is a self-report measure of pain intensity developed for children to score the sensation of pain on the 0-to-10 metric. The scale shows a close linear relationship with visual analog pain scale, counting left to right; 0" = "no pain" and "10" = "very much pain
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enabling Symptom Identification and Tracking in Children Receiving Cancer Treatment
Official Title  ICMJE Refinement and Early Evaluation of SPARK, an Approach to Enable Symptom Screening and Monitoring by Children Receiving Cancer Treatments
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Pediatric Cancer
  • Quality of Life
  • Symptom Screening
Intervention  ICMJE
  • Other: 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
  • 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.
Study Arms  ICMJE
  • Active Comparator: 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
    Intervention: Other: Symptom feedback to Health Care Provider
  • Active Comparator: 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.
    Intervention: Other: Standard of care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 4, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2020
Actual Primary Completion Date November 16, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lillian Sung 416-813-5287 lillian.sung@sickkids.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03495518
Other Study ID Numbers  ICMJE REB #1000053137
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lillian Sung, The Hospital for Sick Children
Study Sponsor  ICMJE The Hospital for Sick Children
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Lillian Sung, MD The Hospital for Sick Children
PRS Account The Hospital for Sick Children
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP