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Pain Caregiver App for Pediatric Cancer
N/A
Waitlist Available
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to help children with cancer who experience pain outside of the hospital setting by developing a smartphone app called PainCaRe. The app will provide real-time treatment advice to young patients and their caregivers
Who is the study for?
This trial is for family caregivers of younger children with pediatric cancer. These caregivers are looking to manage their child's pain, especially when they're not in the hospital. Caregivers who can use a smartphone app and participate in its evaluation process may be eligible.
What is being tested?
The PainCaRe clinical trial is testing a new smartphone-based app designed to help caregivers manage their child's cancer-related pain at home. The study will develop the app with caregiver input, test its usability, assess how feasible it is for wider use, and measure initial effectiveness.
What are the potential side effects?
Since this intervention involves using a smartphone application rather than medication or medical procedures, traditional physical side effects are not expected. However, there might be emotional or psychological impacts from managing pain care through an app.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability
Feasibility - accrual
Feasibility - adherence
+1 moreSecondary study objectives
Child health-related quality of life - child report
Child health-related quality of life - parent report
Child pain intensity - child report
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 Intervention
Participants will download the PainCaRe app from the web to their personal phone either virtually or in-person. Parents will receive app-based notifications to complete a pain assessment report once-daily. Assessments not completed will be marked as "missed". Parents will also have the ability to complete ad hoc pain assessments as needed.
In response to the assessment indicating a child has pain, evidence-based, algorithm-driven pharmacological, physical, or psychological pain treatment guidance will be provided. This guidance is tailored to the age and developmental stage of the child.
Group II: Control ArmActive Control1 Intervention
Parents randomized to the control arm (non-intervention group) will not be assigned to the PainCaRe app and their child will continue to receive standard medical and pain care.
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Who is running the clinical trial?
The Hospital for Sick ChildrenLead Sponsor
710 Previous Clinical Trials
6,958,156 Total Patients Enrolled
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