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NOT YET RECRUITING
NCT06651190
NA

Pain Caregiver Resource (PainCaRe)

Sponsor: The Hospital for Sick Children

View on ClinicalTrials.gov

Summary

Pain is a problem for children with cancer, especially when they are outside of the hospital setting. Younger children with cancer are particularly vulnerable to undermanaged pain because of their inability to self-report pain and their reliance on parents for treatment. One method to help these children to get the best care possible is through the use of smartphone-based mHealth solutions. Smartphone apps can provide treatment advice to patients experiencing pain in real-time and in any environment. This research will use a phased and user-centered approach with family caregivers to co-design and co-evaluate the new cancer Pain Caregiver Resource (PainCaRe) app to achieve the following aims: (1) high-fidelity software development and usability refinement; (2) evaluation of trial feasibility and preliminary effectiveness in a pilot randomized controlled trial (RCT); and (3) systematic analysis of caregiver app usage patterns to refine PainCaRe for optimal engagement prior to a future RCT.

Official title: Building mHealth Parent Capacity to Manage Pain in Young Children With Cancer: A Pilot Randomized Controlled Trial

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-04

Completion Date

2027-04

Last Updated

2025-12-15

Healthy Volunteers

No

Interventions

OTHER

Pain Caregiver Resource (PainCaRe)

The purpose of the PainCaRe mobile health app is to support parents of young children with cancer (between the ages of 2-11 years) to manage their cancer-related pain at home. The app will ask caregivers to completed a brief 6-question pain assessment once daily and complete ad hoc assessments as needed. Based on the results of the pain assessment, real-time, evidence-based pain management suggestions, including will be provided to parents. The purpose of the pilot randomized controlled trial (RCT) is to evaluate the feasibility of implementing PainCaRe in a future RCT. Please find attached the study protocol for reference.

Locations (1)

The Hospital for Sick Children

Toronto, Ontario, Canada