Pain Caregiver Resource (PainCaRe)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pediatric Cancer
• Intervention / Treatment: Other: Pain Caregiver Resource (PainCaRe)

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Principal Investigator; Phone Number: 206934 416-813-7654; Email: lindsay.jibb@sickkids.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G1X8
      • The Hospital for Sick Children
      • Contact: The Hospital for Sick Children Research Ethics Board; Phone Number: 205718 416-813-7654; Email: ask.crs@sickkids.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

1. Be the primary caregiver, or person assuming the majority of care activities, for a child aged 2-11 years undergoing cancer treatment and experiencing above mild pain (≥3/10) in the week preceding study enrolment (pain measured by self or caregiver proxy using a validated numerical 11-point rating scale).
2. Be able to speak and read English.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; 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.	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.
No Intervention: Control Arm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility - attrition	Percent of caregivers not completing 8-week outcome measures. Criteria for feasibility: attrition <25%.	1 year
Feasibility - accrual	Percent of eligible caregivers accrued per recruitment day. Criteria for feasibility: accrual >60%.	1 year
Feasibility - adherence	Adherence to the intervention will be measured using the Analytics Platform to Evaluate Effective Engagement (APEEE) platform, a proprietary analytics software measuring the number of once-daily pain assessments completed and engagement with pain treatment guidance. Criteria for feasibility: adherence to twice-daily pain reporting >65%.	8 weeks
Acceptability	Measured with the Acceptability E-Scale (AES). Criteria for acceptability: mean score of 4 on each item	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child pain intensity - parent report	Measured by caregiver proxy report using the Brief Pain Inventory	8 weeks
Child pain intensity - child report	Measured by self-report for children ≥4 years of age using the Faces Pain Scale-Revised .	8 weeks
Child pain interference - parent report	Measured by parent proxy for children <8 years of age using appropriate version of PROMIS Pediatric Scale	8 weeks
Child pain interference - child report	Measured by self-report for children ≥8 years of age using appropriate version of PROMIS Pediatric Scale .	8 weeks
Child health-related quality of life - parent report	Measured by self-report for children <8 years of age using appropriate versions of the Pediatric Quality of Life Inventory 4.0 .	8 weeks
Child health-related quality of life - child report	Measured by self-report for children <8 years of age using appropriate versions of the Pediatric Quality of Life Inventory 4.0 .	8 weeks
Parent quality of life	Measured by parent report using the Caregiver Quality of Life Index - Cancer .	8 weeks
Parent pain management self-efficacy	Measured by parent report using the Pain Self-Efficacy Scale .	8 weeks
Parent care satisfaction	Measured by parent report using the Satisfaction with Child Healthcare Survey .	8 weeks

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: October 16, 2024
• First Submitted That Met QC Criteria: October 18, 2024
• First Posted (Actual): October 21, 2024

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 1000081481

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will only be only be used as part of this study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No