Pain Caregiver Resource (PainCaRe)

Not Applicable

Not yet recruiting

• Conditions: Pediatric Cancer

• Registration Number: NCT06651190
• Lead Sponsor: The Hospital for Sick Children

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-16
• Study First Submitted QC: 2024-10-18
• Study First Posted: 2024-10-21
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-11
• Study Start: 2024-12
• Primary Completion: 2025-09
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility - attrition	1 year	Percent of caregivers not completing 8-week outcome measures. Criteria for feasibility: attrition \<25%.
Feasibility - accrual	1 year	Percent of eligible caregivers accrued per recruitment day. Criteria for feasibility: accrual \>60%.
Feasibility - adherence	8 weeks	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%.
Acceptability	8 weeks	Measured with the Acceptability E-Scale (AES). Criteria for acceptability: mean score of 4 on each item

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada