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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Enrollment
40
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.
The Hospital for Sick Children
Toronto, Ontario, Canada
Feasibility - attrition
Percent of caregivers not completing 8-week outcome measures. Criteria for feasibility: attrition \<25%.
Time frame: 1 year
Feasibility - accrual
Percent of eligible caregivers accrued per recruitment day. Criteria for feasibility: accrual \>60%.
Time frame: 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%.
Time frame: 8 weeks
Acceptability
Measured with the Acceptability E-Scale (AES). Criteria for acceptability: mean score of 4 on each item
Time frame: 8 weeks
Child pain intensity - parent report
Measured by caregiver proxy report using the Brief Pain Inventory
Time frame: 8 weeks
Child pain intensity - child report
Measured by self-report for children ≥4 years of age using the Faces Pain Scale-Revised .
Time frame: 8 weeks
Child pain interference - parent report
Measured by parent proxy for children \<8 years of age using appropriate version of PROMIS Pediatric Scale
Time frame: 8 weeks
Child pain interference - child report
Measured by self-report for children ≥8 years of age using appropriate version of PROMIS Pediatric Scale .
Time frame: 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 .
Time frame: 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 .
Time frame: 8 weeks
Parent quality of life
Measured by parent report using the Caregiver Quality of Life Index - Cancer .
Time frame: 8 weeks
Parent pain management self-efficacy
Measured by parent report using the Pain Self-Efficacy Scale .
Time frame: 8 weeks
Parent care satisfaction
Measured by parent report using the Satisfaction with Child Healthcare Survey .
Time frame: 8 weeks
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