Pediatric Cancer
Conditions
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.
Interventions
OTHERPain 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.
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 . |
| Child pain intensity - parent report | 8 weeks | Measured by caregiver proxy report using the Brief Pain Inventory |
| 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 . |
| Parent quality of life | 8 weeks | Measured by parent report using the Caregiver Quality of Life Index - Cancer . |
| 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 . |
Countries
Canada
Contacts
Primary ContactPrincipal Investigator
Outcome results
None listed