Pain Caregiver Resource (PainCaRe)

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (1)

More The Hospital for Sick Children trials in Canada

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