Pain Caregiver App for Pediatric Cancer

Recruiting in Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: The Hospital for Sick Children

No Placebo Group

Trial Summary

What is the purpose of this 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.

Eligibility Criteria

This trial is for family caregivers of younger children with pediatric cancer. These caregivers are looking to manage their child's pain, especially when they're not in the hospital. Caregivers who can use a smartphone app and participate in its evaluation process may be eligible.

Inclusion Criteria

I am the main caregiver for a child aged 2-11 in cancer treatment with pain level ≥3.

Be able to speak and read English

Participant Groups

The PainCaRe clinical trial is testing a new smartphone-based app designed to help caregivers manage their child's cancer-related pain at home. The study will develop the app with caregiver input, test its usability, assess how feasible it is for wider use, and measure initial effectiveness.

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention ArmExperimental Treatment1 Intervention

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.

Group II: Control ArmActive Control1 Intervention

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.