Pain Caregiver App for Pediatric Cancer

Overseen By Principal Investigator

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Disqualifiers: Non-English speakers, Non-caregivers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app called PainCaRe, designed to help parents manage pain in children with cancer, especially at home. The app provides real-time advice on treating pain using medications, physical methods, or psychological strategies, tailored to the child's age. Parents receive reminders to assess their child's pain daily and can use the app whenever needed. The trial seeks primary caregivers of children aged 2-11 undergoing cancer treatment who have recently experienced moderate pain. Participants must be able to speak and read English. As an unphased trial, this study offers caregivers a unique opportunity to contribute to innovative pain management solutions for children with cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Pain Caregiver Resource (PainCaRe) app is safe for use in pediatric cancer care?

Research has shown that the Pain Caregiver Resource (PainCaRe) app is safe and helpful for managing children's pain. Participants in a study found the app easy to use for immediate support. No reports of harmful effects have emerged from using the app. It offers educational information and feedback from healthcare professionals, which helps reduce pain in children with cancer. Caregivers generally appreciate the app, making it a promising choice for managing pain in young patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Pain Caregiver Resource (PainCaRe) app because it offers a personalized, tech-driven approach to managing pain for children with cancer, something traditional treatments don't provide. Unlike standard pain management, which often involves medication and general strategies, this app tailors recommendations based on real-time pain assessments, considering the child's age and development. By integrating evidence-based pharmacological, physical, and psychological guidance into a smartphone app, PainCaRe empowers parents to address their child's pain promptly and effectively, potentially improving quality of life and care.

What evidence suggests that the PainCaRe app is effective for managing pain in children with cancer?

Research has shown that smartphone apps can help manage pain in children with cancer. In this trial, participants in the intervention arm will use the PainCaRe app, designed to help parents monitor and manage their child's pain with proven advice. It is based on a pain assessment method effective for children with cancer. Another app, Pain Buddy, was tested in a study and helped reduce cancer-related pain in children. These findings suggest that using a mobile app like PainCaRe could enhance parents' ability to manage their child's pain by providing timely advice and boosting their confidence in handling pain. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the PainCaRe app for pain management, receiving app-based notifications for daily pain assessments and treatment guidance

8 weeks

Daily virtual interactions via app

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pain Caregiver Resource (PainCaRe)

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 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 Arm Active Control 1 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.

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Published Research Related to This Trial

The Peds-CHOIR system, designed for pediatric chronic pain management, allows for real-time data collection from patients (aged 8-17) and their caregivers, enhancing both clinical decision-making and research capabilities.

Initial findings from 352 patients showed significant impairments in physical, psychological, and social domains, with caregivers reporting greater internal experience impairments than patients, highlighting the importance of capturing both perspectives for tailored treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric-Collaborative Health Outcomes Information Registry (Peds-CHOIR): a learning health system to guide pediatric pain research and treatment. Bhandari, RP., Feinstein, AB., Huestis, SE., et al.[2022]

In a 60-day randomized controlled trial with 48 children, the Pain Buddy mHealth application showed promise in managing cancer-related pain, leading to a significant reduction in instances of moderate to severe pain in the intervention group compared to the control group.

While both groups experienced a decrease in average daily pain, the intervention group reported no instances of moderate to severe pain by the end of the study, suggesting that Pain Buddy may effectively enhance pain management during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of the preliminary efficacy of Pain Buddy: A novel intervention for the management of children's cancer-related pain. Hunter, JF., Acevedo, AM., Gago-Masague, S., et al.[2023]

The Pain Squad app, designed for adolescents with cancer, effectively collects detailed pain data and has shown high compliance rates of 81% during a 2-week feasibility trial, indicating its usability and acceptance among users.

The app's game-based design and reward system were particularly appealing to adolescents, contributing to their satisfaction and consistent use, which is crucial for better pain management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and testing of a multidimensional iPhone pain assessment application for adolescents with cancer. Stinson, JN., Jibb, LA., Nguyen, C., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11514300/

Co‐design and usability testing of the PainCaRe app - PMC The nine‐item pain assessment questionnaire is based on a valid and reliable pediatric cancer pain measure developed by our team and queries ...

2. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/550795

Pain Caregiver Resource (PainCaRe) Outcome measure. Parent pain management self-efficacy. Measure description. Measured by parent report using the Pain Self-Efficacy Scale . Time frame. 8 weeks.

3. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.35100

Pain monitoring app leads to less pain in children with cancer ... The authors developed a pain monitoring app offering educational information, and real-time health care professional feedback on clinically significant pain.

4. withpower.com withpower.com/trial/phase-pediatrics-cancer-11-2024-15a6a

Pain Caregiver App for Pediatric Cancer · Info for Participants In a 60-day randomized controlled trial with 48 children, the Pain Buddy mHealth application showed promise in managing cancer-related pain, leading to a ...

5. cancer.jmir.org cancer.jmir.org/2018/2/e10280/

A Pilot Implementation Study - JMIR Cancer Background: Pain Squad is an evidence-based, freely available iOS app designed to assess pain in children with cancer.

6. journals.plos.org journals.plos.org/digitalhealth/article?id=10.1371/journal.pdig.0000169

A qualitative co-design study | PLOS Digital Health Participants endorsed the concept of an app as a useful, safe, and convenient way to engage caregivers in managing their young child's pain.