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

40 Participants Needed

Trial Summary

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 data supports the effectiveness of the Pain Caregiver Resource (PainCaRe) treatment for managing pain in pediatric cancer patients?

Research shows that digital tools like apps can help manage pain in children with cancer by providing real-time support and reducing the emotional burden on caregivers. Similar apps have been effective in tracking pain and offering educational information, leading to less pain at home. ^{1 2 3 4 5}

Is the Pain Caregiver App for Pediatric Cancer safe for use in children?

Participants in a study found the app to be a useful, safe, and convenient way to help manage children's pain, providing real-time support and reducing the emotional burden of pain care. ^{1 3 4 6 7}

How is the Pain Caregiver App for Pediatric Cancer different from other treatments for managing pain in children with cancer?

The Pain Caregiver App for Pediatric Cancer is unique because it provides real-time, multimodal support for managing pain at home, which is often where pain management options are limited. Unlike traditional treatments, this app engages caregivers directly, offering comprehensive symptom tracking and evidence-based management advice, while also aiming to reduce the emotional burden on families. ^{1 3 4 6 8}

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pain monitoring app leads to less pain in children with cancer at home: Results of a randomized controlled trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Electronic Assessment and Tracking of Pain at Home: A Prospective Study in Children With Hematologic or Solid Tumors. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Parent and clinician perceptions and recommendations on a pediatric cancer pain management app: A qualitative co-design study. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

Development and testing of a multidimensional iPhone pain assessment application for adolescents with cancer. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Improving Children's cancer pain management in the home setting: Development and formative evaluation of a web-based program for parents. [2019]

6. United States 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Pediatric-Collaborative Health Outcomes Information Registry (Peds-CHOIR): a learning health system to guide pediatric pain research and treatment. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

A smartphone-based pain management app for adolescents with cancer: establishing system requirements and a pain care algorithm based on literature review, interviews, and consensus. [2021]