Pain Buddy App for Childhood Cancer

Overseen By Lessley B Torres, BA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Cognitive impairment, AML, APL, others

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

Compensation: Varies

Number of Visits: Unknown

206 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to examine the feasibility of the ambulatory monitoring protocol, called Pain Buddy, in documenting children's pain, symptoms and quality of life while receiving outpatient chemotherapy. The long term goal of Pain Buddy is to help doctors, nurses, and parents get the information they need to give children treatments for pain and symptom management that work. Using Pain Buddy, we aim to quantify the prevalence and intensity of daily pain and symptom episodes in children at home, data that will be used to develop a psychosocial intervention to be delivered electronically to children at home with a goal of improving quality of life. Secondary aims also include examining children's quality of life pre- and post- Pain Buddy and satisfaction with the use of Pain Buddy. This project has the potential to improve the quality of life of tens of thousands of children suffering from cancer each year using transformative mobile health information technology based approach to pain assessment and management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on monitoring pain and symptoms using the Pain Buddy app while you continue your outpatient cancer treatment.

What data supports the effectiveness of the Pain Buddy treatment for managing pain in children with cancer?

The Pain Buddy app is a mobile health tool designed to help manage cancer-related pain in children. Preliminary studies suggest it may reduce pain severity and frequency by providing a structured way for children to report and manage their pain, similar to the Pain Squad app, which has shown reliability and effectiveness in tracking pain in adolescents with cancer. ^{1 2 3 4 5}

Is the Pain Buddy app safe for children with cancer?

The available research does not specifically mention safety concerns for the Pain Buddy app, but it is designed to help manage pain in children with cancer, suggesting it is considered safe for use in this context. ^{1 3 4 5 6}

How is the Pain Buddy app treatment different from other treatments for managing cancer-related pain in children?

The Pain Buddy app is unique because it is a mobile health application specifically designed to manage cancer-related pain in children by providing a multicomponent approach. Unlike traditional pain management methods, it offers real-time support and monitoring, which can help address the gap in effectively managing pain in this young population. ^{1 3 4 6 7}

Research Team

Michelle A Fortier, Ph.D.

Principal Investigator

University of California, Irvine

Eligibility Criteria

This trial is for children aged 8-18 with cancer, undergoing outpatient treatment. They must be able to speak, read, and write in English (or their parents in English/Spanish), have home internet access for Pain Buddy use. Children with AML or APL or cognitive impairments are excluded.

Inclusion Criteria

I am between 8 and 18 years old.

I can speak, read, and write in English or Spanish.

I am receiving cancer treatment without staying in the hospital.

Exclusion Criteria

My child does not have cognitive impairments that would prevent them from using a digital pain tracking program.

My child does not have AML or APL leukemia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I: Development and Formative Evaluation

Development and evaluation of the Pain Buddy program for usability and acceptability

Not specified

Phase II: Randomized Controlled Trial

Evaluation of the efficacy of Pain Buddy in managing pain and symptoms in children with cancer

Approximately 60 days

Phase III: Multi-Site Randomized Controlled Trial

Determine the effectiveness of Pain Buddy in reducing pain severity among children undergoing outpatient cancer treatment

Approximately 180 days

Follow-up

Participants are monitored for changes in quality of life, anxiety, depression, and stress

180 days

Treatment Details

Interventions

• Pain Buddy

Trial Overview Pain Buddy is being tested to see if it can help monitor pain and improve quality of life for children receiving chemotherapy at home. It's a mobile health tech tool that tracks daily pain and symptoms to aid in managing treatments effectively.

Participant Groups

Group I: Pain Buddy Experimental Treatment 1 Intervention

Children in this condition will continue with the care that has been prescribed for cancer- and chemotherapy-related pain and symptoms, which may include medications, medical visits, physical interventions, etc. Participants in this condition will complete daily diaries using Pain Buddy and will also be taught cognitive and behavioral coping skills, like deep breathing, imagery, and relaxation, to deal with pain and symptoms. The skills will be taught through the electronic tablet. Pain and symptom information, collected daily by Pain Buddy, will be sent to a health care provider on the oncology treatment team, who will contact patients when certain thresholds are reached and will instruct the patients on best ways to control pain and symptoms.

Group II: Control Active Control 1 Intervention

Children in this condition will continue with the care that has been prescribed for cancer- and chemotherapy-related pain and symptoms, which may include medications, medical visits, physical interventions, etc. Participants in this condition will complete daily pain diaries using Pain Buddy, but will not receive skills training or remote monitoring of data.

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

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]

Nineteen school-age children with cancer successfully used a game-based symptom assessment app to report their pain experiences over five days, indicating that children are willing to engage with technology for pain tracking.

The majority of reported pain was mild in severity and bother, with common locations being the head and stomach, suggesting that this app could help clinicians better understand and manage pain in pediatric cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communication of pain by school-age children with cancer using a game-based symptom assessment app: A secondary analysis. Bernier Carney, KM., Jung, SH., Iacob, E., 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+ smartphone app was implemented with 40 adolescents with cancer over 28 days, showing trends toward significant improvements in pain intensity, pain interference, and health-related quality of life, with effect sizes ranging from 0.23 to 0.67.

The study demonstrated that the app is feasible for use, although some technical difficulties were encountered, and it was generally well-accepted by participants, indicating potential for further evaluation in a larger randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and preliminary effectiveness of a real-time pain management smartphone app for adolescents with cancer: A multicenter pilot clinical study. Jibb, LA., Stevens, BJ., Nathan, PC., et al.[2017]

References

1. Canada pubmed.ncbi.nlm.nih.gov

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

2. Scotland pubmed.ncbi.nlm.nih.gov

Communication of pain by school-age children with cancer using a game-based symptom assessment app: A secondary analysis. [2022]

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

Construct validity and reliability of a real-time multidimensional smartphone app to assess pain in children and adolescents with cancer. [2022]

4. 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]

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

Pain buddy: A novel use of m-health in the management of children's cancer pain. [2022]

6. 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]

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

Implementation and preliminary effectiveness of a real-time pain management smartphone app for adolescents with cancer: A multicenter pilot clinical study. [2017]