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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app called Pain Buddy, designed to track pain and symptoms in children undergoing chemotherapy for cancer. The app aims to enhance children's quality of life by enabling doctors and families to manage pain more effectively at home. Children may qualify for this trial if they are between 8 and 18 years old, currently receiving outpatient cancer treatment, and have internet access at home. Participants will either use the app to report daily pain and symptoms or learn coping skills through the app. The goal is to determine if Pain Buddy can significantly improve pain management and quality of life for young cancer patients. As an unphased trial, this study provides families with a unique opportunity to contribute to innovative research that could advance pain management for children with cancer.

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 prior data suggests that the Pain Buddy app is safe for children with cancer?

Research shows that Pain Buddy, a digital app for tracking pain, is popular with children who have cancer. Studies have found that kids willingly use the app to share their feelings. The app also provides helpful information and advice from healthcare professionals, aiding in better pain management.

In an initial study, Pain Buddy reduced pain levels for children receiving cancer treatment. This indicates the app is not only safe but also effective in managing symptoms. No major side effects were reported in these studies, demonstrating that Pain Buddy is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Pain Buddy app because it offers a unique approach to managing pain in children with cancer. Unlike standard treatments that often rely solely on medications and regular medical visits, Pain Buddy integrates technology to actively engage children in their own pain management. This app not only allows kids to keep daily pain diaries but also teaches them cognitive and behavioral coping skills, such as deep breathing and relaxation, through a tablet. Additionally, the app provides real-time data to healthcare providers, enabling timely interventions if pain thresholds are exceeded. This combination of self-management and remote monitoring makes Pain Buddy a promising tool for improving pain control in young patients.

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

Studies have shown that the Pain Buddy app can effectively help manage pain in children receiving cancer treatment. A small initial study found that it reduced the severity of pain during these treatments. Research also shows that using Pain Buddy at home leads to fewer serious pain episodes. This trial will evaluate the Pain Buddy app, which offers daily check-ins and teaches skills like deep breathing and relaxation to better manage pain. Participants in the experimental arm will receive skills training and remote monitoring, while those in the control arm will not receive these additional interventions. This tool seems promising for helping children handle pain and symptoms related to cancer. ^{2 3 4 6 7}

Who Is on the Research Team?

Michelle A Fortier, Ph.D.

Principal Investigator

University of California, Irvine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32743950/

A pilot study of the preliminary efficacy of Pain Buddy - PubMed The findings from this pilot study suggest that Pain Buddy may aid in the reduction of pain severity in children during cancer treatment.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5639256/

Pain buddy: A novel use of m-health in the management of ... Pain Buddy appears to be a promising tool to improve pain and symptom management in children undergoing cancer treatment.

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 ... These results show that the patients who used the pain monitoring app in the home setting had less clinically significant pain incidences, less ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0010482516301871

Pain buddy: A novel use of m-health in the management ... Pain Buddy appears to be a promising tool to improve pain and symptom management in children undergoing cancer treatment. Results from the ...

5. trialx.com trialx.com/clinical-trials/listings/281642/treating-pain-in-children-with-cancer-pain-buddy/?&radius=50&query=Childhood%20Cancer&smt=true

Treating Pain in Children With Cancer: Pain Buddy The purpose of this study is to examine the feasibility of the ambulatory monitoring protocol, called Pain Buddy, in documenting children's pain ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9944681/

Digital health tools for pain monitoring in pediatric oncology We aimed to systematically identify and characterize existing digital health tools for pain monitoring in children with cancer, and to assess common barriers ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1462388921000557

Communication of pain by school-age children with cancer ... These results demonstrate that school-age children with cancer are willing to describe their ambulatory pain experiences on a game-based mobile app.