Atomic App for Pediatric Cancer Survivors

Overseen By Tiffany L Ruiz, BSN

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Connecticut Children's Medical Center

Must be taking: Anthracycline therapy

Disqualifiers: Non-English speaking, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new mobile app called ATOMIC, designed to boost physical activity in young survivors of childhood cancer. The app supports personalized exercise programs and allows participants to chat one-on-one with a physical activity coach to help them set and achieve fitness goals. The trial seeks children, teens, or young adults who have received anthracycline therapy and can speak English fluently. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance recovery and quality of life for young cancer survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the ATOMIC Mobile App is safe for pediatric cancer survivors?

Research has shown that mobile apps, such as the ATOMIC app, can assist children with cancer. However, specific safety information for the ATOMIC app itself is not available. Generally, mobile health apps are considered safe because they do not involve drugs or medical devices. They aim to improve health habits, such as increasing exercise.

The ATOMIC app encourages exercise in children who have survived cancer, primarily helping users remain active. As an app, it likely won't cause physical side effects like medication might. Nonetheless, it is important to use apps carefully and follow any advice from healthcare professionals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Atomic App for pediatric cancer survivors because it offers a personalized and supportive approach to exercise, tailored specifically for young survivors. Unlike traditional treatments that may not emphasize physical activity, this app leverages social-cognitive theory to motivate and guide users through a structured aerobic and resistance exercise regimen. The app's unique feature is its integration of one-on-one messaging with a personal physical activity coach, which helps users set and achieve their exercise goals, enhancing their overall recovery and well-being.

What evidence suggests that the ATOMIC Mobile App is effective for increasing physical activity in pediatric cancer survivors?

Research shows that mobile apps can help childhood cancer survivors become more active. Studies have found that technology-based tools, like apps, assist with managing symptoms, following treatment plans, and learning about health. An app called "Mila Blooms" promoted healthy eating and exercise among young cancer survivors. In this trial, researchers will test the ATOMIC app for its effectiveness in helping users reach their exercise goals with personal coaching. The ATOMIC app has shown promise in increasing activity levels. Overall, using a mobile app for fitness is a promising way to improve health in this group. ^{2 3 6 7 8}

Who Is on the Research Team?

Tiffany L Berthod (Ruiz), MSN

Principal Investigator

CT Children's Medical Center

Are You a Good Fit for This Trial?

This trial is for childhood cancer survivors aged 10 to 30 who can speak English fluently. They must have been treated with anthracycline therapy. It's not suitable for those unable to cooperate in interviews, non-English speakers, or anyone unable to understand interview content.

Inclusion Criteria

I am between 10 and 30 years old.

My child's cancer treatment includes anthracycline therapy.

Exclusion Criteria

Unable to understand the content of interviews

I am unable to participate in interviews.

I am a child cancer survivor not scheduled for anthracycline therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Usability Testing

Participants engage in 'real life' usability testing of the ATOMIC mobile app, performing individualized aerobic and resistance exercise interventions

4 weeks

4-5 sessions per week

Follow-up

Participants are monitored for ease of use and user errors during usability testing, and acceptability is assessed using the Acceptability E-Scale

1 year

What Are the Treatments Tested in This Trial?

Interventions

• ATOMIC

Trial Overview The ATOMIC mobile app is being tested for its ability to increase physical activity levels among children and young adults who survived pediatric cancer. The study involves development and usability testing of the app specifically designed for this group.

How Is the Trial Designed?

Group I: Real life usability testing Experimental Treatment 1 Intervention

B) "Real Life" Usability Testing. We will conduct a "real life" usability test in a sample of 6 pediatric cancer survivors. EX@HOME: Patients will perform an individualized aerobic and resistance exercise intervention, choosing from a list of PA, progressing from light to moderate-to-vigorous intensity totaling 30-45 min/d, 4-5 weekly/wk. for 4 weeks. The social-cognitive-theory-based mobile app will support the exercise intervention. One-on-one messaging chats with a PA coach through the mobile app will facilitate exercise goal establishment and attainment.

Who Is Running the Clinical Trial?

Connecticut Children's Medical Center

Lead Sponsor

Trials

76

Recruited

30,000+

The Hospital for Sick Children

Collaborator

Trials

724

Recruited

6,969,000+

Published Research Related to This Trial

There is a significant lack of knowledge regarding the long-term health impacts of novel targeted and immunotherapy agents used in children with cancer, despite advancements in understanding the toxicities of traditional treatments like surgery, radiation, and chemotherapy.

The ACCELERATE initiative aims to create an international registry to collect long-term follow-up data on these therapies, which will help ensure safety, support regulatory requirements, and guide treatment decisions for pediatric cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A global approach to long-term follow-up of targeted and immune-based therapy in childhood and adolescence. Kieran, MW., Caron, H., Winther, JF., et al.[2022]

The Pediatric Terminology Harmonization Initiative developed a comprehensive adverse event (AE) terminology specifically for pediatric care, containing over 1000 terms related to pediatric diseases and disorders, to improve international reporting and understanding of AEs.

This new terminology is designed for easy integration with existing biomedical vocabularies and is applicable in various healthcare settings, making it a valuable resource for enhancing pediatric clinical research and safety reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Pediatric Adverse Events Terminology. Gipson, DS., Kirkendall, ES., Gumbs-Petty, B., et al.[2019]

In a pilot study involving 26 female childhood cancer survivors, the Health Storylines mHealth app was used frequently, with some participants accessing it up to 902 times, but overall, there were no statistically significant improvements in self-efficacy, perceived illness, or health-related quality of life after 3 or 6 months of use.

The study highlighted that while the app's mental health component was utilized by all participants, the effectiveness varied significantly between high and low users, suggesting that further research is needed to identify which individuals benefit most from such mHealth interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use and Effect of the Health Storylines mHealth App on Female Childhood Cancer Survivors' Self-efficacy, Health-Related Quality of Life and Perceived Illness. Cantrell, MA., Ruble, K., Mensinger, J., et al.[2022]

The QUARTET Project aims to standardize and improve the quality of radiotherapy and imaging for children and adolescents with cancer across Europe, leveraging expertise from the European Society for Paediatric Oncology and the European Organisation for Research and Treatment of Cancer.

As of March 2022, QUARTET includes nine prospective clinical trials and two retrospective studies, creating a significant database to enhance the understanding and effectiveness of radiotherapy in treating various pediatric cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

QUARTET: A SIOP Europe project for quality and excellence in radiotherapy and imaging for children and adolescents with cancer. Kelly, SM., Effeney, R., Gaze, MN., et al.[2022]

Proton radiotherapy offers a safer treatment option for pediatric cancers by effectively sparing normal tissues, which helps reduce both acute and long-term side effects.

Over the past decade, more than 30 proton therapy facilities have opened in the U.S., allowing approximately 3,000 children annually to access this advanced treatment, with ongoing research to compare its efficacy and toxicity against traditional photon radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of proton therapy in pediatric malignancies: Recent advances and future directions. Greenberger, BA., Yock, TI.[2020]

Survival rates for childhood cancers have improved significantly, but outcomes for difficult-to-treat cancers have plateaued, highlighting the need for continued advancements in treatment.

There are ongoing international efforts to adapt clinical trial tools from adult oncology for pediatric use, which aim to enhance the evaluation of treatment toxicity, quality of life, and overall cancer care quality for children and adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical research tools in pediatric oncology: challenges and opportunities. de Rojas, T., Neven, A., Towbin, AJ., et al.[2020]

The European Society of Paediatric Oncology Ependymoma II program is focusing on improving treatment outcomes for childhood ependymomas by lowering the age for focal irradiation from three years to as young as one year, despite previous concerns about cognitive risks.

A new 'Core-Plus' model has been developed for longitudinal cognitive follow-up of childhood ependymoma survivors, which includes a standardized test battery to assess cognitive outcomes, ensuring that both essential and comprehensive evaluations can be conducted across different resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The European Society of Paediatric Oncology Ependymoma-II program Core-Plus model: Development and initial implementation of a cognitive test protocol for an international brain tumour trial. Thomas, S., Reynolds, D., Morrall, MCHJ., et al.[2019]

A study involving 187 pediatric clinicians identified 64 adverse event (AE) terms from the National Cancer Institute's CTCAE that are suitable for self-reporting by children aged 7 and older, enhancing the understanding of treatment toxicities in pediatric cancer.

The goal is to create a child-friendly self-report measure for AEs, which will improve the accuracy and completeness of toxicity reporting in clinical trials, ultimately leading to better care for children undergoing cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The first step to integrating the child's voice in adverse event reporting in oncology trials: a content validation study among pediatric oncology clinicians. Reeve, BB., Withycombe, JS., Baker, JN., et al.[2021]

A systematic review of eight studies on digital self-management interventions for childhood cancer survivors found that these interventions did not significantly improve health-related quality of life or moderate-to-vigorous physical activity, indicating limited effectiveness.

While the interventions showed a trend towards increasing physical activity over time, the results were not statistically significant, highlighting the need for better-designed studies to assess their true impact on health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of digital self-management interventions on health outcomes among childhood cancer survivors: A systematic review and meta-analysis. Hong, HC., Min, A., Kim, YM.[2021]

A centralized radiotherapy quality assurance (QA) program was successfully implemented in Italy for the SIOP PNET5 trial, ensuring that all participating centers adhered to treatment protocols for pediatric medulloblastoma patients.

Out of 24 enrolled patients, 62.5% required plan revisions before treatment, demonstrating the effectiveness of the QA system in optimizing radiotherapy plans and ensuring compliance, with no patients excluded due to dosimetric issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A dedicated cloud system for real-time upfront quality assurance in pediatric radiation therapy. Meroni, S., Cavatorta, C., Barra, S., et al.[2020]

A study involving 17 Brazilian adolescents aged 13-18 undergoing chemotherapy showed that they can effectively describe and report their chemotherapy-related adverse events, highlighting the importance of their perspectives in treatment assessments.

The research indicates that using open-ended questions during interviews can facilitate better communication and understanding of adverse events among adolescent cancer patients, paving the way for improved assessment tools tailored to their needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adolescents' understanding of chemotherapy-related adverse events: a concept elicitation study. Silva-Rodrigues, FM., Hinds, PS., Nascimento, LC.[2022]

Digital health interventions are generally well-received by pediatric cancer survivors, providing benefits such as self-awareness, social connection, and empowerment, based on a systematic review of 16 qualitative studies.

However, users also face challenges related to program content, technology, and personal usage, highlighting the need for tailored interventions to enhance their effectiveness and user satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pediatric Cancer Survivors' User Experiences With Digital Health Interventions: A Systematic Review of Qualitative Data. Cheng, L., Liu, F., Mao, X., et al.[2022]

The study demonstrated that collecting weekly electronic patient-reported outcome measures (ePROMs) from 70 pediatric cancer patients and their caregivers is feasible, with 69% completing the assessments over 8 weeks.

While distress and cancer-related quality of life improved over time, nearly half of the participants still reported high distress levels by the end of the study, indicating a need for ongoing assessment and timely interventions to address persistent symptoms and improve overall patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Weekly Electronic Patient- and Proxy-Reported Outcome Measures in Pediatric Oncology. Skrabal Ross, X., Condon, P., Yates, P., et al.[2023]

A scoping review identified 28 mobile apps designed for medication and symptom management in pediatric oncology patients, highlighting the potential for technology to support these patients.

The quality assessment of these apps revealed mean scores between 2.8 and 4.3, with most apps scoring low in user engagement, indicating a need for better design and functionality to enhance their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of mobile phone applications to support medication adherence and symptom management in oncology patients. Jupp, JCY., Sultani, H., Cooper, CA., et al.[2019]

Citations

1. ctv.veeva.com ctv.veeva.com/study/atomic-mobile-app-to-increase-physical-activity-pa-levels-in-survivors-of-childhood-cancer

ATOMIC Mobile App to Increase Physical Activity (PA) Levels ... The purpose of this program of research is to (1) determine the adaptations required of a pre-existing mobile fitness app to tailor it for childhood cancer ...

2. cinj.org cinj.org/exploring-mobile-app-promote-physical-activity-childhood-cancer-survivors

Exploring a Mobile App to Promote Physical Activity for ... This new research will focus on the development of a mobile app designed to promote physical activity and fitness for adolescent and young adult survivors, ...

3. gavinpublishers.com gavinpublishers.com/article/view/a-mobile-application-for-childhood-cancer-survivorship-care:-a-cross-sectional-survey-study

A Mobile Application for Childhood Cancer Survivorship Care Technology-based interventions have already been used successfully in adult and childhood cancer survivorship care. Web-based or application-based interventions ...

4. mdpi.com mdpi.com/2227-9067/12/7/927

A Systematic Review and Meta-Analysis In summary, mobile applications aimed at children with cancer have proven to be viable tools for symptom control, therapeutic adherence, health education, and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7457971/

Mila Blooms: A Mobile Phone Application and Behavioral ... We developed an app-based game (“Mila Blooms”) that promotes healthy eating and physical activity among adolescent survivors of childhood cancer.

6. withpower.com withpower.com/trial/phase-pediatrics-cancer-3-2023-80b0e

Atomic App for Pediatric Cancer Survivors · Info for Participants Is the Atomic App for Pediatric Cancer Survivors safe for use? There is no specific safety data available for the Atomic App or its other names like ATOMIC or ...

7. mhealth.jmir.org mhealth.jmir.org/2020/7/e17134/

Assessment of the Fairness of Privacy Policies of Mobile ... In this paper, we introduce a novel scale based on the General Data Protection Regulation (GDPR) to assess the fairness of mHealth app privacy ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11460307/

mHealth Apps in the Digital Marketplace for Pediatric ... This study reports a systematic search and analysis of mHealth apps available on the Apple App (iOS) and Google Play (Android) stores designed for pediatric ...