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

33 Participants Needed

Trial Summary

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 data supports the effectiveness of the ATOMIC Mobile App treatment for pediatric cancer survivors?

Research shows that digital health interventions, like mobile apps, are feasible and acceptable for childhood cancer survivors, helping them manage their health after treatment. While specific data on the ATOMIC Mobile App is not available, similar apps have been used to support medication adherence and symptom management in oncology patients. ^{1 2 3 4 5}

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 ATOMIC Mobile App. However, digital health interventions in general have been found to be feasible and acceptable for pediatric cancer survivors. ^{3 6 7 8 9}

How is the ATOMIC Mobile App treatment different from other treatments for pediatric cancer survivors?

The ATOMIC Mobile App is unique because it focuses on providing support and resources through a digital platform specifically designed for pediatric cancer survivors, which is different from traditional treatments like radiotherapy or chemotherapy that directly target cancer cells. This app may offer tools for managing long-term health and quality of life, which are not typically addressed by standard cancer treatments. ^{10 11 12 13 14}

What is the purpose of this trial?

Development and Usability Testing of the ATOMIC Mobile App to Increase Physical Activity (PA) Levels in Children, Adolescent and Young Adults (AYA) survivors of childhood cancer

Research Team

Olga H Toro-Salazar, MD

Principal Investigator

CT Children's Medical Center

Eligibility Criteria

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 a child cancer survivor not scheduled for anthracycline therapy.

I am unable to participate in interviews.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Feasibility of Weekly Electronic Patient- and Proxy-Reported Outcome Measures in Pediatric Oncology. [2023]

2. England 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. [2021]

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

The Pediatric Cancer Survivors' User Experiences With Digital Health Interventions: A Systematic Review of Qualitative Data. [2022]

4. United States 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. [2022]

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

Evaluation of mobile phone applications to support medication adherence and symptom management in oncology patients. [2019]

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

A global approach to long-term follow-up of targeted and immune-based therapy in childhood and adolescence. [2022]

7. United States 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. [2021]

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

Development of a Pediatric Adverse Events Terminology. [2019]

9. Brazil pubmed.ncbi.nlm.nih.gov

Adolescents' understanding of chemotherapy-related adverse events: a concept elicitation study. [2022]

10. England pubmed.ncbi.nlm.nih.gov

QUARTET: A SIOP Europe project for quality and excellence in radiotherapy and imaging for children and adolescents with cancer. [2022]

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

The role of proton therapy in pediatric malignancies: Recent advances and future directions. [2020]

12. Germany pubmed.ncbi.nlm.nih.gov

A dedicated cloud system for real-time upfront quality assurance in pediatric radiation therapy. [2020]

13. England 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. [2019]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical research tools in pediatric oncology: challenges and opportunities. [2020]