Atomic App for Pediatric Cancer Survivors
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Connecticut Children's Medical Center
Must be taking: Anthracycline therapy
Disqualifiers: Non-English speaking, others
No Placebo Group
Trial Summary
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
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.
12345Is 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.
36789How 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.
1011121314Eligibility 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.
I can speak English fluently.
My child's cancer treatment includes anthracycline therapy.
Exclusion Criteria
I do not speak English.
Unable to understand the content of interviews
I am a child cancer survivor not scheduled for anthracycline therapy.
+1 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Real life usability testingExperimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Connecticut Children's Medical CenterHartford, CT
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Who Is Running the Clinical Trial?
Connecticut Children's Medical CenterLead Sponsor
The Hospital for Sick ChildrenCollaborator
References
Feasibility of Weekly Electronic Patient- and Proxy-Reported Outcome Measures in Pediatric Oncology. [2023]Electronic patient-reported outcome measures (ePROMs) benefit adult cancer care, but their use in pediatric cancer care is limited.
The effectiveness of digital self-management interventions on health outcomes among childhood cancer survivors: A systematic review and meta-analysis. [2021]The study aimed to review the evidence about existing digital interventions for childhood cancer survivors and examine their effectiveness on health outcomes.
The Pediatric Cancer Survivors' User Experiences With Digital Health Interventions: A Systematic Review of Qualitative Data. [2022]Evidence suggests that digital health interventions are feasible and acceptable in pediatric cancer survivors. Efforts to synthesize user experiences, however, are limited.
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]mHealth apps have been not been well tested among childhood cancer survivors (CCSs) to track physical and psychosocial functioning for improved self-management of post-treatment needs.
Evaluation of mobile phone applications to support medication adherence and symptom management in oncology patients. [2019]Mobile phone applications (apps), may support pediatric oncology patients with medication and disease management. A scoping review of the literature, a search of the iTunes App and Google Play Stores, was conducted to identify medication and symptom management apps for adult and pediatric oncology patients. Pooled results yielded 28 apps which were assessed for quality using the Mobile Application Rating Scale, with mean overall scores ranging from 2.8 to 4.3. Most apps received low scores in the Engagement domain. Our study assessed the quality of available mobile oncology apps and identified areas for improvement in design and function.
A global approach to long-term follow-up of targeted and immune-based therapy in childhood and adolescence. [2022]While considerable efforts and progress in our understanding of the long-term toxicities of surgery, radiation and chemotherapy in children with cancer have been made over the last 5 decades, there continues to be a wide gap in our knowledge of the long-term health impact of most novel targeted and immunotherapy agents. To address this gap, ACCELERATE, a multi-stakeholder collaboration of clinical and translational academics, regulators from the EMA and FDA, patient/family advocates and members spanning small biotechnology through to large pharmaceutical companies have initiated the development of an international long-term follow-up data registry to collect this important information prospectively. Providing critical safety data on the long-term use of these approved and investigational therapies in children will support the regulatory requirements and labeling information. It will also provide the necessary insight to help guide physicians and families on the appropriateness of a targeted or immune therapy for their child and inform survivorship planning.
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]Children with cancer experience significant toxicities while undergoing treatment. Documentation of adverse events (AEs) in clinical trials is mandated by federal agencies. Although many AEs are subjective, the current standard is clinician reporting. Our long-term goal is to create and validate a self-report measure of subjective AEs for children aged 7 years and older that will inform AE reporting for the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE). This content validation study aimed to identify which of the AEs in the current CTCAE should be included in a pediatric self-report measure.
Development of a Pediatric Adverse Events Terminology. [2019]In 2009, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) established the Pediatric Terminology Harmonization Initiative to establish a core library of terms to facilitate the acquisition and sharing of knowledge between pediatric clinical research, practice, and safety reporting. A coalition of partners established a Pediatric Terminology Adverse Event Working Group in 2013 to develop a specific terminology relevant to international pediatric adverse event (AE) reporting. Pediatric specialists with backgrounds in clinical care, research, safety reporting, or informatics, supported by biomedical terminology experts from the National Cancer Institute's Enterprise Vocabulary Services participated. The multinational group developed a working definition of AEs and reviewed concepts (terms, synonyms, and definitions) from 16 pediatric clinical domains. The resulting AE terminology contains >1000 pediatric diseases, disorders, or clinical findings. The terms were tested for proof of concept use in 2 different settings: hospital readmissions and the NICU. The advantages of the AE terminology include ease of adoption due to integration with well-established and internationally accepted biomedical terminologies, a uniquely temporal focus on pediatric health and disease from conception through adolescence, and terms that could be used in both well- and underresourced environments. The AE terminology is available for use without restriction through the National Cancer Institute's Enterprise Vocabulary Services and is fully compatible with, and represented in, the Medical Dictionary for Regulatory Activities. The terminology is intended to mature with use, user feedback, and optimization.
Adolescents' understanding of chemotherapy-related adverse events: a concept elicitation study. [2022]to document adolescents' understanding of chemotherapy-related core adverse events from the Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events and thus begin the validation process of this tool's items with Brazilian adolescents.
QUARTET: A SIOP Europe project for quality and excellence in radiotherapy and imaging for children and adolescents with cancer. [2022]The European Society for Paediatric Oncology (SIOPE) Radiation Oncology Working Group presents the QUARTET Project: a centralised quality assurance programme designed to standardise care and improve the quality of radiotherapy and imaging for international clinical trials recruiting children and adolescents with cancer throughout Europe. QUARTET combines the paediatric radiation oncology expertise of SIOPE with the infrastructure and experience of the European Organisation for Research and Treatment of Cancer to deliver radiotherapy quality assurance programmes for large, prospective, international clinical trials. QUARTET-affiliated trials include children and adolescents with brain tumours, neuroblastoma, sarcomas including rhabdomyosarcoma, and renal tumours including Wilms' tumour. With nine prospective clinical trials and two retrospective studies within the active portfolio in March 2022, QUARTET will collect one of the largest repositories of paediatric radiotherapy and imaging data, support the clinical assessment of radiotherapy, and evaluate the role and benefit of radiotherapy quality assurance for this cohort of patients within the context of clinical trials.
The role of proton therapy in pediatric malignancies: Recent advances and future directions. [2020]Proton radiotherapy has promised an advantage in safely treating pediatric malignancies with an increased capability to spare normal tissues, reducing the risk of both acute and late toxicity. The past decade has seen the proliferation of more than 30 proton facilities in the United States, with increased capacity to provide access to approximately 3,000 children per year who will require radiotherapy for their disease. We provide a review of the initial efforts to describe outcomes after proton therapy across the common pediatric disease sites. We discuss the main attempts to assess comparative efficacy between proton and photon radiotherapy concerning toxicity. We also discuss recent efforts of multi-institutional registries aimed at accelerating research to better define the optimal treatment paradigm for children requiring radiotherapy for cure.
A dedicated cloud system for real-time upfront quality assurance in pediatric radiation therapy. [2020]Pediatric radiotherapy (RT) is a highly specialized field, requiring great experience to delineate correctly tumor targets and organs at risk. To reduce treatment failures related to planning inaccuracies and to obtain robust clinical results despite the limited numbers of enrolled pediatric patients, the SIOP PNET5MB clinical trial on medulloblastoma requires a real-time, pre-radiation review of the RT treatment (craniospinal irradiation and boost plan) under the direct responsibility of the national coordinator center. Here we describe the centralized radiotherapy quality assurance (QA) program developed in Italy for this purpose.
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]It is increasingly accepted that survival alone is an inadequate measure of the success of childhood brain tumour treatments. Consequently, there is growing emphasis on capturing quality of survival. Ependymomas are the third most frequently occurring brain tumours in childhood and present significant clinical challenges. European Society of Paediatric Oncology Ependymoma II is a comprehensive international program aiming to evaluate outcomes under different treatment regimens and improve diagnostic accuracy. Importantly, there has been agreement to lower the age at which children with posterior fossa ependymoma undergo focal irradiation from three years to either eighteen months or one year of age. Hitherto radiotherapy in Europe had been reserved for children over three years due to concerns over adverse cognitive outcomes following irradiation of the developing brain. There is therefore a duty of care to include longitudinal cognitive follow-up and this has been agreed as an essential trial outcome. Discussions between representatives of 18 participating European countries over 10 years have yielded European consensus for an internationally accepted test battery for follow-up of childhood ependymoma survivors. The 'Core-Plus' model incorporates a two-tier approach to assessment by specifying core tests to establish a minimum dataset where resources are limited, whilst maintaining scope for comprehensive assessment where feasible. The challenges leading to the development of the Core-Plus model are presented alongside learning from the initial stages of the trial. We propose that this model could provide a solution for future international trials addressing both childhood brain tumours and other conditions associated with cognitive morbidity.
Clinical research tools in pediatric oncology: challenges and opportunities. [2020]Survival for childhood cancers has improved significantly over the last decades. However, patient outcomes have plateaued over the last decade for difficult-to-treat diseases. With high cure rates, decreasing long-term toxicities and sequelae remains crucial. Since many advances in childhood cancer research come from the adult oncology world, one of the key areas is improving the adaptation of tools that are essential for clinical trial conduct that were developed for adults into pediatrics. These include tools to evaluate toxicity, quality of life, radiological response, statistical methodology, or indicators of cancer care quality. In this review, we present ongoing international efforts to validate and adapt these tools for children and adolescents and discuss remaining challenges. These efforts will hopefully accelerate and improve the quality of pediatric oncology research in the upcoming years.