Aplicação HopeMove em Doentes Pediátricos com Cancro
HopeMove: Viabilidade e Aceitabilidade de uma Aplicação Móvel para Promover Atividade Física em Pacientes de Hematologia e Oncologia Pediátricas
This pilot feasibility study aims to assess the acceptability, usability, safety, and initial effects of the HopeMove mobile health app on fatigue in adolescents aged 13 to 18 years undergoing hematology-oncology treatment. HopeMove is a wearable-compatible app that offers guided home exercise sessions and daily symptom tracking to support physical activity and monitor well-being during treatment. The study includes an expert usability evaluation with 10 clinicians, a one-week usability testing phase with 15 adolescents, and an eight-week intervention period in which participants complete at least three exercise sessions per week using the app. Outcomes include usability measured with the Mobile Application Usability Scale, satisfaction assessed via a Visual Analog Scale, and fatigue evaluated with the Fatigue Scale. The findings are expected to provide evidence on the feasibility, usability, and potential clinical benefits of mobile-supported exercise programs for children and adolescents undergoing cancer treatment.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Adolescents undergoing cancer treatment often face declines in physical function, decreased physical activity, and cancer-related fatigue, all of which negatively impact their quality of life and treatment adherence. Reduced activity and extended hospital stays can worsen fatigue and emotional distress, limiting daily activities and overall well-being. Exercise-based supportive care programs have proven beneficial in pediatric oncology, but access to structured, developmentally suitable options remains limited. Mobile health solutions are emerging as a way to support physical activity and symptom monitoring through accessible digital platforms.
HopeMove is a mobile app designed to encourage physical activity and symptom tracking among adolescents aged 13-18 years receiving hematology-oncology treatment. The app features short guided exercise videos, daily symptom diaries, weekly activity summaries, and compatibility with wearable devices.
The evaluation was carried out in three successive phases. First, 10 clinical experts reviewed the app using the Mobile Application Usability Scale to evaluate clarity, usability, and clinical appropriateness. Next, 15 adolescents participated in a one-week usability test, during which they used the app and provided structured feedback. In addition to quantitative usability scores, adolescents completed an 8-item open-ended interview developed by the research team to assess ease of use, clarity of instructions, comfort during exercise, content relevance, and expectations. Feedback from experts and adolescents was combined to improve the app before proceeding.
In the third phase, the same 15 adolescents used HopeMove over eight weeks. They were instructed to complete at least three guided exercise sessions weekly, with the option for additional sessions. During the intervention, adolescents also performed daily in-app symptom check-ins responding to "How do you feel today?" with a visual rating scale to record their overall perceived condition each day. Fatigue was measured at baseline and after the intervention using the Fatigue Scale, and satisfaction was assessed with a Visual Analog Scale. Adherence, usability, and safety were monitored throughout, with no adverse events reported.
This pilot feasibility study aims to assess the usability, acceptability, safety, and preliminary clinical effects of the HopeMove app in adolescents receiving hematology-oncology treatment. Results are expected to provide evidence supporting the potential benefits of mobile app-based exercise interventions for children and adolescents undergoing cancer treatment and to inform the design of future controlled trials.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Istanbul, Turquia (Türkiye)
- Istanbul University
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- adolescents aged 13-18 years
- receiving active hematology-oncology treatment
- able to use a smartphone running Android operating system
- has internet access
- voluntarily agrees to participate
- parent/guardian consent obtained (if applicable)
- able to perform light-moderate exercise
- able to complete at least 75% of planned exercise sessions
Exclusion Criteria:
- having a chronic illness requiring regular invasive procedures,
- having received analgesics within the past 2 hours,
- having experienced a seizure within the past 2 hours,
- using antiepileptic medication,
- having a body temperature above 37.5°C
- not having parental consent,
- being agitated at the time of the procedure,
- having any auditory or visual impairments.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Intervention Group-HopeMove Application Group
Participants assigned to the HopeMove Application Group will use HopeMove, a mobile application designed to promote and support physical activity among pediatric hematology and oncology patients. During the 4-week feasibility period, participants are instructed to engage with the application at least 3 days per week, completing the guided physical activity sessions provided within the app. |
HopeMove is a mobile application developed to promote physical activity and support wellbeing among pediatric hematology-oncology patients. The application provides age-appropriate guided exercise sessions, motivational prompts, visual progress tracking, and individualized activity suggestions tailored to each participant's needs and abilities. During the feasibility study, participants were instructed to engage with the HopeMove application at least three days per week for a total duration of four weeks. Each session included structured physical activity modules designed to be safe and achievable during hospitalization or home recovery. The intervention focused on feasibility, usability, acceptability, and preliminary effects on outcomes such as fatigue and satisfaction. No masking was applied due to the nature of the digital intervention. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mobile Application Usability
Prazo: Prior to the initiation of the pilot trial (single assessment during the development phase)
|
Mobile application usability was evaluated prior to the pilot study by a panel of experts in pediatric oncology, digital health, and user-centered design. Experts assessed the HopeMove application using a standardized usability assessment form that examined clarity of content, ease of navigation, appropriateness for the target age group, visual design, responsiveness, and overall user experience. Feedback from experts was used to refine and optimize the application before initiating the pilot trial. |
Prior to the initiation of the pilot trial (single assessment during the development phase)
|
|
Fatigue
Prazo: Baseline (initial meeting) and Week 4 (end of feasibility period)
|
Fatigue levels were assessed to evaluate the preliminary effectiveness of the HopeMove mobile application. Fatigue was measured using a standardized pediatric fatigue assessment tool administered before the intervention (at the initial meeting) and at the end of the 4-week feasibility period. Changes in fatigue scores were examined to explore whether engagement with the application was associated with improvements in perceived fatigue among participants. |
Baseline (initial meeting) and Week 4 (end of feasibility period)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Satisfaction for Mobile Application
Prazo: Week 4 (end of feasibility period)
|
Participant satisfaction with the HopeMove mobile application was evaluated to assess overall acceptability of the intervention. Satisfaction was measured using a structured satisfaction questionnaire administered at the end of the 4-week feasibility period. The questionnaire assessed perceived usefulness, enjoyment, clarity of instructions, willingness to continue using the app, and overall satisfaction. Higher scores indicated greater satisfaction with the intervention. |
Week 4 (end of feasibility period)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- KOCUN
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Individual participant data (IPD) will not be shared because the dataset contains identifiable health information of pediatric participants, and sharing is restricted to protect patient privacy in accordance with ethical and legal requirements.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .