Digitalized Exercise Fit Tool Intervention for Adolescents With Blood Cancer
24 de julio de 2026 actualizado por: Dr Katherine Lam, The Hong Kong Polytechnic University
Digitalised Exercise Fit Tool Intervention for Adolescents With Hematologic Cancer
The goal of this clinical trial is to learn if a digitalised Exercise Fit Tool (EFT) mobile application can promote physical activity in adolescents aged 12-18 years who have completed treatment for hematologic cancer (e.g., leukaemia and lymphoma). The main questions it aims to answer are:
- Is it feasible to conduct a larger randomised controlled trial of the digitalised EFT intervention?
- Does the digitalised EFT intervention improve physical activity levels, physical activity self-efficacy, and quality of life at 6 months?
Researchers will compare the digitalised EFT intervention group to a usual care group to see if the mobile application can promote physical activity levels, physical activity self-efficacy, and quality of life in adolescents with hematologic cancer.Participants will:
- Receive a 20-minute educational session on how to use the mobile application
- Use the mobile application to self-assess their appropriate physical activity level and exercise with a virtual coach
- Complete questionnaires and wear an accelerometer at 1, 3, and 6 months after enrollment
- Attend a 20-30-minute individual interview at 6 months (intervention group only, 10 participants)
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
30
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Ka Wai Katherine LAM, Doctor of Philosophy
- Número de teléfono: +852 27666420
- Correo electrónico: kw-katherine.lam@polyu.edu.hk
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- (1) they are 12-18 years old;
- (2) they had been diagnosed with hematologic cancer such as leukaemia and lymphoma;
- (3) they are regarded by the responsible physicians as stable, able to conduct PA, and without any PA restrictions,
- (4) they completed all cancer treatment;
- (5) they speak Cantonese and read Chinese.
Exclusion Criteria:
- (1) Receiving palliative care
- (2) Have physical or cognitive impairment and learning problems as identified from medical records
- (3) Identified by physicians that no physical activity should be conducted at the time of recruitment
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador de placebos: cuidado usual
|
Participants in the control group will receive usual care with treatment and follow-ups from the hospital.
|
|
Experimental: Digitalised EFT intervention
|
Participants in the intervention group will be delivered a 20-minute educational session to the participants.
During this session, participants will be educated about the introduction and operation of the mobile application.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Screening rate
Periodo de tiempo: During the recruitment period (up to 6 months)
|
Calculated as the number of participants screened at participating hospital divided by number of participants at participated hospitals during the recruitment period.
|
During the recruitment period (up to 6 months)
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Eligibility rate
Periodo de tiempo: During the recruitment period (up to 6 months)
|
Calculated by dividing the number of participants who are eligible by the number who are screened.
|
During the recruitment period (up to 6 months)
|
|
Consent rate
Periodo de tiempo: During the recruitment period (up to 6 months)
|
Calculated by dividing the number of participants who consent to join the study by the number who are eligible.
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During the recruitment period (up to 6 months)
|
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Randomization rate
Periodo de tiempo: Time Point 1 (at 1 month after intervention)
|
Calculated by dividing the number of participants who are randomized into intervention and control groups by those who provide consent.
|
Time Point 1 (at 1 month after intervention)
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Attendance rate
Periodo de tiempo: Time Point 1 (at 1 month after intervention)
|
Calculated by dividing the number of participants who complete the intervention by those who are randomized
|
Time Point 1 (at 1 month after intervention)
|
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Retention rate
Periodo de tiempo: Time Point 3 (at 6 months after intervention)
|
Calculated by dividing the number of participants who remain in the study by those who are randomized.
Retention rates for the intervention and control groups will be calculated at each follow-up.
|
Time Point 3 (at 6 months after intervention)
|
|
Adherence rate
Periodo de tiempo: Time Point 1 (at 1 month after intervention)
|
Calculated by dividing the number of participants students who follow the intervention protocol by those who are randomized.
|
Time Point 1 (at 1 month after intervention)
|
|
Complete rate
Periodo de tiempo: Time Point 1 (at 1 month after the intervention), Time Point 2 (at 3 month after intervention), Time Point 3 (at 6 months after intervention)
|
Calculated by dividing the number of participants who returned questionnaires by the number of questionnaires distributed.
This will be calculated by groups at baseline and each follow-up.
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Time Point 1 (at 1 month after the intervention), Time Point 2 (at 3 month after intervention), Time Point 3 (at 6 months after intervention)
|
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Proportion of missing data
Periodo de tiempo: Time Point 3 (at 6 months after the intervention)
|
Calculated as the percentage of missing values in the dataset.
Unknown or blank values will be considered missing values.
|
Time Point 3 (at 6 months after the intervention)
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Adverse events
Periodo de tiempo: Time Point 3 (at 6 months after the intervention)
|
Adverse events are defined as unfavourable and unintended events that are not present at baseline or appear to have worsened during the study.
|
Time Point 3 (at 6 months after the intervention)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Physical activity (PA) levels
Periodo de tiempo: Time Point 1 (at 1 month after intervention), Time Point 3 (at 6 months after the intervention)
|
Physical activity (PA) levels assessed via accelerometers.
|
Time Point 1 (at 1 month after intervention), Time Point 3 (at 6 months after the intervention)
|
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Physical activity (PA) levels
Periodo de tiempo: Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention)
|
Physical activity (PA) levels assessed via self-reports.
|
Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention)
|
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Physical Activity Self-Efficacy (PASE)
Periodo de tiempo: Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention)
|
It comprises five items on a three-point Likert scale, with scores ranging from 5 to 15.
Higher scores indicate higher levels of PASE.
Its psychometric properties have been examined in Chinese adolescents with cancer, with good content validity and test.
|
Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention)
|
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Quality of life (QoL)
Periodo de tiempo: Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention)
|
Participants' QoL will be measured using child specific EQ-5D-Y-5L scale, which is validated in ages 8-15 via self-report.
A published algorithm will be used to convert the scores into a single utility score.
Scores range from 0 to 100, with higher scores indicating better QoL
|
Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
20 de julio de 2026
Finalización primaria (Estimado)
19 de julio de 2027
Finalización del estudio (Estimado)
31 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
19 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
1 de junio de 2026
Publicado por primera vez (Actual)
2 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
24 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Enfermedades hematológicas
- Enfermedades linfáticas
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Comportamiento
- Enfermedades hemic y linfáticas
- Neoplasias
- Leucemia
- Neoplasias Hematológicas
- Linfoma
- Actividad del motor
Otros números de identificación del estudio
- dEFT Adolescent
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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