Digitalized Exercise Fit Tool Intervention for Adolescents With Blood Cancer
24 juillet 2026 mis à jour par: 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)
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
30
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Ka Wai Katherine LAM, Doctor of Philosophy
- Numéro de téléphone: +852 27666420
- E-mail: kw-katherine.lam@polyu.edu.hk
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: soins habituels
|
Participants in the control group will receive usual care with treatment and follow-ups from the hospital.
|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Screening rate
Délai: 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)
|
|
Eligibility rate
Délai: 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
Délai: 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.
|
During the recruitment period (up to 6 months)
|
|
Randomization rate
Délai: 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)
|
|
Attendance rate
Délai: 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)
|
|
Retention rate
Délai: 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
Délai: 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
Délai: 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.
|
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)
|
|
Proportion of missing data
Délai: 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)
|
|
Adverse events
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Physical activity (PA) levels
Délai: 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)
|
|
Physical activity (PA) levels
Délai: 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)
|
|
Physical Activity Self-Efficacy (PASE)
Délai: 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)
|
|
Quality of life (QoL)
Délai: 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)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
20 juillet 2026
Achèvement primaire (Estimé)
19 juillet 2027
Achèvement de l'étude (Estimé)
31 décembre 2027
Dates d'inscription aux études
Première soumission
19 mai 2026
Première soumission répondant aux critères de contrôle qualité
1 juin 2026
Première publication (Réel)
2 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
27 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- dEFT Adolescent
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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