Digitalized Exercise Fit Tool Intervention for Adolescents With Blood Cancer
1 giugno 2026 aggiornato da: 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)
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
30
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Ka Wai Katherine LAM, Doctor of Philosophy
- Numero di telefono: +852 27666420
- Email: kw-katherine.lam@polyu.edu.hk
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore placebo: cure abituali
|
Participants in the control group will receive usual care with treatment and follow-ups from the hospital.
|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Screening rate
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Physical activity (PA) levels
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 giugno 2026
Completamento primario (Stimato)
31 dicembre 2027
Completamento dello studio (Stimato)
31 dicembre 2027
Date di iscrizione allo studio
Primo inviato
19 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
1 giugno 2026
Primo Inserito (Effettivo)
2 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
2 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
1 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- dEFT Adolescent
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .