Digitalized Exercise Fit Tool Intervention for Adolescents With Blood Cancer
24. juli 2026 oppdatert av: 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)
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Ka Wai Katherine LAM, Doctor of Philosophy
- Telefonnummer: +852 27666420
- E-post: kw-katherine.lam@polyu.edu.hk
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: vanlig omsorg
|
Participants in the control group will receive usual care with treatment and follow-ups from the hospital.
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Screening rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Physical activity (PA) levels
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
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Studer hoveddatoer
Studiestart (Antatt)
20. juli 2026
Primær fullføring (Antatt)
19. juli 2027
Studiet fullført (Antatt)
31. desember 2027
Datoer for studieregistrering
Først innsendt
19. mai 2026
Først innsendt som oppfylte QC-kriteriene
1. juni 2026
Først lagt ut (Faktiske)
2. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- dEFT Adolescent
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