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Digitalized Exercise Fit Tool Intervention for Adolescents With Blood Cancer

24 juli 2026 bijgewerkt door: 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:

  1. Is it feasible to conduct a larger randomised controlled trial of the digitalised EFT intervention?
  2. 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:

  1. Receive a 20-minute educational session on how to use the mobile application
  2. Use the mobile application to self-assess their appropriate physical activity level and exercise with a virtual coach
  3. Complete questionnaires and wear an accelerometer at 1, 3, and 6 months after enrollment
  4. Attend a 20-30-minute individual interview at 6 months (intervention group only, 10 participants)

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

30

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Gebruikelijke zorg
Gedragsmatig: Usual Care
Participants in the control group will receive usual care with treatment and follow-ups from the hospital.
Experimenteel: Digitalised EFT intervention
Gedragsmatig: Digitalized Exercise Fit Tool 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Screening rate
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Physical activity (PA) levels
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

The Hong Kong Polytechnic University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

20 juli 2026

Primaire voltooiing (Geschat)

19 juli 2027

Studie voltooiing (Geschat)

31 december 2027

Studieregistratiedata

Eerst ingediend

19 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

1 juni 2026

Eerst geplaatst (Werkelijk)

2 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

27 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

24 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • dEFT Adolescent

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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