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Digitalized Exercise Fit Tool Intervention for Adolescents With Blood Cancer

24 juli 2026 uppdaterad 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:

  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)

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

30

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: vanlig skötsel
Beteende: Usual Care
Participants in the control group will receive usual care with treatment and follow-ups from the hospital.
Experimentell: Digitalised EFT intervention
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Screening rate
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Physical activity (PA) levels
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

The Hong Kong Polytechnic University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

20 juli 2026

Primärt slutförande (Beräknad)

19 juli 2027

Avslutad studie (Beräknad)

31 december 2027

Studieregistreringsdatum

Först inskickad

19 maj 2026

Först inskickad som uppfyllde QC-kriterierna

1 juni 2026

Första postat (Faktisk)

2 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • dEFT Adolescent

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