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Digitalized Exercise Fit Tool Intervention for Adolescents With Blood Cancer

1. Juni 2026 aktualisiert von: 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)

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

30

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: übliche Pflege
Verhalten: Usual Care
Participants in the control group will receive usual care with treatment and follow-ups from the hospital.
Experimental: Digitalised EFT intervention
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Screening rate
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Physical activity (PA) levels
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

The Hong Kong Polytechnic University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2027

Studienabschluss (Geschätzt)

31. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

19. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Juni 2026

Zuerst gepostet (Tatsächlich)

2. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • dEFT Adolescent

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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