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Not yet recruiting NCT07621887

Digitalized Exercise Fit Tool Intervention for Adolescents With Blood Cancer

No phase Interventional Hematologic Cancer Leukaemia Lymphoma Physical Activity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Digitalized Exercise Fit Tool Intervention, Usual Care.
Who it may be relevant to
Registry conditions: Hematologic Cancer, Leukaemia, Lymphoma, Physical Activity. Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Digitalised Exercise Fit Tool Intervention for Adolescents With Hematologic Cancer

Overview

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)

Interventions

  • Behavioral 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.
  • Behavioral Usual Care
    Participants in the control group will receive usual care with treatment and follow-ups from the hospital.

Primary outcome measures

  • Screening rate [Time frame: During the recruitment period (up to 6 months)]
  • Eligibility rate [Time frame: During the recruitment period (up to 6 months)]
  • Consent rate [Time frame: During the recruitment period (up to 6 months)]
  • Randomization rate [Time frame: Time Point 1 (at 1 month after intervention)]
  • Attendance rate [Time frame: Time Point 1 (at 1 month after intervention)]
  • Retention rate [Time frame: Time Point 3 (at 6 months after intervention)]
  • Adherence rate [Time frame: Time Point 1 (at 1 month after intervention)]
  • Complete rate [Time frame: 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 [Time frame: Time Point 3 (at 6 months after the intervention)]
  • Adverse events [Time frame: Time Point 3 (at 6 months after the intervention)]
Secondary outcome measures (4)
  • Physical activity (PA) levels [Time frame: Time Point 1 (at 1 month after intervention), Time Point 3 (at 6 months after the intervention)]
  • Physical activity (PA) levels [Time frame: Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention)]
  • Physical Activity Self-Efficacy (PASE) [Time frame: Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention)]
  • Quality of life (QoL) [Time frame: Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07621887 · dEFT Adolescent

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗