NCT07621887

Brief Summary

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. 1.Is it feasible to conduct a larger randomised controlled trial of the digitalised EFT intervention?
  2. 2.Does the digitalised EFT intervention improve physical activity levels, physical activity self-efficacy, and quality of life at 6 months?
  3. 3.Receive a 20-minute educational session on how to use the mobile application
  4. 4.Use the mobile application to self-assess their appropriate physical activity level and exercise with a virtual coach
  5. 5.Complete questionnaires and wear an accelerometer at 1, 3, and 6 months after enrollment
  6. 6.Attend a 20-30-minute individual interview at 6 months (intervention group only, 10 participants)

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
19mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Dec 2027

First Submitted

Initial submission to the registry

May 19, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

June 2, 2026

Status Verified

June 1, 2026

Enrollment Period

1.6 years

First QC Date

May 19, 2026

Last Update Submit

June 1, 2026

Conditions

Hematologic CancerLeukaemiaLymphomaPhysical Activity

Keywords

AdolescentsCancerPhysical activityMobile applicationFeasibility randomised controlled trialExercise Fit ToolQuality of lifeDigital intervention

Outcome Measures

Primary Outcomes (10)

  • Screening rate

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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)

Secondary Outcomes (4)

  • Physical activity (PA) levels

    Time Point 1 (at 1 month after intervention), Time Point 3 (at 6 months after the intervention)

  • Physical activity (PA) levels

    Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention)

  • Physical Activity Self-Efficacy (PASE)

    Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention)

  • Quality of life (QoL)

    Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention)

Study Arms (2)

Digitalised EFT intervention

EXPERIMENTAL
Behavioral: Digitalized Exercise Fit Tool Intervention

usual care

PLACEBO COMPARATOR
Behavioral: Usual Care

Interventions

Digitalized Exercise Fit Tool InterventionBEHAVIORAL

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.

Digitalised EFT intervention
Usual CareBEHAVIORAL

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

usual care

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • (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.

You may not qualify if:

  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hematologic NeoplasmsLeukemiaLymphomaMotor ActivityNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBehavior

Central Study Contacts

Ka Wai Katherine LAM, Doctor of Philosophy

CONTACT

+852 27666420kw-katherine.lam@polyu.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 19, 2026

First Posted

June 2, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

June 2, 2026

Record last verified: 2026-06