Digitalized Exercise Fit Tool Intervention for Adolescents With Blood Cancer

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Lymphoma; Physical Activity; Hematologic Cancer; Leukaemia
• Intervention / Treatment: Behavioral: Digitalized Exercise Fit Tool Intervention; Behavioral: Usual Care

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ka Wai Katherine LAM, Doctor of Philosophy; Phone Number: +852 27666420; Email: kw-katherine.lam@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: usual care	Behavioral: Usual Care; Participants in the control group will receive usual care with treatment and follow-ups from the hospital.
Experimental: Digitalised EFT intervention	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity (PA) levels	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	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)	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)	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)

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 19, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Adolescents; Cancer; Quality of life; Physical activity; Digital intervention; Mobile application; Feasibility randomised controlled trial; Exercise Fit Tool
• Additional Relevant MeSH Terms: Neoplasms by Site; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Behavior; Hemic and Lymphatic Diseases; Neoplasms; Leukemia; Hematologic Neoplasms; Lymphoma; Motor Activity
• Other Study ID Numbers: dEFT Adolescent

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No