Hematologic CancerNCT07621887
Digitalized Exercise Fit Tool Intervention for Adolescents With Blood Cancer
A study testing Digitalized Exercise Fit Tool Intervention in people with Hematologic Cancer and Leukaemia, run by The Hong Kong Polytechnic University.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Hematologic Cancer, Leukaemia, Lymphoma
- What is being tested?
- Digitalized Exercise Fit Tool Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- (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.
Who cannot join
- (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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
- Is it feasible to conduct a larger randomised controlled trial of the digitalised EFT intervention?
- Does the digitalised EFT intervention improve physical activity levels, physical activity self-efficacy, and quality of life at 6 months?
Read more
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:
- Receive a 20-minute educational session on how to use the mobile application
- Use the mobile application to self-assess their appropriate physical activity level and exercise with a virtual coach
- Complete questionnaires and wear an accelerometer at 1, 3, and 6 months after enrollment
- Attend a 20-30-minute individual interview at 6 months (intervention group only, 10 participants)
- Conditions
- Hematologic Cancer, Leukaemia, Lymphoma, Physical Activity
- Being tested
- Digitalized Exercise Fit Tool Intervention, Usual Care
- Keywords
- Adolescents, Cancer, Physical activity, Mobile application, Feasibility randomised controlled trial, Exercise Fit Tool, Quality of life, Digital intervention
- Medical subject headings
- Hematologic Neoplasms, Leukemia, Lymphoma, Motor Activity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digitalized Exercise Fit Tool InterventionBehavioural
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.
Usual CareBehavioural
Participants in the control group will receive usual care with treatment and follow-ups from the hospital.
| Study group | Role | What they receive |
|---|---|---|
| Digitalised EFT intervention | Experimental | Not described Receives: Behavioral: Digitalized Exercise Fit Tool Intervention |
| usual care | Placebo comparator | Not described Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening rate
Calculated as the number of participants screened at participating hospital divided by number of participants at participated hospitals during the recruitment period.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Time Point 3 (at 6 months after the intervention)
Secondary outcomes (4)
Physical activity (PA) levels
Physical activity (PA) levels assessed via accelerometers.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start20 Jul 2026 (estimated)
- Primary completion19 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic CancerStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Katherine Lam, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621887
- Sponsor's protocol ID
- dEFT Adolescent
- Status last verified
- Jul 2026
- First submitted
- 19 May 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digitalised Exercise Fit Tool Intervention for Adolescents With Hematologic Cancer
- ClinicalTrials.gov ID
- NCT07621887
- Acronym / sponsor ID
- dEFT Adolescent
- Conditions
- Hematologic Cancer, Leukaemia, Lymphoma, Physical Activity
- Keywords
- Adolescents, Cancer, Physical activity, Mobile application, Feasibility randomised controlled trial, Exercise Fit Tool, Quality of life, Digital intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 19 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is it feasible to conduct a larger randomised controlled trial of the digitalised EFT intervention?
- 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:
- Receive a 20-minute educational session on how to use the mobile application
- Use the mobile application to self-assess their appropriate physical activity level and exercise with a virtual coach
- Complete questionnaires and wear an accelerometer at 1, 3, and 6 months after enrollment
- Attend a 20-30-minute individual interview at 6 months (intervention group only, 10 participants)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digitalised EFT intervention | Experimental | Behavioral: Digitalized Exercise Fit Tool Intervention |
| usual care | Placebo comparator | Behavioral: Usual Care |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- (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.
Key exclusion criteria (3 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digitalized Exercise Fit Tool InterventionParticipants 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. | Behavioural | Digitalised EFT intervention |
| Usual CareParticipants in the control group will receive usual care with treatment and follow-ups from the hospital. | Behavioural | usual care |
Primary outcome
Screening rate
Time frame: 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.
Eligibility rate
Time frame: During the recruitment period (up to 6 months)
Calculated by dividing the number of participants who are eligible by the number who are screened.
Consent rate
Time frame: 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.
Randomization rate
Time frame: 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.
Attendance rate
Time frame: Time Point 1 (at 1 month after intervention)
Calculated by dividing the number of participants who complete the intervention by those who are randomized
Retention rate
Time frame: 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.
Adherence rate
Time frame: 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.
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)
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.
Proportion of missing data
Time frame: 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.
Adverse events
Time frame: 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.
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Digitalized Exercise Fit Tool Intervention in people with Hematologic Cancer and Leukaemia, run by The Hong Kong Polytechnic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ka Wai Katherine LAM, Doctor of Philosophy (+852 27666420, kw-katherine.lam@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening rate (time frame: During the recruitment period (up to 6 months)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.