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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digitalised EFT intervention | Experimental |
| |
| usual care | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digitalized Exercise Fit Tool Intervention | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ka Wai Katherine LAM, Doctor of Philosophy | Contact | +852 27666420 | kw-katherine.lam@polyu.edu.hk |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009043 | Motor Activity |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009370 | Neoplasms by Histologic Type |
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|
| Usual Care | Behavioral | Participants in the control group will receive usual care with treatment and follow-ups from the hospital. |
|
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) |
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) |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001519 | Behavior |