Hematologic Cancer, Leukaemia, Lymphoma, Physical Activity
Conditions
Keywords
Adolescents, Cancer, Physical activity, Mobile application, Feasibility randomised controlled trial, Exercise Fit Tool, Quality of life, Digital intervention
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. 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
BEHAVIORALDigitalized 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.
BEHAVIORALUsual Care
Participants in the control group will receive usual care with treatment and follow-ups from the hospital.
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Screening rate | 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 | 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 | 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 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 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 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 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 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 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 assessed via accelerometers. |
| Physical Activity Self-Efficacy (PASE) | Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention) | 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. |
| Quality of life (QoL) | Time Point 1 (at 1 month after the intervention), Time Point 3 (at 6 months after the intervention) | 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 |
Contacts
CONTACTKa Wai Katherine LAM, Doctor of Philosophy
Outcome results
None listed