CancerNCT05304988
Development and Validation of the EFT for Adolescents With Cancer
An observational study of Cancer, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
There is increasing evidence of interventions shown to be effective to promote physical activity in adolescents with cancer. Nevertheless, adolescents with cancer become physically inactive after the end of the interventions. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Cancer
- What is being tested?
- Testing of the EFT
- How many people
- 400 participants
- Where
- 1 siteHong Kong
- Study dates
- 7 Sep 2020to 31 Dec 2025
- Phase
- Observational
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: A convenience sample of 400 adolescents who meet the eligibility criteria will be invited to participate. Subjects will be recruited in non-governmental organizations and Hong Kong Children's Hospital which is the largest hospital in Hong Kong for admitting adolescents with cancer for hospitalization and follow-ups.
Who may be able to join
- Aged 13-18
- are diagnosed with cancer
- are able to communicate in Cantonese and read Chinese
Who cannot join
- Those with physical or cognitive impairments and learning problems, as identified from the medical records, were excluded. Also, those with medical advice that physical activity was not recommended or with detailed exercise prescriptions from physicians or physiotherapists during recruitment were excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Katherine Lam
Hong Kong, Hong Kong,China, 0000
Katherine Lam, Phd
About this study
Official title: Development and Validation of the Exercise Fit Test (EFT) for Adolescents With Cancer
There is increasing evidence of interventions shown to be effective to promote physical activity in adolescents with cancer. Nevertheless, adolescents with cancer become physically inactive after the end of the interventions. These interventions emphasized heavily on interventionists' role to assess adolescents' physical fitness and prescribe exercises. After the intervention, the adolescents were unable to follow the previous exercise prescriptions due to their changing medical conditions. To promote physical activity sustainably, it is vital to develop a patient-based assessment tool to allow adolescents with cancer to self-assess their own appropriate levels of physical activity that they could perform. However, a review of literature indicates a lack of such a tool.
Read the detailed description
A cross-sectional study design will be used. A convenience sample of 400 adolescents who (1) are aged 13-18; (2) are diagnosed with cancer; (3) can communicate in Cantonese and read Chinese will be recruited in Hong Kong Children's Hospital. The outcome measures will include demographic characteristics, pain scores, cardiopulmonary function measurements, EFT scores and ratings of the physiotherapists for the fitness of subjects for physical activity.
- Conditions
- Cancer
- Being tested
- Testing of the EFT
- Keywords
- Adolescents, Physical Activity, Tool
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing of the EFTOther
Our team will develop specific questions in EFT. Then, subject will be invited to fill in a set of questionnaires covering demographic characteristics, EFT items and a numerical rating scale for pain scores. The physiotherapists will rate the subject with the most appropriate level of physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Developing and testing of EFT | It aims to develop a patient-based assessment tool by our research members for adolescents with cancer in Hong Kong. Receives: Other: Testing of the EFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The EFT scores
Subjects will be asked to mark their responses for the EFT items in the second draft just before their scheduled oncologist routine visit. The scale ranges from 1 to 5. Higher scores indicate that the subjects are fit for a higher level of physical activity.
Measured: Just before their scheduled physiotherapists interview
Secondary outcomes (2)
Numerical Rating Scale (NRS) for pain
Subjects will be asked to mark their pain level on the NRS according to their experience just before their scheduled oncologist routine visit. The scale ranges from 0 to 10. Higher scores represent a higher level of pain.
Measured: Just before their scheduled oncologist routine visit
The physiotherapists' rating for physical activity
The physiotherapists will rate the subject with the most appropriate intensity level of physical activity on a 5-point scale. The scale ranges from 1 to 5. Higher scores indicate that the subjects are fit for a higher level of physical activity.
Measured: Just before their scheduled physiotherapist interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start7 Sep 2020
- Primary completion6 Sep 2023
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 400 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
- Investigators
- Katherine Lam, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304988
- Sponsor's protocol ID
- EFT_Adolescents
- Status last verified
- Aug 2025
- First submitted
- 18 May 2021
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of the Exercise Fit Test (EFT) for Adolescents With Cancer
- ClinicalTrials.gov ID
- NCT05304988
- Acronym / sponsor ID
- EFT_Adolescents
- Conditions
- Cancer
- Keywords
- Adolescents, Physical Activity, Tool
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 6 Sep 2023 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 31 Mar 2022 (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.
There is increasing evidence of interventions shown to be effective to promote physical activity in adolescents with cancer. Nevertheless, adolescents with cancer become physically inactive after the end of the interventions. These interventions emphasized heavily on interventionists' role to assess adolescents' physical fitness and prescribe exercises. After the intervention, the adolescents were unable to follow the previous exercise prescriptions due to their changing medical conditions. To promote physical activity sustainably, it is vital to develop a patient-based assessment tool to allow adolescents with cancer to self-assess their own appropriate levels of physical activity that they could perform. However, a review of literature indicates a lack of such a tool.
Detailed description
A cross-sectional study design will be used. A convenience sample of 400 adolescents who (1) are aged 13-18; (2) are diagnosed with cancer; (3) can communicate in Cantonese and read Chinese will be recruited in Hong Kong Children's Hospital. The outcome measures will include demographic characteristics, pain scores, cardiopulmonary function measurements, EFT scores and ratings of the physiotherapists for the fitness of subjects for physical activity.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Developing and testing of EFT | – | Other: Testing of the EFTIt aims to develop a patient-based assessment tool by our research members for adolescents with cancer in Hong Kong. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- A convenience sample of 400 adolescents who meet the eligibility criteria will be invited to participate. Subjects will be recruited in non-governmental organizations and Hong Kong Children's Hospital which is the largest hospital in Hong Kong for admitting adolescents with cancer for hospitalization and follow-ups.
Key inclusion criteria (3 listed)
- Aged 13-18
- are diagnosed with cancer
- are able to communicate in Cantonese and read Chinese
Key exclusion criteria (1 listed)
- Those with physical or cognitive impairments and learning problems, as identified from the medical records, were excluded. Also, those with medical advice that physical activity was not recommended or with detailed exercise prescriptions from physicians or physiotherapists during recruitment were excluded.
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 |
|---|---|---|
| Testing of the EFTOur team will develop specific questions in EFT. Then, subject will be invited to fill in a set of questionnaires covering demographic characteristics, EFT items and a numerical rating scale for pain scores. The physiotherapists will rate the subject with the most appropriate level of physical activity. | Other | Developing and testing of EFT |
Primary outcome
The EFT scores
Time frame: Just before their scheduled physiotherapists interview
Subjects will be asked to mark their responses for the EFT items in the second draft just before their scheduled oncologist routine visit. The scale ranges from 1 to 5. Higher scores indicate that the subjects are fit for a higher level of physical activity.
2 secondary outcomes
Numerical Rating Scale (NRS) for pain
Time frame: Just before their scheduled oncologist routine visit
The physiotherapists' rating for physical activity
Time frame: Just before their scheduled physiotherapist interview
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 20 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Katherine Lam, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Katherine Lam, PhD (27666420, kwkatlam@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The EFT scores (time frame: Just before their scheduled physiotherapists interview). 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 20 Aug 2025.