- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05304988
Development and Validation of the EFT for Adolescents With Cancer
August 15, 2025 updated by: Dr Katherine Lam, The Hong Kong Polytechnic University
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.
Study Overview
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 Type
Observational
Enrollment (Estimated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Katherine Lam, PhD
- Phone Number: 27666420
- Email: kwkatlam@polyu.edu.hk
Study Contact Backup
- Name: Eva Ho, PhD
- Phone Number: 27666417
- Email: kyeva.ho@polyu.edu.hk
Study Locations
-
-
Hong Kong,China
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Hong Kong, Hong Kong,China, Hong Kong, 0000
- Recruiting
- Katherine Lam
-
Contact:
- Katherine Lam, Phd
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- Aged 13-18
- are diagnosed with cancer
- are able to communicate in Cantonese and read Chinese
Exclusion Criteria:
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Just before their scheduled physiotherapists interview
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numerical Rating Scale (NRS) for pain
Time Frame: Just before their scheduled oncologist routine visit
|
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.
|
Just before their scheduled oncologist routine visit
|
|
The physiotherapists' rating for physical activity
Time Frame: Just before their scheduled physiotherapist interview
|
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.
|
Just before their scheduled physiotherapist interview
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Katherine Lam, PhD, The Hong Kong Polytechnic University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 7, 2020
Primary Completion (Actual)
September 6, 2023
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
May 18, 2021
First Submitted That Met QC Criteria
March 22, 2022
First Posted (Actual)
March 31, 2022
Study Record Updates
Last Update Posted (Actual)
August 20, 2025
Last Update Submitted That Met QC Criteria
August 15, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EFT_Adolescents
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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