Development and Validation of the EFT for Adolescents With Cancer

Cancer Clinical Trial

Official title:

Development and Validation of the Exercise Fit Test (EFT) for Adolescents With Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05304988
• Other study ID #: EFT_Adolescents
• Status: Active, not recruiting
• Start date: September 7, 2020
• Est. completion date: March 6, 2023

Study information

• Verified date: March 2022
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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 oncologist for the fitness of subjects for physical activity.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: March 6, 2023
• Est. primary completion date: March 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

Inclusion Criteria:

• Aged 13-18

• are diagnosed with cancer

• are able to communicate in Cantonese and read Chinese

Exclusion Criteria:

• with physical or cognitive impairment and learning problems as identified from the medical records

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Testing of the EFT
A research committee which composes of a paediatric oncologist, a ward manager, an assistant professor and a research assistant will be set up. The committee will develop specific questions in EFT and design and implement the clinical 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 oncologist will rate the subject with the most appropriate level of physical activity on a 4-point scale.

Locations

Country	Name	City	State
Hong Kong	Katherine Lam	Hong Kong	Hong Kong,China

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 4. Higher scores indicate that the subjects are fit for a higher level of physical activity.	Just before their scheduled oncologist routine visit
Secondary	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.	Just before their scheduled oncologist routine visit
Secondary	The oncologists' rating for physical activity	The oncologists will rate the subject with the most appropriate intensity level of physical activity on a 4-point scale. The scale ranges from 1 to 4. Higher scores indicate that the subjects are fit for a higher level of physical activity.	Just before their scheduled oncologist routine visit