Development and Validation of the EFT for Adolescents With Cancer

• Conditions: Cancer
• Interventions: Other: Testing of the EFT

• Registration Number: NCT05304988
• Lead Sponsor: The Hong Kong Polytechnic University

Brief 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.

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 oncologist for the fitness of subjects for physical activity.

Study Timeline

• Study Start: 2020-09-07
• Study First Submitted: 2021-05-18
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-22
• Last Update Submitted: 2022-03-22
• Study First Posted: 2022-03-31
• Last Update Posted: 2022-03-31
• Primary Completion: 2023-03-06
• Study Completion: 2023-03-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Developing and testing of EFT	Testing of the EFT	It aims to develop a patient-based assessment tool by our research members for adolescents with cancer in Hong Kong.

Primary Outcome Measures

Name	Time	Method
The EFT scores	Just before their scheduled oncologist routine visit	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.

Secondary Outcome Measures

Name	Time	Method
The oncologists' rating for physical activity	Just before their scheduled oncologist routine visit	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.
Numerical Rating Scale (NRS) for pain	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.

Trial Locations

Locations (1)

Katherine Lam; 🇭🇰 Hong Kong, Hong Kong,China, Hong Kong