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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05696275
Other study ID # N202208012
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 16, 2023
Est. completion date December 31, 2024

Study information

Verified date January 2023
Source Taipei Medical University
Contact Tsai-Wei Huang, PhD
Phone +886-2-27361661
Email tsaiwei@tmu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is expected to propose an industry-university cooperation research case for the next two years. When cancer patients use ePRO to record subjective fatigue, and smart watches with 4G communication record objective fatigue, they will be given according to the patient's current degree of mild, moderate and severe fatigue. Suffer from 'exercise or activity' advice and lead the implementation of appropriate exercise advice. This study is expected to design aerobic + anaerobic exercise suitable for mild or moderate patients, and use the sensor of the smart watch to monitor the effect of exercise and fatigue. To sum up, the first-year plan is expected to use the established ePRO electronic records, combined with the LINE communication system, to integrate into a "cancer-related fatigue electronic registration and care system"; the second-year plan will integrate objective fatigue classifiers, Establish the exercise care option in the fatigue care system, and use the smart watch to establish a technology record function of the exercise process to help track the fatigue level of cancer patients.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: 1. age 20 years old; 2. diagnosis of cancer; 3. can continuous wearing bracelet for 14 days or more Exclusion Criteria: 1. Unclear and unable to answer the questionnaire; 2. Not able to walk; 3. platelet <50,000/mm3; 4. ANC 500/cumm

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
exercise
20-30 minutes of walking and elastic band exercise per day

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University

Outcome

Type Measure Description Time frame Safety issue
Primary cancer fatigue--BFI severity of fatigue level; measurement tool: Brief Fatigue Index Change from Baseline post exercise 5 min
Primary cancer fatigue--BFI severity of fatigue level; measurement tool: Brief Fatigue Index Change from Baseline at 1 month.
Secondary Physical Activity assessment--IPAQ International Physical Activity Questionnaire (IPAQ), the questionnaire consists of seven questions regarding types of physical activity that constitute elements of everyday life. The questions refer to physical activity in the last seven days and concern the time spent sitting and walking as well as the time devoted to vigorous and moderate physical activity. Activities done for at least 10 min at a time are taken into account. This instrument is used to assess physical activity levels-according to the IPAQ scoring protocol, three levels are distinguished, i.e., low, moderate and high. Change from Baseline post exercise 5 min
Secondary Physical Activity assessment--IPAQ International Physical Activity Questionnaire (IPAQ), the questionnaire consists of seven questions regarding types of physical activity that constitute elements of everyday life. The questions refer to physical activity in the last seven days and concern the time spent sitting and walking as well as the time devoted to vigorous and moderate physical activity. Activities done for at least 10 min at a time are taken into account. This instrument is used to assess physical activity levels-according to the IPAQ scoring protocol, three levels are distinguished, i.e., low, moderate and high. Change from Baseline at 1 month.
Secondary Chinese version of the Edmonton Symptom Assessment System,C-ESAS The ESAS includes 11 symptoms: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, sleep, well-being, shortness of breath, and other. It uses a 0-10 numerical scale: 0 shows the absence of a symptom, and 10 shows the worst experience of the symptom. Change from Baseline post exercise 5 min
Secondary Chinese version of the Edmonton Symptom Assessment System,C-ESAS The ESAS includes 11 symptoms: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, sleep, well-being, shortness of breath, and other. It uses a 0-10 numerical scale: 0 shows the absence of a symptom, and 10 shows the worst experience of the symptom. Change from Baseline at 1 month.
Secondary Sleep quality--PSQI Pittsburgh Sleep Quality Index (PSQI) scores, is used to assess the quality of sleep of patients - with scores ranging from 0 to 21 - with lower scores indicating better sleep quality. Change from Baseline post exercise 5 min
Secondary Sleep quality--PSQI Pittsburgh Sleep Quality Index (PSQI) scores, is used to assess the quality of sleep of patients - with scores ranging from 0 to 21 - with lower scores indicating better sleep quality. Change from Baseline at 1 month.
Secondary Steps count more steps means good for ability Change from Baseline post exercise 5 min
Secondary Steps count more steps means good for ability Change from Baseline at 1 month.
Secondary walking distance Longer distances mean better movement Change from Baseline post exercise 5 min
Secondary walking distance Longer distances mean better movement Change from Baseline at 1 month.
Secondary strength ability Muscle strength is measured with a muscle strength meter, and an increase in value means an increase in muscle strength Change from Baseline post exercise 5 min
Secondary strength ability Muscle strength is measured with a muscle strength meter, and an increase in value means an increase in muscle strength Change from Baseline at 1 month.
Secondary Smart bracelet_Heart rate variability (HRV) HRV is the physiological phenomenon of the variation in the time interval between consecutive heartbeats in milliseconds. A normal, healthy heart does not tick evenly like a metronome, but instead, when looking at the milliseconds between heartbeats, there is constant variation. Continue wear bracelet five days to record HRV data.
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