Development and Validation of Perceived Fatigue Meaning Scale on Walking Program

Study Overview
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Brief Summary
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The aims of this three-year study are to: develop and validate a perceived meaning of fatigue scale examine the effect of individualized patient education and walking programs on alleviating fatigue in patients with gastric or colorectal cancer,and further explore the relationship between the perceived meaning of fatigue and intervention outcome.

Detailed Description
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In the first year, patients will be recruited from oncology inpatient wards and outpatient clinics in two medical center hospitals in Taipei. Purposive sampling will be used to recruit outpatients or inpatients receiving chemotherapy. Data will be analyzed by descriptive analysis, independent t-test, Pearson correlation, one-way analysis of variance, and exploratory factor analysis. In the second and third years, an experimental design consisting of three groups including a control group, an education only group, and an education and walking program group will be used. Data will be collected at treatment weeks 1, 4,8,12,16 including three cycles of chemotherapy. Data will be analyzed by descriptive analysis, independent t-test, Pearson correlation, and generalized estimating equations. At least 230 subjects will be interviewed in the first year. At least 105 of patients with gastric cancer or colorectal will be classified into the three groups in the second and third year. We expect the results of this study to explore the meaning of fatigue and to help develop a common strategy to manage fatigue in Taiwan. The results can help clinicians and researchers to tailor interventions for cancer patients with severe fatigue.

Official Title
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Development and Validation of Perceived Fatigue Meaning Scale and Its Effect on Individualized Patient Education and Walking Program for Managing Fatigue in Patients With Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Behavioral: walking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients with gastric cancer during receiving chemotherapy Those who are willing to participate in the research Aged above 18

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>control design | |
| No Intervention: 2<br>education only group | |
| Experimental: 3<br>education and education and walking program design | Behavioral: walking<br>* use a pedometer for records steps.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue Symptom Inventory | the level of fatigue in three groups will be measured at the end of intervention | Time point(s) at which outcome measure is assessed at 16 Weeks after recruting in this study . | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fatigue, meaning, education, walking program