Development and Validation of Perceived Fatigue Meaning Scale on Walking Program

Not Applicable

• Conditions: Gastric Cancer
• Interventions: Behavioral: walking

• Registration Number: NCT01178775
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

The aims of this three-year study are to:

1. develop and validate a perceived meaning of fatigue scale

2. 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

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.

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2010-03
• Study First Submitted: 2010-04-11
• Status Verified: 2010-08
• Study First Submitted QC: 2010-08-09
• Last Update Submitted: 2010-08-09
• Study First Posted: 2010-08-10
• Last Update Posted: 2010-08-10
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• The patients with gastric cancer during receiving chemotherapy
• Those who are willing to participate in the research
• Aged above 18

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	walking	education and education and walking program design

Primary Outcome Measures

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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan