Development and Validation of Perceived Fatigue Meaning Scale on Walking Program — PFMS  

Gastric Cancer Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Gastric Cancer

• NCT number: NCT01178775
• Study type: Interventional
• Source: National Taiwan University Hospital
• Contact: Shiow-Ching Shun, Ph.D
• Phone: 886-2-2312-3456
• Email: scshun@ntu.edu.tw
• Status: Recruiting
• Phase: N/A
• Start date: September 2008
• Completion date: December 2011