Development and Validation of Perceived Fatigue Meaning Scale on Walking Program (PFMS)
Recruitment status was: Recruiting
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|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|
- Fatigue Symptom Inventory [ Time Frame: Time point(s) at which outcome measure is assessed at 16 Weeks after recruting in this study . ] [ Designated as safety issue: No ]the level of fatigue in three groups will be measured at the end of intervention
|Study Start Date:||September 2008|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
No Intervention: 1
No Intervention: 2
education only group
education and education and walking program design
use a pedometer for records steps.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01178775
|National Taiwan University Hospital|
|Principal Investigator:||Shiow-Ching Shun, Ph.D||National Taiwan University|