Development and Validation of Perceived Fatigue Meaning Scale on Walking Program

Gastric Cancer Clinical Trial

— PFMS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01178775
• Other study ID #: 200807050R
• Status: Recruiting
• Phase: N/A
• First received: April 11, 2010
• Last updated: August 9, 2010
• Start date: September 2008
• Est. completion date: December 2011

Study information

• Verified date: August 2010
• Source: National Taiwan University Hospital
• Contact: Shiow-Ching Shun, Ph.D
• Phone: 886-2-2312-3456
• Email: scshun[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: December 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• The patients with gastric cancer during receiving chemotherapy

• Those who are willing to participate in the research

• Aged above 18

Study Design

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

Related Conditions & MeSH terms

• Gastric Cancer

Intervention

Behavioral:
• walking
use a pedometer for records steps.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 .	No