Development and Validation of Perceived Fatigue Meaning Scale on Walking Program (PFMS)
Primary Purpose
Gastric Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
walking
Sponsored by
About this trial
This is an interventional supportive care trial for Gastric Cancer focused on measuring fatigue, meaning, education, walking program
Eligibility Criteria
Inclusion Criteria:
- The patients with gastric cancer during receiving chemotherapy
- Those who are willing to participate in the research
- Aged above 18
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
No Intervention
Experimental
Arm Label
1
2
3
Arm Description
control design
education only group
education and education and walking program design
Outcomes
Primary Outcome Measures
Fatigue Symptom Inventory
the level of fatigue in three groups will be measured at the end of intervention
Secondary Outcome Measures
Full Information
NCT ID
NCT01178775
First Posted
April 11, 2010
Last Updated
August 9, 2010
Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT01178775
Brief Title
Development and Validation of Perceived Fatigue Meaning Scale on Walking Program
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2010 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
fatigue, meaning, education, walking program
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
control design
Arm Title
2
Arm Type
No Intervention
Arm Description
education only group
Arm Title
3
Arm Type
Experimental
Arm Description
education and education and walking program design
Intervention Type
Behavioral
Intervention Name(s)
walking
Intervention Description
use a pedometer for records steps.
Primary Outcome Measure Information:
Title
Fatigue Symptom Inventory
Description
the level of fatigue in three groups will be measured at the end of intervention
Time Frame
Time point(s) at which outcome measure is assessed at 16 Weeks after recruting in this study .
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patients with gastric cancer during receiving chemotherapy
Those who are willing to participate in the research
Aged above 18
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiow-Ching Shun, Ph.D
Phone
886-2-2312-3456
Ext
88439
Email
scshun@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiow-Ching Shun, Ph.D
Organizational Affiliation
National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiow-Ching Shun, Ph.D
Phone
886-2-2312-3456
Ext
88439
Email
scshun@ntu.edu.tw
12. IPD Sharing Statement
Learn more about this trial
Development and Validation of Perceived Fatigue Meaning Scale on Walking Program
We'll reach out to this number within 24 hrs