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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2010 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01178775
First Posted: August 10, 2010
Last Update Posted: August 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital
  Purpose

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.

Condition Intervention
Gastric Cancer Behavioral: walking

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Fatigue Symptom Inventory [ Time Frame: 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


Estimated Enrollment: 105
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)
Arms Assigned Interventions
No Intervention: 1
control design
No Intervention: 2
education only group
Experimental: 3
education and education and walking program design
Behavioral: walking
use a pedometer for records steps.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patients with gastric cancer during receiving chemotherapy
  • Those who are willing to participate in the research
  • Aged above 18
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01178775


Contacts
Contact: Shiow-Ching Shun, Ph.D 886-2-2312-3456 ext 88439 scshun@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Shiow-Ching Shun, Ph.D    886-2-2312-3456 ext 88439    scshun@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Shiow-Ching Shun, Ph.D National Taiwan University
  More Information

Responsible Party: Shiow-Ching Shun/ Assitant Professor, National Taiwan University
ClinicalTrials.gov Identifier: NCT01178775     History of Changes
Other Study ID Numbers: 200807050R
First Submitted: April 11, 2010
First Posted: August 10, 2010
Last Update Posted: August 10, 2010
Last Verified: August 2010

Keywords provided by National Taiwan University Hospital:
fatigue
meaning
education
walking program

Additional relevant MeSH terms:
Stomach Neoplasms
Fatigue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Signs and Symptoms