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A New Tool for Assessing Fatigue in Individuals With Advanced Cancer

This study is currently recruiting participants.
Verified by University of Alberta, May 2008

Sponsored by: University of Alberta
Information provided by: University of Alberta
ClinicalTrials.gov Identifier: NCT00428675
  Purpose

Fatigue is a common problem in advanced cancer and palliative care. The development of tools to measure fatigue, however, has been slowed by their inability to distinguish between fatigue and other related symptoms, such as tiredness. Our work suggests that these distinctions are important because they serve as markers for stressors associated with advancing disease. We have developed a tool that we believe will distinguish between these two states as well as exhaustion. In this study we will conduct some initial tests of this tool in preparation for its use as an outcome indicator in future studies.


Condition
Neoplasms

MedlinePlus related topics:   Cancer    Palliative Care   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Other, Prospective
Official Title:   Development of a Rapid Assessment Tool for Fatigue in Palliative Care

Further study details as provided by University of Alberta:

Estimated Enrollment:   221
Study Start Date:   October 2005
Estimated Study Completion Date:   March 2009

Detailed Description:

Based on a series of qualitative studies, our group is developing a new rapid fatigue assessment screening tool (rFAST) for use with individuals who have advanced cancer and are receiving care in either an active treatment or palliative setting.

Hypotheses:

  1. The three tools (tiredness, fatigue, and exhaustion) in the rFAST are each defined by the same six dimensions: decline in stamina, decline in cognition, decline in sleep quality, diminished social network, and increased emotional reactivity
  2. The five subscales of the tiredness, fatigue, and exhaustion scales are internally consistent.
  3. Tiredness, fatigue, and exhaustion are distinct states that are manifested by unique patterns of scores on their 6 subscales
  4. The mean POMS-Vsf scores of individuals who meet the definition of fatigue will be lower than the mean POMS-Vsf scores of individuals who meet the definition of tiredness and higher than the mean POMS-Vsf scores of individuals who meet the definition of exhaustion.

Objectives

  1. To examine the factor structure of the tiredness, fatigue, and exhaustion scales of the rFAST.
  2. To examine the internal consistency of the 5 subscales within the tired, fatigue, and exhaustion scales.
  3. To compare actual rFAST scale scores to hypothesized scale profiles for tiredness, fatigue, and exhaustion.
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

Individuals with advanced cancer


Criteria

Inclusion Criteria:

  • Patients with advanced cancer currently receiving treatment for either hematologic or lung cancer at the Jewish General Hospital in Montreal, or patients with advanced cancer currently receiving care through the Alberta Cancer Board (Cross Cancer Institute or Tom Baker Cancer Centre), or the palliative care programs associated with the regional health authority in Edmonton, Alberta who are at least 18 years old, able to read and write English, have a Folstein Mini Mental Status Exam score of at least 22.

Exclusion Criteria:

  • Patients unable to give informed consent in English.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428675

Contacts
Contact: Karin L Olson, Ph.D.     780-492-6403     karin.olson@ualberta.ca    
Contact: Kim Deschamps, MA     780-492-4506     kim.deschamps@ualberta.ca    

Locations
Canada, Alberta
Faculty of Nursing, University of Alberta     Recruiting
      Edmonton, Alberta, Canada, T6G 2T4
      Principal Investigator: Karin L Olson, Ph.D.            

Sponsors and Collaborators
University of Alberta

Investigators
Principal Investigator:     Karin L Olson, Ph.D.     University of Alberta    
  More Information


Responsible Party:   University of Alberta ( Karin Olson )
Study ID Numbers:   G118160539, CIHR# MOP-77798
First Received:   January 26, 2007
Last Updated:   May 13, 2008
ClinicalTrials.gov Identifier:   NCT00428675
Health Authority:   Canada: Canadian Institutes of Health Research

Keywords provided by University of Alberta:
screening  
fatigue  

Study placed in the following topic categories:
Fatigue

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on October 03, 2008




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