A New Tool for Assessing Fatigue in Individuals With Advanced Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karin Olson, University of Alberta
ClinicalTrials.gov Identifier:
NCT00428675
First received: January 26, 2007
Last updated: November 29, 2011
Last verified: November 2011
  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

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

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Enrollment: 221
Study Start Date: October 2005
Study Completion Date: October 2010
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
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
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, see Learn About Clinical Studies.

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

Locations
Canada, Alberta
Faculty of Nursing, University of Alberta
Edmonton, Alberta, Canada, T6G 2T4
Sponsors and Collaborators
Karin Olson
Investigators
Principal Investigator: Karin L Olson, Ph.D. University of Alberta
  More Information

No publications provided

Responsible Party: Karin Olson, Professor, Nursing, University of Alberta
ClinicalTrials.gov Identifier: NCT00428675     History of Changes
Other Study ID Numbers: G118160539, CIHR# MOP-77798
Study First Received: January 26, 2007
Last Updated: November 29, 2011
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by University of Alberta:
screening
fatigue

Additional relevant MeSH terms:
Neoplasms
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014