A New Tool for Assessing Fatigue in Individuals With Advanced Cancer

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.

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Key information

Conditions

Neoplasms Fatigue Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Nursing, University of Alberta

Edmonton, Alberta, T6G 2T4, Canada

About this study

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:

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
The five subscales of the tiredness, fatigue, and exhaustion scales are internally consistent.
Tiredness, fatigue, and exhaustion are distinct states that are manifested by unique patterns of scores on their 6 subscales
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

To examine the factor structure of the tiredness, fatigue, and exhaustion scales of the rFAST.
To examine the internal consistency of the 5 subscales within the tired, fatigue, and exhaustion scales.
To compare actual rFAST scale scores to hypothesized scale profiles for tiredness, fatigue, and exhaustion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ACI instrument

Other

Following ethics approval, 17 experts in symptom management assisted with content validation during the pilot phase. In the main study, participants complete the FACT-F, the POMS-Vsf, and the ACI Instrument. A research assistant collected demographic information and assigned an ECOG score.

Primary outcomes

ACI score

Time frame: day 1

Adaptive Capacity Index Score

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

Development of a Rapid Assessment Tool for Fatigue in Palliative Care

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2010
First posted: Jan 30, 2007
Registry last updated: May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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