- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00428675
A New Tool for Assessing Fatigue in Individuals With Advanced Cancer
May 12, 2022 updated by: University of Alberta
Development of a Rapid Assessment Tool for Fatigue in Palliative Care
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.
Study Overview
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:
- 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.
Study Type
Observational
Enrollment (Actual)
228
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6G 2T4
- Faculty of Nursing, University of Alberta
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Individuals with advanced cancer
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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ACI Instrument
228 individuals completed the ACI instrument and other tools
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ACI score
Time Frame: day 1
|
Adaptive Capacity Index Score
|
day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Karin L Olson, Ph.D., University of Alberta
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
October 1, 2007
Study Completion (Actual)
October 1, 2010
Study Registration Dates
First Submitted
January 26, 2007
First Submitted That Met QC Criteria
January 26, 2007
First Posted (Estimate)
January 30, 2007
Study Record Updates
Last Update Posted (Actual)
May 18, 2022
Last Update Submitted That Met QC Criteria
May 12, 2022
Last Verified
March 1, 2020
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No plan to share data.
This was an instrument development study.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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