Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00428675
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2007-01-26
Brief Title:
A New Tool for Assessing Fatigue in Individuals With Advanced Cancer
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
Development of a Rapid Assessment Tool for Fatigue in Palliative Care
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None