A New Tool for Assessing Fatigue in Individuals With Adva... | NCT00428675

Studies
A New Tool for Assessing Fatigue in Individuals With Advanced Cancer

NCT00428675

Sponsor

University of Alberta

Status

Completed

Last Update Posted

May 18, 2022Actual

Enrollment

228Actual

Phase

Not provided

Conditions

Neoplasms

Interventions

ACI instrument

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Oct 2007Actual

Completion Date

Oct 2010Actual

First Submitted Date

Jan 26, 2007

First Submission Date that Met QC Criteria

Jan 26, 2007

First Posted Date

Jan 30, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2022

Last Update Posted Date

May 18, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

228Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ACI Instrument		228 individuals completed the ACI instrument and other tools	Other: ACI instrument

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ACI score	Adaptive Capacity Index Score	day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Individuals with advanced cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karin L Olson, Ph.D.	University of Alberta	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Nursing, University of Alberta		Edmonton	Alberta	T6G 2T4	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21333991	Result	Olson K, Rogers WT, Cui Y, Cree M, Baracos V, Rust T, Mellott I, Johnson L, Macmillan K, Bonville N. Development and psychometric testing of the Adaptive Capacity Index, an instrument to measure adaptive capacity in individuals with advanced cancer. Int J Nurs Stud. 2011 Aug;48(8):986-94. doi: 10.1016/j.ijnurstu.2011.01.013. Epub 2011 Feb 18.

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D009369	Neoplasms
D005221	Fatigue