NeoplasmsNCT00428675
A New Tool for Assessing Fatigue in Individuals With Advanced Cancer
An observational study of Neoplasms, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- ACI instrument
- How many people
- 228 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2005to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with advanced cancer
Who may be able to join
- 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.
Who cannot join
- Patients unable to give informed consent in English.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Faculty of Nursing, University of Alberta
Edmonton, Alberta, T6G 2T4
About this study
Official title: 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.
Read the 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.
- Conditions
- Neoplasms
- Being tested
- ACI instrument
- Keywords
- screening, fatigue
- Medical subject headings
- Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACI instrumentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ACI Instrument | 228 individuals completed the ACI instrument and other tools Receives: Other: ACI instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACI score
Adaptive Capacity Index Score
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2007 (estimated)
- Study startOct 2005
- Primary completionOct 2007
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karin L Olson, Ph.D., Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428675
- Sponsor's protocol ID
- G118160539
- Status last verified
- Mar 2020
- First submitted
- 26 Jan 2007
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to share data. This was an instrument development study.
Publications
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.
PubMed 21333991
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Rapid Assessment Tool for Fatigue in Palliative Care
- ClinicalTrials.gov ID
- NCT00428675
- Acronym / sponsor ID
- G118160539
- Conditions
- Neoplasms
- Keywords
- screening, fatigue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 30 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACI Instrument | – | Other: ACI instrument228 individuals completed the ACI instrument and other tools |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with advanced cancer
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients unable to give informed consent in English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACI instrumentFollowing 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. | Other | ACI Instrument |
Primary outcome
ACI score
Time frame: day 1
Adaptive Capacity Index Score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Results publication: PubMed 21333991Olson 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.
- Individual participant dataSharing planned: No. No plan to share data. This was an instrument development study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin L Olson, Ph.D. principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACI score (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00428675, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.