Advanced CancerNCT00450541
Fatigue Experience in Cancer Patients
An observational study of Advanced Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to learn what it is like when a patient with cancer has fatigue, as well as how these patients define fatigue. Researchers want to use this information to create questionnaires that may more accurately measure fatigue and its effects in patients with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Questionnaire and Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Apr 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: Patients with cancer that may be experiencing fatigue.
Who may be able to join
- 18 years of age or older
- Ability to speak and read English
- Diagnosis of cancer, currently receiving treatment, receiving supportive care, or surviving after treatment
- Self report of current experience of fatigue
- Consent to participate
- Patient from M. D. Anderson Cancer Center inpatient unit or outpatient clinic
Who cannot join
- Inability to understand the intent of the study
- Medical condition that would preclude participation in an interview session lasting 40 minutes
- Diagnosis of active psychosis or severe cognitive impairment confirmed by the patient's attending physician.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: The Experience of Fatigue for Patients With Cancer
The goal of this research study is to learn what it is like when a patient with cancer has fatigue, as well as how these patients define fatigue. Researchers want to use this information to create questionnaires that may more accurately measure fatigue and its effects in patients with cancer.
Read the detailed description
STUDY PARTICIPATION:
If you agree to take part in this study, you will be interviewed by a member of the study staff and then asked to complete a series of questionnaires and verbal (spoken) questions.
During the interview, you will be asked to describe what fatigue means to you and what it is like for you to have fatigue. The interview will take place while you are at M. D. Anderson receiving your routine care. You will be interviewed alone, and the information gathered during the interview will be kept strictly confidential. The interview will take about 30 minutes to complete. It will be audiotaped so that participants' responses can be fully analyzed.
You will then be asked to complete 4 questionnaires and answer 2 separate questions.
The first questionnaire will include questions about your personal identifying information (such as your age and marital status).
You will then be asked 1 question about your quality of life and another question about how well you are performing day-to-day activities.
You will then be asked to complete a second questionnaire in which you will rate your fatigue level and how fatigue interferes with your daily activities.
You will be asked to complete a third questionnaire about your opinion of the fatigue questionnaire (the second questionnaire). For example, you will be asked if the fatigue questionnaire was easy to understand and to complete. Learning your opinion about this questionnaire will help researchers learn what important questions may be missing from the questionnaire.
Finally, you will then be asked to complete a questionnaire that asks you to rate the severity of a list of 13 symptoms and how much these symptoms interfere with some of your daily activities.
The questionnaires and additional questions should take a total of 15-20 minutes to complete.
After you have completed the interview and questionnaires, a research assistant will review your electronic medical record to collect information about your disease and treatments.
LENGTH OF STUDY:
Your participation in this study will be over after you complete the interview, the questionnaires, and the additional questions.
This is an investigational study. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Advanced Cancer
- Being tested
- Questionnaire, Interview
- Keywords
- Advanced Cancer, Fatigue, Interview, Questionnaire, Survey
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Four questionnaires taking 15-20 minutes total to complete.
InterviewBehavioural
Interview lasting about 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Fatigue Questionnaire + Interview | Not described Receives: Behavioral: Questionnaire; Behavioral: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of Cancer Patient Fatigue Experiences (Questionnaire + Interview Responses)
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cephalon
- Responsible party
- Sponsor
- Investigators
- Loretta A. Williams, DSN, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00450541
- Sponsor's protocol ID
- 2007-0004
- Status last verified
- Jul 2012
- First submitted
- 20 Mar 2007
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Experience of Fatigue for Patients With Cancer
- ClinicalTrials.gov ID
- NCT00450541
- Acronym / sponsor ID
- 2007-0004
- Conditions
- Advanced Cancer
- Keywords
- Advanced Cancer, Fatigue, Interview, Questionnaire, Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Cephalon
- Study start
- Mar 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 22 Mar 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.
The goal of this research study is to learn what it is like when a patient with cancer has fatigue, as well as how these patients define fatigue. Researchers want to use this information to create questionnaires that may more accurately measure fatigue and its effects in patients with cancer.
Detailed description
STUDY PARTICIPATION:
If you agree to take part in this study, you will be interviewed by a member of the study staff and then asked to complete a series of questionnaires and verbal (spoken) questions.
During the interview, you will be asked to describe what fatigue means to you and what it is like for you to have fatigue. The interview will take place while you are at M. D. Anderson receiving your routine care. You will be interviewed alone, and the information gathered during the interview will be kept strictly confidential. The interview will take about 30 minutes to complete. It will be audiotaped so that participants' responses can be fully analyzed.
You will then be asked to complete 4 questionnaires and answer 2 separate questions.
The first questionnaire will include questions about your personal identifying information (such as your age and marital status).
You will then be asked 1 question about your quality of life and another question about how well you are performing day-to-day activities.
You will then be asked to complete a second questionnaire in which you will rate your fatigue level and how fatigue interferes with your daily activities.
You will be asked to complete a third questionnaire about your opinion of the fatigue questionnaire (the second questionnaire). For example, you will be asked if the fatigue questionnaire was easy to understand and to complete. Learning your opinion about this questionnaire will help researchers learn what important questions may be missing from the questionnaire.
Finally, you will then be asked to complete a questionnaire that asks you to rate the severity of a list of 13 symptoms and how much these symptoms interfere with some of your daily activities.
The questionnaires and additional questions should take a total of 15-20 minutes to complete.
After you have completed the interview and questionnaires, a research assistant will review your electronic medical record to collect information about your disease and treatments.
LENGTH OF STUDY:
Your participation in this study will be over after you complete the interview, the questionnaires, and the additional questions.
This is an investigational study. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fatigue Questionnaire + Interview | – | Behavioral: Questionnaire, Behavioral: Interview |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cancer that may be experiencing fatigue.
Key inclusion criteria (6 listed)
- 18 years of age or older
- Ability to speak and read English
- Diagnosis of cancer, currently receiving treatment, receiving supportive care, or surviving after treatment
- Self report of current experience of fatigue
- Consent to participate
Key exclusion criteria (3 listed)
- Inability to understand the intent of the study
- Medical condition that would preclude participation in an interview session lasting 40 minutes
- Diagnosis of active psychosis or severe cognitive impairment confirmed by the patient's attending physician.
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 |
|---|---|---|
| QuestionnaireAlso: SurveyFour questionnaires taking 15-20 minutes total to complete. | Behavioural | Fatigue Questionnaire + Interview |
| InterviewInterview lasting about 30 minutes. | Behavioural | Fatigue Questionnaire + Interview |
Primary outcome
Description of Cancer Patient Fatigue Experiences (Questionnaire + Interview Responses)
Time frame: 2 Years
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 30 Jul 2012.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Loretta A. Williams, DSN principal investigator
M.D. Anderson Cancer Center
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 Advanced Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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 6 inclusion and 3 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 30 Jul 2012. 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 United States. 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?
Description of Cancer Patient Fatigue Experiences (Questionnaire + Interview Responses) (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2012; AzTrials last refreshed its copy on 6 Nov 2026.