Lung CancerNCT00187980
Sleep Disturbance in Lung Cancer Patients.
An observational study of Lung Cancer, run by University Hospital, Angers at 1 site in France.
Trial summary
The aim of this study is to 1-evaluate subjectively by questionnaires and objectively by ambulatory actigraphy the quality of sleep in patients with newly diagnosed lung cancer; 2- to correlate sleep quality index with quality of life, daytime alertness, Performans status and lung cancer staging at diagnosis. Read more about this study
- Who is it for?
- Ages 18 months and older, women only
- Conditions the study is for
- Lung Cancer
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2005to not given
- 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 months and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Newly diagnosed lung cancer age > 18 yrs Performans status < 3 Informed consent Life expectancy > 5 months
Who cannot join
- Psychiatric disease Performans status > 2 Known sleep disorder
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
UH
Angers, 49033 cedex
Yannick Le Guen, MD, 33(0)241355844, yaleguen@chu-angers.fr
About this study
The aim of this study is to 1-evaluate subjectively by questionnaires and objectively by ambulatory actigraphy the quality of sleep in patients with newly diagnosed lung cancer; 2- to correlate sleep quality index with quality of life, daytime alertness, Performans status and lung cancer staging at diagnosis.
- Conditions
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Investigators
- Yannick Le Guen, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00187980
- Sponsor's protocol ID
- CP 05-02
- Status last verified
- Sep 2005
- First submitted
- 9 Sep 2005
- Last updated
- 16 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disturbance in Lung Cancer Patients.
- ClinicalTrials.gov ID
- NCT00187980
- Acronym / sponsor ID
- CP 05-02
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jun 2005
- First posted
- 16 Sep 2005 (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 aim of this study is to 1-evaluate subjectively by questionnaires and objectively by ambulatory actigraphy the quality of sleep in patients with newly diagnosed lung cancer; 2- to correlate sleep quality index with quality of life, daytime alertness, Performans status and lung cancer staging at diagnosis.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 months and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Newly diagnosed lung cancer age > 18 yrs Performans status < 3 Informed consent Life expectancy > 5 months
Key exclusion criteria (1 listed)
- Psychiatric disease Performans status > 2 Known sleep disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2005.
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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.
Yannick Le Guen principal investigator
University Hospital, Angers
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 Lung Cancer, run by University Hospital, Angers at 1 site in France.
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: status not confirmed, as of the sponsor's last update on 16 Sep 2005. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yannick Le Guen, MD (33(0)241355844, yaleguen@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 16 Sep 2005.