Insomnia in Patients With Metastatic Lung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
This study evaluates how common insomnia (difficulties with sleep) is in patients with lung cancer that has spread from where it first started (primary site) to other places in the body.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have a diagnosis of metastatic non small cell lung cancer
Undergoing 1st, 2nd or 3rd line of treatment or are in maintenance therapy
Older than 18 years old at the time of diagnosis
Disqualifiers
Subjects will be excluded if they are considered to have advanced terminal cancer, severe depression or other psychiatric disorder or a sleep disorder other than insomnia (sleep apnea, restless leg syndrome, sleep related disorder of breathing), regular use of psychotropic medication other than hypnotics (eg antidepressants) per chart review
Trial population
Patients with metastatic non small cell lung cancer recruited from Mayo Clinic Oncology Center
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Non-Interventional Study
Other interventionNon-interventional study
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Observational1 intervention
Trial outcomes
Primary outcomes
1
Frequency of clinically significant insomnia
Will be assessed using the Insomnia Severity Index questionnaire (ISI), is a 7-item self-report questionnaire used to gauge the perceived severity of difficulties initiating sleep, staying asleep, and early morning awakenings, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. ISI score of 15 or greater will be used to categorize clinical insomnia. 0 - 7: no clinically significant insomnia, 8 - 14: subthreshold insomnia, 15 - 21: clinical insomnia (moderate severity), 22 - 28: clinical insomnia (severe).
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov