RecruitingObservational

Insomnia in Patients With Metastatic Non Small Cell Lung Cancer

NCT ID: NCT06472804Sponsor: Mayo ClinicLast updated: 2026-02-04

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. Evaluate the frequency of insomnia in patients with metastatic non-small cell lung cancer. OUTLINE: This is an observational study. Patients undergo medical chart review and complete a questionnaire on study.

Arms & interventions

OtherNon-Interventional Study
Non-interventional study

Outcome measures

Primary

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: Baseline

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Recruiting

Clinical Trials Referral Office · Contact

855-776-0015 mayocliniccancerstudies@mayo.edu

Konstantinos Leventakos, M.D., Ph.D. · Principal Investigator