Insomnia in Patients With Metastatic Lung Cancer

Mayo Clinic60 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Metastatic Lung Non-Small Cell Carcinoma Stage IV Lung Cancer AJCC v8

Interventions

Non-Interventional StudyOTHER

Non-interventional study

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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