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NCT Number: NCT06472804

Insomnia in Patients With Metastatic Lung Cancer

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.

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Key information

Conditions

Metastatic Lung Non-Small Cell Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Stage IV Lung Cancer AJCC v8 Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Konstantinos Leventakos, M.D., Ph.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Primary outcomes

  1. Frequency of clinically significant insomnia

    Time frame: Baseline

    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).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Insomnia in Patients With Metastatic Non Small Cell Lung Cancer

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Jun 25, 2024
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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