Insomnia in Patients With Metastatic Lung Cancer

Recruiting

• Conditions: Stage IV Lung Cancer AJCC v8; Metastatic Lung Non-Small Cell Carcinoma
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06472804
• Lead Sponsor: Mayo Clinic

Brief 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.

Study Timeline

• Study Start: 2019-06-19
• Study First Submitted: 2024-06-19
• Study First Submitted QC: 2024-06-19
• Study First Posted: 2024-06-25
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-03
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional Study	Patients undergo medical chart review and complete a questionnaire on study.

Primary Outcome Measures

Name	Time	Method
Frequency of clinically significant insomnia	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).

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States