Insomnia in Patients With Metastatic Lung Cancer

NCT06472804 | Recruiting

• 2 other identifiers: 19-001466NCI-2024-04893
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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).

  Baseline

Study Arms (1)

Observational

Patients undergo medical chart review and complete a questionnaire on study.

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic non small cell lung cancer recruited from Mayo Clinic Oncology Center

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

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

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: June 19, 2019
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)