Understanding cancer-related fatigue in lung cancer patients on immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational pilot study aims to explore the experiences of cancer-related fatigue in patients with inoperable non-small cell lung cancer (NSCLC) undergoing treatment with immune checkpoint inhibitors. The study involves qualitative interviews conducted at two time points, where patients will complete a fatigue assessment and caregivers will provide insights into their caregiving experiences. Participants will be asked about changes in fatigue and their views on physical activity during follow-up interviews. The research is being conducted at Levine Cancer Institute and Atrium Health Wake Forest Baptist Comprehensive Cancer Center.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ≥ 18 years of age at the time of consent.
* Must be able to speak, read, and understand English.
* Participants diagnosed with NSCLC, and:

  * have advanced/metastatic disease who are currently receiving immunotherapy monotherapy, or
  * have locally advanced disease who are currently receiving immunotherapy monotherapy after completing thoracic radiation therapy, or
  * who underwent resection and are currently receiving immunotherapy monotherapy after completing all other perioperative treatment
* Immunotherapy planned to continue for at least three months after the time of study enrollment (to ensure participant remains on IO long enough to obtain study assessments)
* Have completed at least two cycles of immunotherapy.
* Self-reported cancer-related fatigued that impacts daily function.

Exclusion Criteria:

* Participants who have received a dose of chemotherapy (including maintenance pemetrexed) within the past 3 months
* Participants who have received radiation therapy within the past 3 months. Note: a short course of palliative radiation therapy within up to 20 Gy and up to 5 fractions is permissible.
* Diagnosis of dementia.
* Anemia Hgb \<10 g/dL.
* Sarcopenia which is being pharmacologically treated with a prescribed appetite stimulant (e.g., megestrol).
* Untreated hypothyroidism.
* Symptomatic heart failure.
* Oxygen dependent lung disease.
* Cognitively unable to complete interviews per investigator.

Where it's running

• Atrium Health Levine Cancer
  Charlotte, North Carolina, United States Recruiting
• Wake Forest Baptist Comprehensive Cancer Center
  Winston-Salem, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Dori Beeler, PhD — Atrium Health Levine Cancer
• Study coordinator: Megan Lattanze
• Email: Megan.Lattanze@advocatehealth.org
• Phone: (980) 442-4239

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.