Status:
RECRUITING
Cancer-related Fatigue During Maintenance Immunotherapy for Non-small Cell Lung Cancer (NSCLC): a Qualitative Study
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Atrium Health Levine Cancer Institute
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this research is to understand cancer related fatigue in patients with non-small cell lung cancer (NSCLC), who are being treated with an immune checkpoint inhibitor.
Detailed Description
This is an observational pilot study. The target population includes adult patients diagnosed with NSCLC receiving an immune checkpoint inhibitor and reporting concerns of fatigue to their provider. T...
Eligibility Criteria
Inclusion
- ≥ 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
- 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.
Key Trial Info
Start Date :
March 26 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06567704
Start Date
March 26 2025
End Date
December 30 2026
Last Update
December 31 2025
Active Locations (2)
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1
Atrium Health Levine Cancer
Charlotte, North Carolina, United States, 28204
2
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157