Cancer-related Fatigue During Maintenance Immunotherapy for Non-small Cell Lung Cancer (NSCLC): a Qualitative Study
Recruiting · NCT06567704 · Observational (researchers observe without assigning treatment) · Lead sponsor: Wake Forest University Health Sciences
View the official record on ClinicalTrials.gov →Interventions studied
Interviews
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
2 locations listed across 1 US state.
- Atrium Health Levine Cancer - Charlotte, North Carolina, United States
- Wake Forest Baptist Comprehensive Cancer Center - Winston-Salem, North Carolina, United States