Understanding cancer-related fatigue in lung cancer patients on immunotherapy
Cancer-related Fatigue During Maintenance Immunotherapy for Non-small Cell Lung Cancer (NSCLC): a Qualitative Study
This study is trying to understand how cancer-related fatigue affects people with lung cancer who are receiving immunotherapy and what their caregivers experience during this time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 2 sites (Charlotte, North Carolina and 1 other locations) |
| Trial ID | NCT06567704 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with inoperable NSCLC who have completed at least two cycles of immune checkpoint inhibitors and report fatigue.
Not a fit: Patients with operable NSCLC or those who have not received immune checkpoint inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into managing fatigue in lung cancer patients, potentially improving their quality of life.
How similar studies have performed: While there have been studies on cancer-related fatigue, this specific qualitative approach in the context of NSCLC and immunotherapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Charlotte, North Carolina and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.