Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT06567704
Eligibility Criteria:
Inclusion Criteria:
Patients:
* ≥ 18 years of age at the time of study entry.
* Must be able to speak, read, and understand English.
* Patients with inoperable NSCLC confirmed by histologic or cytologic documentation and by clinical assessment.
* 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.
Caregivers:
* 18 years of age at the time of study entry.
* A family member or friend helping a patient with NSCLC would be eligible for this study in any of the following ways as outlined by the National Cancer Institute:
* Helping with day-to-day activities such as doctor visits or preparing food
* Giving medicines or helping with physical therapy or other clinical tasks
* Helping with tasks of daily living such as using the bathroom or bathing
* Coordinating care and services from a distance by phone or email
* Giving emotional and spiritual support
Exclusion Criteria:
Patients:
* Participants who have received a dose of chemotherapy (including maintenance pemetrexed) within the past 6 months
* Participants who have received radiation therapy within the past 6 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.
Caregivers:
\- Cognitively unable to complete interviews.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06567704
Study Brief:
Protocol Section:
NCT06567704