Cancer-related Fatigue During Maintenance Immunotherapy for Non-small Cell Lung Cancer (NSCLC): a Qualitative Study
- Conditions
- Non-small Cell Lung Cancer
- Registration Number
- NCT06567704
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria:<br><br>Patients:<br><br> - = 18 years of age at the time of study entry.<br><br> - Patients with inoperable NSCLC confirmed by histologic or cytologic documentation<br> and by clinical assessment.<br><br> - Patients have completed at least two cycles of immune checkpoint inhibitors<br> (adjuvant, unresectable, or advanced metastatic disease) as a monotherapy.<br><br> - If adjuvant or unresectable, immunotherapy must be planned for at least one year.<br><br> - If advanced metastatic NSCLC, immunotherapy must be planned for at least two years.<br><br> - Self-reported cancer or treatment related fatigue as noted in the patient's medical<br> record or per treating physician.<br><br> - Life expectancy of greater than 6 months.<br><br>Caregivers:<br><br> - 18 years of age at the time of study entry.<br><br> - A family member or friend helping a patient with NSCLC would be eligible for this<br> study in any of the following ways as outlined by the National Cancer Institute:<br><br> - Helping with day-to-day activities such as doctor visits or preparing food<br><br> - Giving medicines or helping with physical therapy or other clinical tasks<br><br> - Helping with tasks of daily living such as using the bathroom or bathing<br><br> - Coordinating care and services from a distance by phone or email<br><br> - Giving emotional and spiritual support<br><br>Exclusion Criteria:<br><br>Patients:<br><br> - Patients who are currently receiving or have received chemotherapy and/or radiation<br> within the past 1 year.<br><br> - Diagnosis of dementia.<br><br> - History of clinical depression.<br><br> - Current treatment for sarcopenia and anemia or hemoglobin below 10.<br><br> - Untreated hypothyroidism.<br><br> - Symptomatic heart failure.<br><br> - Oxygen dependent lung disease.<br><br> - Cognitively unable to complete interviews.<br><br>Caregivers:<br><br> - Cognitively unable to complete interviews.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Themes from qualitative interviews with patients
- Secondary Outcome Measures
Name Time Method Severity and impact of cancer-related fatigue (CRF);Themes from qualitative interviews with caregivers;Cancer caregiving tasks, consequences, and needs