Clinical trial · Observational
Cancer-related Fatigue During Maintenance Immunotherapy for Non-small Cell Lung Cancer (NSCLC): a Qualitative Study
NCT06567704CI-TRIAL-00121293recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interviews | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Non-small cell lung cancer (NSCLC)
- description
- Non-small cell lung cancer (NSCLC) patients treated with with immune checkpoint inhibitor.
- interventionNames
- Behavioral: Interviews
Primary outcomes (1)
- measure
- Themes from qualitative interviews with patients
- timeFrame
- At 3 months
- description
- Two semi-structured qualitative interviews will be conducted with 20 patients. Themes will be determined through inductive analysis and will focus on key aspects of symptomatic fatigue, including but not limited to the frequency, duration, and severity of CRF and resulting functional impairments. In addition, history of physical activity before diagnosis, preferences for physical activity to treat CRF, and support needed to adhere to physical activity regimens will be considered. Themes from the first and second interviews will be synthesized to capture changes in fatigue and views on physical activity.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.