Clinical trial · Observational
Symptom Burden and Unmet Supportive Care Needs in Lung Cancer Patients Undergoing First or Second Line Immunotherapy
- 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)
Doctors are recruiting patients receiving care for lung cancer at the Wake Forest Baptist Comprehensive Cancer Center asking about needs and experiences during immunotherapy. Immunotherapy is a new treatment for lung cancer. The research is to better understand patients' perspectives on what immunotherapy is like and will provide important information to help understand the symptoms patients experience, the impact of treatment on daily life, ways that people adapt to the challenges of treatment, and services that may help people live better during treatment.
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 |
|---|---|---|---|
| Lung Neoplasm | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Stage IV non-small cell lung cancer
- description
- 60 - stage IV non-small cell lung cancer patients will be recruited through the Wake Forest Baptist Comprehensive Cancer Center to complete the quantitative portion of the study. We will use purposive sampling to assure representation of patients at different stages in immunotherapy (i.e., initiating treatment, anticipating scan results, after onset of immune-related side effects).12-15 of the 60 patients who complete the survey and who express interest in providing feedback on programs and participating in future research will be recruited to complete the qualitative portion of the study
Primary outcomes (5)
- measure
- NCI-PRO-CTCAE items
- timeFrame
- Past 7 days prior to completion of survey
- description
- The NCI-PRO-CTCAE questionnaire will measure patient reported immune-mediated side effect frequency, severity, and interference of selected symptoms on a varied 1-5 scale with lower scales denoting better outcomes. Higher scores reflect greater symptom severity
- measure
- PROMIS Fatigue
- timeFrame
- Past 7 days prior to completion of survey
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed stage IV (per AJCC 7th edition) non-small cell lung cancer. * Receiving first or second line immunotherapy. * ECOG Performance status of 0-3. * English-speaking Exclusion Criteria: * Unable to provide informed consent
References
Publications (2)
- RESULTSteffen McLouth LE, Lycan TW Jr, Levine BJ, Gabbard J, Ruiz J, Farris M, Grant SC, Pajewski NM, Weaver KE, Petty WJ. Patient-Reported Outcomes From Patients Receiving Immunotherapy or Chemoimmunotherapy for Metastatic Non-Small-Cell Lung Cancer in Clinical Practice. Clin Lung Cancer. 2020 May;21(3):255-263.e4. doi: 10.1016/j.cllc.2019.11.015. Epub 2019 Nov 29. PMID 31917067
- DERIVEDMcLouth LE, Gabbard J, Levine BJ, Golden SL, Lycan TW, Petty WJ, Weaver KE. Prognostic Awareness, Palliative Care Use, and Barriers to Palliative Care in Patients Undergoing Immunotherapy or Chemo-Immunotherapy for Metastatic Lung Cancer. J Palliat Med. 2023 Jun;26(6):831-836. doi: 10.1089/jpm.2022.0352. Epub 2023 Mar 13. PMID 36912809