RecruitingNCT06567704

Cancer-related Fatigue During Maintenance Immunotherapy for Non-small Cell Lung Cancer (NSCLC): a Qualitative Study


Sponsor

Wake Forest University Health Sciences

Enrollment

20 participants

Start Date

Mar 26, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria9

  • ≥ 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 Criteria9

  • 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.

Interventions

BEHAVIORALInterviews

Interviews


Locations(2)

Atrium Health Levine Cancer

Charlotte, North Carolina, United States

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

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NCT06567704


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