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

January 30, 2026 updated by: Wake Forest University Health Sciences
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an observational pilot study. The target population includes adult patients diagnosed with NSCLC receiving an immune checkpoint inhibitor and reporting concerns of fatigue to their provider. This study will be conducted at Levine Cancer Institute (LCI) and Atrium Health Wake Forest Baptist Comprehensive Cancer Center (AHWFBCCC). This study consists of qualitative interviews at two-time points, the primary, and the follow-up. During the primary interview, patients with NSCLC will be asked to complete the PROMIS® Fatigue-Short Form 7a consisting of seven items. During the follow-up interviews, participants will be asked about any change in their fatigue and views on physical activity.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Atrium Health Levine Cancer
        • Principal Investigator:
          • Dori Beeler, PhD
        • Contact:
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest Baptist Comprehensive Cancer Center
        • Principal Investigator:
          • Dori Beeler
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients diagnosed with non-small cell lung cancer (NSCLC) receiving an immune checkpoint inhibitor and reporting concerns of fatigue to their provider.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-small cell lung cancer (NSCLC)
Non-small cell lung cancer (NSCLC) patients treated with with immune checkpoint inhibitor.
Behavioral: Interviews
Interviews

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Themes from qualitative interviews with patients
Time Frame: At 3 months
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.
At 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity and impact of cancer-related fatigue (CRF)
Time Frame: At 3 months
The severity of CRF and its impact on day-to-day function will be measured using the PROMIS® Fatigue-Short Form 7a (F-SF) questionnaire.
At 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

Atrium Health Levine Cancer Institute

Investigators

  • Principal Investigator: Dori Beeler, PhD, Atrium Health Levine Cancer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2025

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

August 20, 2024

First Submitted That Met QC Criteria

August 20, 2024

First Posted (Actual)

August 23, 2024

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00116521
  • ONC-LUN-2401 (Other Identifier: Atrium Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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