NCT06567704

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
7mo left

Started Mar 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Mar 2025Dec 2026

First Submitted

Initial submission to the registry

August 20, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

March 26, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

August 20, 2024

Last Update Submit

January 30, 2026

Conditions

Non-small Cell Lung Cancer

Keywords

Cancer related fatigueImmune checkpoint inhibitor

Outcome Measures

Primary Outcomes (1)

  • Themes from qualitative interviews with patients

    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 Outcomes (1)

  • Severity and impact of cancer-related fatigue (CRF)

    At 3 months

Study Arms (1)

Non-small cell lung cancer (NSCLC)

Non-small cell lung cancer (NSCLC) patients treated with with immune checkpoint inhibitor.

Behavioral: Interviews

Interventions

InterviewsBEHAVIORAL

Interviews

Non-small cell lung cancer (NSCLC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • ≥ 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Atrium Health Levine Cancer

Charlotte, North Carolina, 28204, United States

RECRUITING

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Dori Beeler, PhD

    Atrium Health Levine Cancer

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Lattanze

CONTACT

(980) 442-4239Megan.Lattanze@advocatehealth.org

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2024

First Posted

August 23, 2024

Study Start

March 26, 2025

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)