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

NCT ID: NCT06567704

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-26

Study Completion Date

2026-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Non-small Cell Lung Cancer

Keywords

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Cancer related fatigue Immune checkpoint inhibitor

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-small cell lung cancer (NSCLC)

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

Interviews

Intervention Type BEHAVIORAL

Interviews

Interventions

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Interviews

Interviews

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Atrium Health Levine Cancer Institute

OTHER

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dori Beeler, PhD

Role: PRINCIPAL_INVESTIGATOR

Atrium Health Levine Cancer

Locations

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Atrium Health Levine Cancer

Charlotte, North Carolina, United States

Site Status RECRUITING

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Megan Lattanze

Role: CONTACT

Phone: (980) 442-4239

Email: [email protected]

Facility Contacts

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Megan Lattanze

Role: primary

Dori Beeler, PhD

Role: primary

Other Identifiers

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ONC-LUN-2401

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00116521

Identifier Type: -

Identifier Source: org_study_id