RECRUITING

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

Conditions

Non-small Cell Lung Cancer Cancer related fatigue Immune checkpoint inhibitor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02

Study Completion:2025-08-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06567704

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* ≥ 18 years of age at the time of study entry. * Patients with inoperable NSCLC confirmed by histologic or cytologic documentation and by clinical assessment. * Patients have completed at least two cycles of immune checkpoint inhibitors (adjuvant, unresectable, or advanced metastatic disease) as a monotherapy. * If adjuvant or unresectable, immunotherapy must be planned for at least one year. * If advanced metastatic NSCLC, immunotherapy must be planned for at least two years. * Self-reported cancer or treatment related fatigue as noted in the patient's medical record or per treating physician. * Life expectancy of greater than 6 months. * 18 years of age at the time of study entry. * A family member or friend helping a patient with NSCLC would be eligible for this study in any of the following ways as outlined by the National Cancer Institute: * Helping with day-to-day activities such as doctor visits or preparing food * Giving medicines or helping with physical therapy or other clinical tasks * Helping with tasks of daily living such as using the bathroom or bathing * Coordinating care and services from a distance by phone or email * Giving emotional and spiritual support	* Patients who are currently receiving or have received chemotherapy and/or radiation within the past 1 year. * Diagnosis of dementia. * History of clinical depression. * Current treatment for sarcopenia and anemia or hemoglobin below 10. * Untreated hypothyroidism. * Symptomatic heart failure. * Oxygen dependent lung disease. * Cognitively unable to complete interviews.

Inclusion Criteria

Exclusion Criteria

* ≥ 18 years of age at the time of study entry.
* Patients with inoperable NSCLC confirmed by histologic or cytologic documentation and by clinical assessment.
* Patients have completed at least two cycles of immune checkpoint inhibitors (adjuvant, unresectable, or advanced metastatic disease) as a monotherapy.
* If adjuvant or unresectable, immunotherapy must be planned for at least one year.
* If advanced metastatic NSCLC, immunotherapy must be planned for at least two years.
* Self-reported cancer or treatment related fatigue as noted in the patient's medical record or per treating physician.
* Life expectancy of greater than 6 months.
* 18 years of age at the time of study entry.
* A family member or friend helping a patient with NSCLC would be eligible for this study in any of the following ways as outlined by the National Cancer Institute:
* Helping with day-to-day activities such as doctor visits or preparing food
* Giving medicines or helping with physical therapy or other clinical tasks
* Helping with tasks of daily living such as using the bathroom or bathing
* Coordinating care and services from a distance by phone or email
* Giving emotional and spiritual support

* Patients who are currently receiving or have received chemotherapy and/or radiation within the past 1 year.
* Diagnosis of dementia.
* History of clinical depression.
* Current treatment for sarcopenia and anemia or hemoglobin below 10.
* Untreated hypothyroidism.
* Symptomatic heart failure.
* Oxygen dependent lung disease.
* Cognitively unable to complete interviews.

Contacts and Locations

Study Contact

Alicia Patrick

CONTACT

(980) 292-1746

Alicia.Patrick@atriumhealth.org

Principal Investigator

Dori Beeler

PRINCIPAL_INVESTIGATOR

Atrium Health Levine Cancer

Study Locations (Sites)

Atrium Health Levine Cancer

Charlotte, North Carolina, 28204

United States

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Dori Beeler, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2025-02

Study Completion Date2025-08-30

Study Record Updates

Study Start Date2025-02

Study Completion Date2025-08-30

Terms related to this study

Keywords Provided by Researchers

Cancer related fatigue
Immune checkpoint inhibitor

Additional Relevant MeSH Terms

Non-small Cell Lung Cancer