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

Recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Behavioral: Interviews

• Registration Number: NCT06567704
• Lead Sponsor: Wake Forest University Health Sciences

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.

Detailed Description

This is an observational pilot study. The target population includes non-dyad caregivers and adult patients diagnosed with inoperable NSCLC receiving an immune checkpoint inhibitor and report concerns of fatigue to their provider and caregivers. 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 and caregivers will be asked to complete the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN) form consisting of 5-items in the caregiving workload subscale. During the follow-up interviews, participants will be asked about any change in their fatigue and views on physical activity.

Study Timeline

• Study First Submitted: 2024-08-20
• Study First Submitted QC: 2024-08-20
• Study First Posted: 2024-08-23
• Study Start: 2025-03-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02
• Primary Completion: 2025-08-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Patients:

• ≥ 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.

Caregivers:

• 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

Exclusion Criteria

Patients:

• 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.

Caregivers:

• Cognitively unable to complete interviews.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Themes from qualitative interviews with patients	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.

Secondary Outcome Measures

Name	Time	Method
Severity and impact of cancer-related fatigue (CRF)	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.
Themes from qualitative interviews with caregivers	At 3 months	Two semi-structured qualitative interviews will be conducted with 20 caregivers. Themes will be determined through inductive analysis and will focus on the caregiver perspective of CRF severity and functional impacts on the patient. In addition, the role caregivers play in CRF treatments will be explored. Themes from the first and second interviews will be synthesized to capture changes in caregiver perspectives on fatigue and views on physical activity.
Cancer caregiving tasks, consequences, and needs	At 3 months	The extent of cancer caregivers' perceptions of tasks, consequences, and needs will be assessed using the Cancer Caregiving Tasks, Consequences, and Needs Questionnaire (CaTCoN).

Trial Locations

Locations (2)

Atrium Health Levine Cancer; 🇺🇸 Charlotte, North Carolina, United States

Wake Forest Baptist Comprehensive Cancer Center; 🇺🇸 Winston-Salem, North Carolina, United States