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

Recruiting

• Conditions: Non-small Cell Lung Cancer

• 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: 2025-07
• Last Update Submitted: 2025-07-23
• Last Update Posted: 2025-07-28
• Primary Completion: 2026-08-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

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

Inclusion Criteria

Patients:

• ≥ 18 years of age at the time of study entry.

• Must be able to speak, read, and understand English.

• Patients with inoperable NSCLC confirmed by histologic or cytologic documentation and by clinical assessment.

• 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.

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:

• Participants who have received a dose of chemotherapy (including maintenance pemetrexed) within the past 6 months
• Participants who have received radiation therapy within the past 6 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.

Caregivers:

• Cognitively unable to complete interviews.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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