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NCT06567704 | RECRUITING | Non-small Cell Lung Cancer

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

Condition or disease

Non-small Cell Lung Cancer

Intervention/treatment

Interviews

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 Type : OBSERVATIONAL
Estimated Enrollment : 40 participants
Official Title : Cancer-related Fatigue During Maintenance Immunotherapy for Non-small Cell Lung Cancer (NSCLC): a Qualitative Study
Actual Study Start Date : 2025-03-26
Estimated Primary Completion Date : 2026-08-30
Estimated Study Completion Date : 2026-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Cancer-related Fatigue During Maintenance Immunotherapy for Non-small Cell Lung Cancer (NSCLC): a Qualitative Study

Location Details

NCT06567704

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, North Carolina

Atrium Health Levine Cancer

Charlotte, North Carolina, United States, 28204

RECRUITING

United States, North Carolina

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States, 27157