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

Wake Forest University (WFU)

Status: Enrolling

Conditions: Non-small Cell Lung Cancer

Treatments: Behavioral: Interviews

Study type: Observational

Funder types: Other

Identifiers

NCT06567704

ONC-LUN-2401 (Other Identifier)

IRB00116521

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

20 participants in 1 patient group

Non-small cell lung cancer (NSCLC)

Description:

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

Treatment:

Behavioral: Interviews