Cancer-related Fatigue During Maintenance Immunotherapy for Non-small Cell Lung Cancer (NSCLC): a Qualitative Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Interviews.
- Who it may be relevant to
- Registry conditions: Non-small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 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.
Interventions
- Behavioral Interviews
Interviews
Primary outcome measures
- Themes from qualitative interviews with patients [Time frame: At 3 months]
Secondary outcome measures (1)
- Severity and impact of cancer-related fatigue (CRF) [Time frame: At 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 2 centers
- Atrium Health Levine Cancer — Charlotte
- Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem
Identifiers
NCT: NCT06567704 · IRB00116521 · ONC-LUN-2401