Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-28 @ 3:20 PM
Study NCT ID:
NCT06567704
Status:
RECRUITING
Last Update Posted:
2025-07-28
First Post:
2024-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cancer-related Fatigue During Maintenance Immunotherapy for Non-small Cell Lung Cancer (NSCLC): a Qualitative Study
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
Cancer-related Fatigue During Maintenance Immunotherapy for Non-small Cell Lung Cancer (NSCLC): a Qualitative Study
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ONC-LUN-2401 | OTHER | Atrium Health | View |