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Trial Title:
Cancer-related Fatigue During Maintenance Immunotherapy for Non-small Cell Lung Cancer (NSCLC): a Qualitative Study
NCT ID:
NCT06567704
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Fatigue
Conditions: Keywords:
Cancer related fatigue
Immune checkpoint inhibitor
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Behavioral
Intervention name:
Interviews
Description:
Interviews
Arm group label:
Non-small cell lung cancer (NSCLC)
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.
Criteria for eligibility:
Study pop:
Patients with non-small cell lung cancer (NSCLC) receiving an immune checkpoint inhibitor
and report concerns of fatigue to their provider and caregivers.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
Patients:
- ≥ 18 years of age at the time of study entry.
- Patients with inoperable NSCLC confirmed by histologic or cytologic documentation
and by clinical assessment.
- Patients have completed at least two cycles of immune checkpoint inhibitors
(adjuvant, unresectable, or advanced metastatic disease) as a monotherapy.
- If adjuvant or unresectable, immunotherapy must be planned for at least one year.
- If advanced metastatic NSCLC, immunotherapy must be planned for at least two years.
- Self-reported cancer or treatment related fatigue as noted in the patient's medical
record or per treating physician.
- Life expectancy of greater than 6 months.
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:
- Patients who are currently receiving or have received chemotherapy and/or radiation
within the past 1 year.
- Diagnosis of dementia.
- History of clinical depression.
- Current treatment for sarcopenia and anemia or hemoglobin below 10.
- Untreated hypothyroidism.
- Symptomatic heart failure.
- Oxygen dependent lung disease.
- Cognitively unable to complete interviews.
Caregivers:
- Cognitively unable to complete interviews.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Atrium Health Levine Cancer
Address:
City:
Charlotte
Zip:
28204
Country:
United States
Contact:
Last name:
Alicia Patrick
Phone:
980-292-1746
Email:
Alicia.Patrick@atriumhealth.org
Investigator:
Last name:
Dori Beeler
Email:
Principal Investigator
Start date:
October 2024
Completion date:
August 30, 2025
Lead sponsor:
Agency:
Wake Forest University Health Sciences
Agency class:
Other
Collaborator:
Agency:
Atrium Health Levine Cancer Institute
Agency class:
Other
Source:
Wake Forest University Health Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06567704
