Clinical trial NCT06567704: Cancer-related Fatigue During Maintenance Immunotherapy for Non-small Cell Lung Cancer (NSCLC): a Qualitative Study
Official title: Cancer-related Fatigue During Maintenance Immunotherapy for Non-small Cell Lung Cancer (NSCLC): a Qualitative Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-small Cell Lung Cancer
Keywords: Cancer related fatigue
Immune checkpoint inhibitor
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Atrium Health Levine Cancer Institute
First posted: 2024-08-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-small cell lung cancer (NSCLC) receiving an immune checkpoint inhibitor and report concerns of fatigue to their provider and caregivers.

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.

Eligibility 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.

Primary outcomes:
measure: Themes from qualitative interviews with patients
timeFrame: At 3 months
Secondary outcomes:
measure: Severity and impact of cancer-related fatigue (CRF)
timeFrame: At 3 months
measure: Themes from qualitative interviews with caregivers
timeFrame: At 3 months
measure: Cancer caregiving tasks, consequences, and needs
timeFrame: At 3 months
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Atrium Health Levine Cancer
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Atrium Health Levine Cancer
name: Dori Beeler
role: PRINCIPAL_INVESTIGATOR
References: