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| ID | Type | Description | Link |
|---|---|---|---|
| ONC-LUN-2401 | Other Identifier | Atrium Health |
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| Name | Class |
|---|---|
| Atrium Health Levine Cancer Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-small cell lung cancer (NSCLC) | Non-small cell lung cancer (NSCLC) patients treated with with immune checkpoint inhibitor. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interviews | Behavioral | Interviews |
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| Measure | Description | Time Frame |
|---|---|---|
| Themes from qualitative interviews with patients | Two semi-structured qualitative interviews will be conducted with 20 patients. Themes will be determined through inductive analysis and will focus on key aspects of symptomatic fatigue, including but not limited to the frequency, duration, and severity of CRF and resulting functional impairments. In addition, history of physical activity before diagnosis, preferences for physical activity to treat CRF, and support needed to adhere to physical activity regimens will be considered. Themes from the first and second interviews will be synthesized to capture changes in fatigue and views on physical activity. | At 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Severity and impact of cancer-related fatigue (CRF) | The severity of CRF and its impact on day-to-day function will be measured using the PROMIS® Fatigue-Short Form 7a (F-SF) questionnaire. | At 3 months |
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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:
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:
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Adult patients diagnosed with non-small cell lung cancer (NSCLC) receiving an immune checkpoint inhibitor and reporting concerns of fatigue to their provider.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megan Lattanze | Contact | (980) 442-4239 | Megan.Lattanze@advocatehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Dori Beeler, PhD | Atrium Health Levine Cancer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Levine Cancer | Recruiting | Charlotte | North Carolina | 28204 | United States |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Wake Forest Baptist Comprehensive Cancer Center | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |