[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06567704":3,"trial-entities:NCT06567704":108,"trial-summary:NCT06567704":112},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":34,"secondary_outcomes":39,"sex":43,"minimum_age":44,"maximum_age":23,"healthy_volunteers":14,"eligibility_criteria":45,"std_ages":67,"locations":70,"central_contacts":102,"overall_officials":104,"references":106,"see_also_links":107},"NCT06567704","IRB00116521","Cancer-related Fatigue During Maintenance Immunotherapy for Non-small Cell Lung Cancer (NSCLC): a Qualitative Study","RECRUITING","2027-07","2026-08","2026-08-10","2025-03-26","Wake Forest University Health Sciences","OTHER",false,"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.",[18],"Non-small Cell Lung Cancer",[20,21],"Cancer related fatigue","Immune checkpoint inhibitor","OBSERVATIONAL",null,[],{"count":26,"type":27},20,"ESTIMATED",[29],{"type":30,"name":31,"description":31,"armGroupLabels":32},"BEHAVIORAL","Interviews",[33],"Non-small cell lung cancer (NSCLC)",[35],{"measure":36,"description":37,"timeFrame":38},"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",[40],{"measure":41,"description":42,"timeFrame":38},"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.","ALL","18 Years",{"inclusion":46,"exclusion":56,"raw_text":66},[47,48,49,50,51,52,53,54,55],"≥ 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\u002Fmetastatic 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.",[57,58,59,60,61,62,63,64,65],"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 \\\u003C10 g\u002FdL.","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.","Inclusion Criteria:\n\n* ≥ 18 years of age at the time of consent.\n* Must be able to speak, read, and understand English.\n* Participants diagnosed with NSCLC, and:\n\n  * have advanced\u002Fmetastatic disease who are currently receiving immunotherapy monotherapy, or\n  * have locally advanced disease who are currently receiving immunotherapy monotherapy after completing thoracic radiation therapy, or\n  * who underwent resection and are currently receiving immunotherapy monotherapy after completing all other perioperative treatment\n* 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)\n* Have completed at least two cycles of immunotherapy.\n* Self-reported cancer-related fatigued that impacts daily function.\n\nExclusion Criteria:\n\n* Participants who have received a dose of chemotherapy (including maintenance pemetrexed) within the past 3 months\n* 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.\n* Diagnosis of dementia.\n* Anemia Hgb \\\u003C10 g\u002FdL.\n* Sarcopenia which is being pharmacologically treated with a prescribed appetite stimulant (e.g., megestrol).\n* Untreated hypothyroidism.\n* Symptomatic heart failure.\n* Oxygen dependent lung disease.\n* Cognitively unable to complete interviews per investigator.",[68,69],"ADULT","OLDER_ADULT",[71,89],{"facility":72,"status":7,"city":73,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":86},"Atrium Health Levine Cancer","Charlotte","North Carolina","28204","United States",[78,83],{"name":79,"role":80,"phone":81,"email":82},"Megan Lattanze","CONTACT","(980) 442-4239","Megan.Lattanze@advocatehealth.org",{"name":84,"role":85},"Dori Beeler, PhD","PRINCIPAL_INVESTIGATOR",{"lat":87,"lon":88},35.22709,-80.84313,{"facility":90,"status":7,"city":91,"state":74,"zip":92,"country":76,"contacts":93,"geoPoint":99},"Wake Forest Baptist Comprehensive Cancer Center","Winston-Salem","27157",[94,97],{"name":84,"role":80,"phone":95,"email":96},"980-442-7883","Dori.Beeler@advocatehealth.org",{"name":98,"role":85},"Dori Beeler",{"lat":100,"lon":101},36.09986,-80.24422,[103],{"name":79,"role":80,"phone":81,"email":82},[105],{"name":84,"affiliation":72,"role":85},[],[],{"nct_id":4,"conditions":109,"biomarkers":111},[110],"Lung Non-Small Cell Carcinoma",[],{"nct_id":4,"found":113,"summary":114,"prompt_version":124},true,{"design":115,"status":116,"heading":117,"summary":118,"follow_up":119,"word_count":120,"commitments":121,"compensation":122,"drugs_mentioned":123},"This is an observational study involving about 20 participants. It is not testing a new treatment but rather observing and understanding experiences.","completed","Understanding Cancer-Related Fatigue in NSCLC Patients on Immunotherapy","This observational study aims to understand cancer-related fatigue in people with non-small cell lung cancer (NSCLC) who are receiving immunotherapy, specifically checkpoint inhibitors. Researchers will conduct interviews with about 20 participants to learn about their experiences with fatigue. You might be able to join if you are at least 18 years old, speak English, have NSCLC, and are currently receiving immunotherapy. The study will look for common themes in what patients say about their fatigue, with initial findings expected around 3 months into the study. The current recruitment status is unclear.","Your fatigue will be measured at 3 months, and you will have a follow-up interview to discuss changes in your fatigue and views on physical activity.",91,"You would participate in two interviews, one primary and one follow-up. During the primary interview, you will also complete a short questionnaire about your fatigue.","Not stated in the trial record.",[31],"v2"]