Symptom Burden and Unmet Supportive Care Needs in Lung Cancer Patients Undergoing First or Second Line Immunotherapy

Study Overview
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Brief Summary
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Doctors are recruiting patients receiving care for lung cancer at the Wake Forest Baptist Comprehensive Cancer Center asking about needs and experiences during immunotherapy. Immunotherapy is a new treatment for lung cancer. The research is to better understand patients' perspectives on what immunotherapy is like and will provide important information to help understand the symptoms patients experience, the impact of treatment on daily life, ways that people adapt to the challenges of treatment, and services that may help people live better during treatment.

Detailed Description
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The overall primary objective of this pilot study is to describe patient-reported symptom burden, unmet supportive care needs, and use of and interest in supportive care services in stage IV non-small cell lung cancer patients undergoing first or second line immunotherapy and to identify psychosocial factors associated with these outcomes. 60 stage IV non-small cell lung cancer patients will be recruited through the Wake Forest Baptist Comprehensive Cancer Center. The study team will use purposive sampling to assure representation of patients at different stages in immunotherapy (i.e., initiating treatment, anticipating scan results, after onset of immune-related side effects).

Official Title
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Symptom Burden and Unmet Supportive Care Needs in Lung Cancer Patients Undergoing First or Second Line Immunotherapy

Conditions
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Lung Neoplasm

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed stage IV (per AJCC 7th edition) non-small cell lung cancer. Receiving first or second line immunotherapy. ECOG Performance status of 0-3. English-speaking Exclusion Criteria: Unable to provide informed consent
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stage IV non-small cell lung cancer<br>60 - stage IV non-small cell lung cancer patients will be recruited through the Wake Forest Baptist Comprehensive Cancer Center to complete the quantitative portion of the study. We will use purposive sampling to assure representation of patients at different stages in immunotherapy (i.e., initiating treatment, anticipating scan results, after onset of immune-related side effects).12-15 of the 60 patients who complete the survey and who express interest in providing feedback on programs and participating in future research will be recruited to complete the qualitative portion of the study | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NCI-PRO-CTCAE items | The NCI-PRO-CTCAE questionnaire will measure patient reported immune-mediated side effect frequency, severity, and interference of selected symptoms on a varied 1-5 scale with lower scales denoting better outcomes. Higher scores reflect greater symptom severity | Past 7 days prior to completion of survey | 
| PROMIS Fatigue | The PROMIS Fatigue questionnaire will measure patient reported fatigue on a varied 1-5 scale with lower scales denoting better outcomes. 8 items responded to on a 1-5 likert type scale, with higher scores reflecting greater fatigue. | Past 7 days prior to completion of survey | 
| EORTC-QLQ-30 questionnaire | EORTC-QLQ-30 questionnaire will measure the patient-reported disease and treatment related symptom severity and interference of 5 functional subscales and 9 symptom subscales. Items are rated on a four-point scale with 1 = not at all to 4 = very much. Subscales are transformed linearly to have a range of 0-100, with higher scores reflecting better function on the 5 functional scales or a higher symptom burden on the symptom scales | Past 7 days prior to completion of survey or 7 days after completion of survey | 
| Functional Assessment of Chronic Illness Therapy - Comprehensive Score for Financial Toxicity (FACIT-COST) | The FACIT-COST will measure patient reported financial toxicity on a 0 (not at all) - 4 (very much) scale with higher scores denoting better outcomes. Scores calculated following the FACIT scoring procedures such that a higher score represents less financial distress. | Past 7 days prior to completion of survey | 
| Supportive Care Needs Survey-Short Form 34 (SCNSF34) questionnaire | The Supportive Care Needs Survey-Short Form 34 questionnaire will measure unmet supportive care needs with a scale of 1 (not applicable) to 5 (high need) with lower score indicating better outcome. Responses are provided on a divided 5-point Likert scale (no unmet need indicated by 1 = not applicable or 2 = satisfied; unmet need indicated by 3 = low need, 4 = moderate need, or 5 = high need). The measure contains 5 domains: health system and information, patient care and support, physical and daily living, psychological, and sexual. | Past 30 days prior to completion of survey | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Short Form Depression | PROMIS Short Form Depression will measure distress on a 1 (never) to 5 (always) scale with lower scores denoting better outcome on a 5-point likert-type scale. Higher scores reflect higher distress. | Past 7 days prior to completion of survey | 
| Prognosis Treatment and Perceptions Questionnaire | Prognosis Treatment and Perceptions Questionnaire will measure the treatment expectations and prognostic understanding using 8 items with varied response options.. | Day 1 of completion of survey | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer, Immunotherapy, Stage IV cancer