Symptom Burden and Unmet Supportive Care Needs in Lung Cancer Patients Undergoing First or Second Line Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- NCI-PRO-CTCAE items
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •English-speaking
排除标准
- •Unable to provide informed consent
结局指标
主要结局
NCI-PRO-CTCAE items
时间窗: Past 7 days prior to completion of survey
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
PROMIS Fatigue
时间窗: Past 7 days prior to completion of survey
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.
EORTC-QLQ-30 questionnaire
时间窗: Past 7 days prior to completion of survey or 7 days after completion of survey
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
Supportive Care Needs Survey-Short Form 34 (SCNSF34) questionnaire
时间窗: Past 30 days prior to completion of survey
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.
Functional Assessment of Chronic Illness Therapy - Comprehensive Score for Financial Toxicity (FACIT-COST)
时间窗: Past 7 days prior to completion of survey
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.
次要结局
- PROMIS Short Form Depression(Past 7 days prior to completion of survey)
- Prognosis Treatment and Perceptions Questionnaire(Day 1 of completion of survey)