Experiences With and Attitudes Towards Immune Checkpoint Inhibitors in Patients With Non-Small Cell Lung Cancer (NSCLC) - A Single Center, Survey-Based Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Strength of patient perception of Intravenous (IV) Immune Checkpoint Inhibitor (ICI) therapy
研究概览
简要总结
This study evaluates patient satisfaction with receiving intravenous (IV) and/or subcutaneous (SC) immunotherapy and to assess patient preference for IV immunotherapy administration versus SC immunotherapy administration either at the hospital or at home.
详细描述
PRIMARY OBJECTIVES:
I. To assess patient satisfaction with receiving IV immune checkpoint inhibitors, reflecting whether the patient thought that the experience was safe, convenient, comfortable and proceeded smoothly.
II. To assess patient preference for IV versus home SC ICI administration.
OUTLINE: This is an observational study.
Patients complete surveys on study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* Age ≥ 18 years.
- •* Patients must have histopathologically/cytologically confirmed non-small cell lung cancer, currently receiving Atezolizumab, Cemiplimab, Durvalumab, Nivolumab, Pembrolizumab (i.e. the patient has already received at least one cycle of therapy)
- •* Previous chemotherapy/radiotherapy/targeted/immunotherapy is allowed at any prior timepoint.
- •* Ability to understand and the willingness to sign a written informed consent or presence of a surrogate decision maker who can give consent.
排除标准
- •* Patients is unable to consent for themselves
- •* Patient has not yet completed the 1st cycle of ICI-based therapy
研究组 & 干预措施
Observational
Patients complete surveys on study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Strength of patient perception of Intravenous (IV) Immune Checkpoint Inhibitor (ICI) therapy
时间窗: At Baseline through study completion, up to 1 year.
Outcome data will be collected using a questionnaire per study protocol. A Likert scale rating system of Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree will be used. Summaries of data will be descriptive and standard statistical methods (median) will be used to present the results. Pearson's chi-square test, the Mantel-Haenszel test (or corresponding exact tests, if resulting expected numbers are small) will be used; the resulting p-value will be used as an indication of strength of an observed association.
Patient interest in home SC ICI administration vs. IV ICI administration at the infusion center
时间窗: At Baseline through study completion, up to 1 year.
Outcome data will be collected using a questionnaire per study protocol. Results will be summarized with point estimates and confidence intervals; p-values, when calculated, will be used to indicate the strength of an observed association (not just the magnitude).
次要结局
- Strength of patient perception of Subcutaneous (SC) Immune Checkpoint Inhibitor (ICI) therapy.(At Baseline through study completion, up to 1 year.)
- Strength of patient interest in home IV ICI administration vs. SC ICI administration at the infusion center.(At Baseline through study completion, up to 1 year.)
- Transportation and social barriers to obtaining Intravenous (IV) Immune Checkpoint Inhibitor (ICI) therapy.(At Baseline through study completion, up to 1 year.)
- Quality of life while on Immune Checkpoint Inhibitor (ICI) therapy(At Baseline through study completion, up to 1 year.)
- Duration of ICI therapy(Through study completion, up to 1 year.)
- Reason for Discontinuation of ICI therapy.(Through study completion, up to 1 year.)