NCT07339254 - Experiences w/ & Attitudes Towards Immune Chckpt Inhibitors in NSCLC Patients Single Center Survey Based Study | Crick

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

40

Conditions

Lung Non-Small Cell Carcinoma

Interventions

Non-Interventional StudyOTHER

Non-interventional study

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * \* 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. Exclusion Criteria: * \* Patients is unable to consent for themselves * \* Patient has not yet completed the 1st cycle of ICI-based therapy

Locations (2)

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

Strength of patient perception of Intravenous (IV) Immune Checkpoint Inhibitor (ICI) therapy

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.

Time frame: At Baseline through study completion, up to 1 year.

Patient interest in home SC ICI administration vs. IV ICI administration at the infusion center

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).

Time frame: At Baseline through study completion, up to 1 year.

Secondary Outcomes

Strength of patient perception of Subcutaneous (SC) Immune Checkpoint Inhibitor (ICI) therapy.

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.

Time frame: 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.

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.