Lung Non-Small Cell Carcinoma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERNon-Interventional Study
Non-interventional study
Sponsors
University of Southern California
National Cancer Institute (NCI)
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient interest in home SC ICI administration vs. IV ICI administration at the infusion center | 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). |
| Strength of patient perception of Intravenous (IV) Immune Checkpoint Inhibitor (ICI) therapy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| Transportation and social barriers to obtaining Intravenous (IV) Immune Checkpoint Inhibitor (ICI) therapy. | At Baseline through study completion, up to 1 year. | Outcome data will be collected using a questionnaire consisting of 7 questions. The proportion of participants who select each possible category will be reported. The proportions should add up to 1.0. Results will be summarized in 2-way contingency tables to display any associations between these transportation responses. The Mantel-Haenszel test will be used to estimate the strength of the associations in each contingency table. |
| Quality of life while on Immune Checkpoint Inhibitor (ICI) therapy | At Baseline through study completion, up to 1 year. | Patient-Reported Outcomes Measurement Information System (PROMIS-29 v2.1) will be used. This is a standardized, self-report questionnaire with 29 items measuring core health areas like physical function, pain (interference \& intensity), anxiety, depression, fatigue, sleep, and social participation, providing T-scores (mean 50, SD 10) for consistent comparison, used to capture patient-reported quality of life. |
| Reason for Discontinuation of ICI therapy. | Through study completion, up to 1 year. | Collected from the medical record. |
| Duration of ICI therapy | Through study completion, up to 1 year. | Collected from the medical record and will be calculated using the start and end dates. |
| Strength of patient perception of Subcutaneous (SC) Immune Checkpoint Inhibitor (ICI) therapy. | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRobert Hsu
University of Southern California
Outcome results
None listed