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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-09218 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| HS-25-00563 | |||
| 2N-25-8 | Other Identifier | USC / Norris Comprehensive Cancer Center | |
| P30CA014089 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Bristol-Myers Squibb | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Patients complete surveys on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-interventional study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | At Baseline through study completion, up to 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with non-small cell lung cancer, currently receiving Atezolizumab, Cemiplimab, Durvalumab, Nivolumab, or Pembrolizumab.
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| Name | Affiliation | Role |
|---|---|---|
| Robert Hsu | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles General Medical Center | Recruiting | Los Angeles | California | 90033 | United States |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| 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. | At Baseline through study completion, up to 1 year. |
| Transportation and social barriers to obtaining Intravenous (IV) Immune Checkpoint Inhibitor (ICI) therapy. | 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. | At Baseline through study completion, up to 1 year. |
| Quality of life while on Immune Checkpoint Inhibitor (ICI) therapy | 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. | At Baseline through study completion, up to 1 year. |
| Duration of ICI therapy | Collected from the medical record and will be calculated using the start and end dates. | Through study completion, up to 1 year. |
| Reason for Discontinuation of ICI therapy. | Collected from the medical record. | Through study completion, up to 1 year. |
| USC / Norris Comprehensive Cancer Center | Recruiting | Los Angeles | California | 90033 | United States |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |