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Trial Radar IA
Lo studio clinico NCT07339254 per Carcinoma polmonare non a piccole cellule è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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Esperienze e attitudini verso gli inibitori dei checkpoint immunitari in pazienti con NSCLC: studio basato su un sondaggio monocentrico 40 Immunoterapia A domicilio

In arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07339254 è uno studio osservazionale per Carcinoma polmonare non a piccole cellule, attualmente in arruolamento. Avviato il 12 marzo 2026, prevede di arruolare 40 partecipanti. Sotto la guida di l'Università della California Meridionale, dovrebbe concludersi entro il 12 marzo 2028. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 16 marzo 2026.
Sommario breve
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.
Descrizione dettagliata
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.

Titolo ufficiale

Experiences With and Attitudes Towards Immune Checkpoint Inhibitors in Patients With Non-Small Cell Lung Cancer (NSCLC) - A Single Center, Survey-Based Study

Patologie
Carcinoma polmonare non a piccole cellule
Altri ID dello studio
Numero NCT
NCT07339254
Data di inizio (effettiva)
2026-03-12
Ultimo aggiornamento pubblicato
2026-03-16
Data di completamento (stimata)
2028-03-12
Arruolamento (previsto)
40
Tipo di studio
Osservazionale
Stato
In arruolamento
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
Observational
Patients complete surveys on study.
Studio non interventistico
Non-interventional study
Esito primario
Misure di esitoDescrizione della misuraArco temporale
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.
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
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.
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.
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
  • * 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.

  • * Patients is unable to consent for themselves
  • * Patient has not yet completed the 1st cycle of ICI-based therapy
University of Southern California logoUniversità della California Meridionale224 studi clinici attivi da esplorare
Nessun dato di contatto
2 Centri dello studio in 1 paesi

California

Los Angeles General Medical Center, Los Angeles, California, 90033, United States
Sandy Tran, Contatto, 323-865-3000, [email protected]
Robert Hsu, Investigatore principale
In arruolamento
USC / Norris Comprehensive Cancer Center, Los Angeles, California, 90033, United States
Sandy Tran, Contatto, 323-865-3000, [email protected]
Robert Hsu, Investigatore principale
In arruolamento