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Increasing Lung Cancer Screening Among Emergency Department Patients - LCS R01

28 aprile 2026 aggiornato da: David Adler, University of Rochester

Increasing Lung Cancer Screening Uptake Among Emergency Department Patients - LCS R01

This randomized clinical trial evaluates the effectiveness of text messaging and facilitated referral strategies to increase lung cancer screening uptake among emergency department patients who meet lung cancer screening eligibility criteria.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This randomized clinical trial will evaluate strategies to improve lung cancer screening uptake among emergency department patients who meet lung cancer screening eligibility criteria based on age and smoking history. Participants will be randomized using a 2 by 2 factorial design into one of four groups: basic referral, basic referral plus text messaging, facilitated referral, or facilitated referral plus text messaging.

The basic referral strategy includes verbal referral to the lung cancer screening program and primary care provider, if applicable, along with written contact information for the lung cancer screening program navigator. The facilitated referral strategy includes submission of a lung cancer screening requisition to the lung cancer screening program on behalf of the participant during the emergency department visit.

The text messaging intervention includes a series of theory informed messages designed to increase intention and motivation to complete lung cancer screening. Lung cancer screening uptake will be assessed at 120 days after enrollment using participant follow up and electronic health record review.

Tipo di studio

Interventistico

Iscrizione (Stimato)

1036

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Age 50 - 80
  • ≥ 20 pack-year smoking history
  • current smoker or quit within 15 years
  • English/Spanish speaking
  • Registered in the Emergency Department as a patient

Exclusion Criteria:

  • Non-English/Spanish
  • Inability to provide consent (e.g. high clinical acuity, cognitive deficit)
  • Lack of text-capable mobile phone and/or inability to use text function

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Selezione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione fattoriale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Basic Referral (enhanced control arm)
Participants assigned to this arm will be notified that they are eligible and meet federal recommendations for lung cancer screening. They will be verbally referred to a lung cancer screening program and their primary care provider (if they have one) to discuss lung cancer screening. They will also be provided with written materials that include telephone contact information for the lung cancer screening program navigator. If contacted, the LCS Program Navigator will conduct a discussion, schedule a screening CT scan at one of the 8 regional American College of Radiology-designated lung cancer screening centers and arrange clinical follow-up as needed.
Comportamentale: Basic Referral
Participants are verbally referred to the lung cancer screening program and their primary care provider if applicable. Written materials with contact information for the lung cancer screening program navigator are provided.
Sperimentale: Basic Referral plus Text Messaging
Participants assigned to this arm will receive the basic referral as described in the previous arm. In addition, they will receive a series of text messages, aimed at generating intention and motivation to get lung cancer screening. Patients will receive a total of 9 messages.
Comportamentale: Basic Referral
Participants are verbally referred to the lung cancer screening program and their primary care provider if applicable. Written materials with contact information for the lung cancer screening program navigator are provided.
Comportamentale: Text Messaging
Participants receive a series of up to 9 theory informed text messages designed to increase awareness, motivation, and completion of lung cancer screening.
Comparatore attivo: Facilitated Referral
Participants assigned to this arm will be notified that they are eligible and meet federal recommendations for lung cancer screening. Rather than the basic referral received in the arms above, a lung cancer screening requisition form will be submitted to the lung cancer screening program on behalf of the participant during their emergency department visit.
Comportamentale: Facilitated Referral
A lung cancer screening requisition form is submitted to the lung cancer screening program on behalf of the participant during the emergency department visit. The screening program will contact the participant to discuss screening and schedule a low dose CT scan if appropriate.
Sperimentale: Facilitated Referral plus Text Messaging
Participants assigned to this arm will receive facilitated referral plus the series of text messages described above. Among these participants, contact with the lung cancer screening program is likely to occur after receipt of the initial text messages but prior to receipt of all text messages.
Comportamentale: Text Messaging
Participants receive a series of up to 9 theory informed text messages designed to increase awareness, motivation, and completion of lung cancer screening.
Comportamentale: Facilitated Referral
A lung cancer screening requisition form is submitted to the lung cancer screening program on behalf of the participant during the emergency department visit. The screening program will contact the participant to discuss screening and schedule a low dose CT scan if appropriate.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of Participants Who Complete Lung Cancer Screening Within 120 Days After Enrollment
Lasso di tempo: Up to 120 Days After Enrollment
Lung cancer screening uptake is defined as completion of a low dose computed tomography scan for lung cancer screening within 120 days after enrollment. Screening completion will be confirmed using electronic health record review, lung cancer screening program records, or participant self report obtained during follow up. The outcome is reported as the proportion of participants who complete screening.
Up to 120 Days After Enrollment

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of Participants Who Participate in Shared Decision Making for Lung Cancer Screening Within 120 Days After Enrollment
Lasso di tempo: Up to 120 Days After Enrollment
Participation in shared decision making is defined as documentation of a shared decision making discussion regarding lung cancer screening or participant self report of completing such a discussion within 120 days after enrollment. The outcome is reported as the proportion of participants who participate in shared decision making.
Up to 120 Days After Enrollment
Frequency of Reported Barriers to Lung Cancer Screening at 120 Days
Lasso di tempo: 120 Days After Enrollment
Barriers to lung cancer screening are assessed using participant responses to a structured questionnaire administered at follow up. The questionnaire includes items on transportation challenges, cost concerns, scheduling difficulties, and fear of screening results. The outcome is reported as the number and proportion of participants reporting each barrier.
120 Days After Enrollment
Acceptability of Emergency Department Based Lung Cancer Screening Interventions at 120 Days
Lasso di tempo: Up to 120 Days After Enrollment
Acceptability is assessed using participant responses to Likert scale questionnaire items evaluating the degree to which participants find the emergency department based lung cancer screening interventions acceptable. Each item is scored on a 5 point Likert scale ranging from 1 to 5, with higher scores indicating greater acceptability. The outcome is reported as summary scores based on participant responses.
Up to 120 Days After Enrollment
Appropriateness of Emergency Department Based Lung Cancer Screening Interventions at 120 Days
Lasso di tempo: 120 Days After Enrollment
Appropriateness is assessed using participant responses to Likert scale questionnaire items evaluating the perceived fit and relevance of emergency department based lung cancer screening interventions. Each item is scored on a 5 point Likert scale ranging from 1 to 5, with higher scores indicating greater perceived appropriateness. The outcome is reported as summary scores based on participant responses.
120 Days After Enrollment
Frequency of Reported Facilitators to Lung Cancer Screening at 120 Days
Lasso di tempo: 120 Days After Enrollment
Facilitators to lung cancer screening are assessed using participant responses to a structured questionnaire administered at follow up. The questionnaire includes items related to factors such as access to care, health literacy, prior healthcare engagement, and presence of a primary care provider. The outcome is reported as the number and proportion of participants reporting each facilitator.
120 Days After Enrollment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Rochester

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 marzo 2027

Completamento primario (Stimato)

1 dicembre 2030

Completamento dello studio (Stimato)

1 dicembre 2031

Date di iscrizione allo studio

Primo inviato

27 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 aprile 2026

Primo Inserito (Effettivo)

5 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • FP00007604

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

Undecided

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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