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Increasing Lung Cancer Screening Among Emergency Department Patients - LCS R01

28. dubna 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

1036

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Promítání
  • Přidělení: Randomizované
  • Intervenční model: Faktorové přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: 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.
Behaviorální: 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.
Experimentální: 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.
Behaviorální: 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.
Behaviorální: 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.
Aktivní komparátor: 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.
Behaviorální: 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.
Experimentální: 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.
Behaviorální: 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.
Behaviorální: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Proportion of Participants Who Complete Lung Cancer Screening Within 120 Days After Enrollment
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Proportion of Participants Who Participate in Shared Decision Making for Lung Cancer Screening Within 120 Days After Enrollment
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Rochester

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. března 2027

Primární dokončení (Odhadovaný)

1. prosince 2030

Dokončení studie (Odhadovaný)

1. prosince 2031

Termíny zápisu do studia

První předloženo

27. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

28. dubna 2026

První zveřejněno (Aktuální)

5. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

5. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

28. dubna 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • FP00007604

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NEROZHODNÝ

Popis plánu IPD

Undecided

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

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