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Increasing Lung Cancer Screening Among Emergency Department Patients - LCS R01

28. april 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

1036

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Screening
  • Tildeling: Randomisert
  • Intervensjonsmodell: Faktoriell oppgave
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.
Atferdsmessig: 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.
Eksperimentell: 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.
Atferdsmessig: 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.
Atferdsmessig: 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.
Aktiv komparator: 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.
Atferdsmessig: 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.
Eksperimentell: 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.
Atferdsmessig: 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.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of Participants Who Complete Lung Cancer Screening Within 120 Days After Enrollment
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of Participants Who Participate in Shared Decision Making for Lung Cancer Screening Within 120 Days After Enrollment
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Rochester

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. mars 2027

Primær fullføring (Antatt)

1. desember 2030

Studiet fullført (Antatt)

1. desember 2031

Datoer for studieregistrering

Først innsendt

27. april 2026

Først innsendt som oppfylte QC-kriteriene

28. april 2026

Først lagt ut (Faktiske)

5. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • FP00007604

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

Undecided

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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