Low Dose Computed Tomography for Lung Cancer Screening

NCT ID: NCT03084835

Last Updated: 2019-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-14

Study Completion Date

2019-04-30

Brief Summary

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This study will evaluate the impact of a proactive, EHR-supported enrollment strategy that links LDCT-eligible smokers with an evidence-based intervention comprised of a web-based program and integrated text messaging. The goal is to provide actionable findings about how to most effectively and cost efficiently promote abstinence in LDCT clinics.

Detailed Description

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Using a 3-arm randomized trial design with repeated measures at 1, 3, 6, and 12 months, the study will randomize N=1650 smokers who present for LDCT lung cancer screening to an passive referral usual care control condition, proactive referral to a digital cessation intervention that combines web and text messaging, or proactive referral to a digital cessation intervention combined with Tobacco Treatment Specialist counseling. The Study will examine overall effectiveness of the interventions in promoting abstinence, the impact of proactive referral to treatment, and the total cost and cost effectiveness of the interventions. The Study will also examine the representativeness of the enrolled sample and explore barriers and facilitators to intervention adoption with LDCT clinic leaders. The trial is structured as a practical clinical trial to answer key questions of direct relevance to LDCT decision-makers.

Conditions

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Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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UC

Usual Care

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

Brief cessation counseling

WEB+TXT

Digital Intervention

Group Type ACTIVE_COMPARATOR

WEB+TXT

Intervention Type BEHAVIORAL

Access to Become an Ex website plus text messaging

WEB+TXT+TTS

Digital plus Counseling Intervention

Group Type ACTIVE_COMPARATOR

WEB+TXT+TTS

Intervention Type BEHAVIORAL

Access to Become an Ex website plus text messaging plus consult with a trained tobacco treatment specialist

Interventions

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Usual Care

Brief cessation counseling

Intervention Type BEHAVIORAL

WEB+TXT

Access to Become an Ex website plus text messaging

Intervention Type BEHAVIORAL

WEB+TXT+TTS

Access to Become an Ex website plus text messaging plus consult with a trained tobacco treatment specialist

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Scheduled for LDCT screening
2. Current smoking (every day/some days)
3. At least weekly use of the Internet
4. Current ownership of cell phone with a text messaging plan
5. Willing to receive study text messages.
6. Ability to complete all aspects of the study
7. Ability to provide signed informed consent

Exclusion Criteria

1. Current (in the past 30 days) use of tobacco cessation medication or participation in tobacco cessation treatment.
2. Those with a condition deemed by the investigators to be exclusionary to the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Truth Initiative

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Ivana Croghan

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James T Hays, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

David E Midthun, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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Graham AL, Burke MV, Jacobs MA, Cha S, Croghan IT, Schroeder DR, Moriarty JP, Borah BJ, Rasmussen DF, Brookover MJ, Suesse DB, Midthun DE, Hays JT. An integrated digital/clinical approach to smoking cessation in lung cancer screening: study protocol for a randomized controlled trial. Trials. 2017 Nov 28;18(1):568. doi: 10.1186/s13063-017-2312-x.

Reference Type BACKGROUND
PMID: 29179734 (View on PubMed)

Burke, MV; Graham, AL; Midthun, DE; Hays, JT; Efficacia delle nuove tecnologie digitali di rete per la smoking cessation nello screening del tumore polmonare (Effectiveness of new digital technologies for smoking cessation in lung cancer screening). Tabaccologia 2019; 2:21-25

Reference Type BACKGROUND

Other Identifiers

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1R01CA207048-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

16-004891

Identifier Type: -

Identifier Source: org_study_id

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