NCT03084835

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

August 14, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

August 29, 2019

Status Verified

August 1, 2019

Enrollment Period

1.7 years

First QC Date

March 9, 2017

Last Update Submit

August 27, 2019

Conditions

Smoking

Keywords

tobaccosmokinglow dose computed tomographylung screeningtext messaging

Outcome Measures

Primary Outcomes (3)

  • smoking abstinence

    biochemically confirmed 12 month smoking abstinence of WEB+TXT;

    12 months

  • smoking abstinence

    biochemically confirmed 12 month smoking abstinence of WEB+TXT+TTS ;

    12 months

  • smoking abstinence

    biochemically confirmed 12 month smoking abstinence of UC;

    12 months

Study Arms (3)

UC

ACTIVE COMPARATOR

Usual Care

Behavioral: Usual Care

WEB+TXT

ACTIVE COMPARATOR

Digital Intervention

Behavioral: WEB+TXT

WEB+TXT+TTS

ACTIVE COMPARATOR

Digital plus Counseling Intervention

Behavioral: WEB+TXT+TTS

Interventions

Usual CareBEHAVIORAL

Brief cessation counseling

UC
WEB+TXTBEHAVIORAL

Access to Become an Ex website plus text messaging

WEB+TXT
WEB+TXT+TTSBEHAVIORAL

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

WEB+TXT+TTS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Current (in the past 30 days) use of tobacco cessation medication or participation in tobacco cessation treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

  • 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.

    PMID: 29179734BACKGROUND

  • 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

    BACKGROUND

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • James T Hays, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • David E Midthun, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

March 9, 2017

First Posted

March 21, 2017

Study Start

August 14, 2017

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

August 29, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)