Low Dose Computed Tomography for Lung Cancer Screening

Smoking Clinical Trial

— LDCT  

Official title:

Smoking Cessation in Lung Cancer Screening: Integrated Digital/Clinical Approach

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03084835
• Other study ID #: 16-004891
• Secondary ID: 1R01CA207048-01
• Status: Terminated
• Phase: N/A
• Start date: August 14, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: August 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• Usual Care
Brief cessation counseling
• WEB+TXT
Access to Become an Ex website plus text messaging
• WEB+TXT+TTS
Access to Become an Ex website plus text messaging plus consult with a trained tobacco treatment specialist

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI), Truth Initiative

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	smoking abstinence	biochemically confirmed 12 month smoking abstinence of WEB+TXT;	12 months
Primary	smoking abstinence	biochemically confirmed 12 month smoking abstinence of WEB+TXT+TTS ;	12 months
Primary	smoking abstinence	biochemically confirmed 12 month smoking abstinence of UC;	12 months