SmokingLDCTNCT03084835
Low Dose Computed Tomography for Lung Cancer Screening
A study testing WEB+TXT and WEB+TXT+TTS in people with Smoking, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- WEB+TXT and WEB+TXT+TTS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2017to 30 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current (in the past 30 days) use of tobacco cessation medication or participation in tobacco cessation treatment.
- Those with a condition deemed by the investigators to be exclusionary to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smoking Cessation in Lung Cancer Screening: Integrated Digital/Clinical Approach
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.
Read the detailed 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.
- Conditions
- Smoking
- Being tested
- Usual Care, WEB+TXT, WEB+TXT+TTS
- Keywords
- tobacco, smoking, low dose computed tomography, lung screening, text messaging
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareBehavioural
Brief cessation counseling
WEB+TXTBehavioural
Access to Become an Ex website plus text messaging
WEB+TXT+TTSBehavioural
Access to Become an Ex website plus text messaging plus consult with a trained tobacco treatment specialist
| Study group | Role | What they receive |
|---|---|---|
| UC | Active comparator | Usual Care Receives: Behavioral: Usual Care |
| WEB+TXT | Active comparator | Digital Intervention Receives: Behavioral: WEB+TXT |
| WEB+TXT+TTS | Active comparator | Digital plus Counseling Intervention Receives: Behavioral: WEB+TXT+TTS |
What is being measured
The primary outcome is the main question the study is designed to answer.
smoking abstinence
biochemically confirmed 12 month smoking abstinence of WEB+TXT;
Measured: 12 months
smoking abstinence
biochemically confirmed 12 month smoking abstinence of WEB+TXT+TTS ;
Measured: 12 months
smoking abstinence
biochemically confirmed 12 month smoking abstinence of UC;
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start14 Aug 2017
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Why it stopped: Low Study Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Truth Initiative
- Responsible party
- Principal investigator, Ivana Croghan, Mayo Clinic
- Investigators
- James T Hays, MD, Principal investigator, Mayo ClinicDavid E Midthun, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084835
- Sponsor's protocol ID
- 16-004891
- Other IDs
- 1R01CA207048-01
- Acronym
- LDCT
- Status last verified
- Aug 2019
- First submitted
- 9 Mar 2017
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29179734Burke, 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation in Lung Cancer Screening: Integrated Digital/Clinical Approach
- ClinicalTrials.gov ID
- NCT03084835
- Acronym / sponsor ID
- LDCT / 16-004891
- Conditions
- Smoking
- Keywords
- tobacco, smoking, low dose computed tomography, lung screening, text messaging
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Study Accrual
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Truth Initiative
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 21 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| UC | Active comparator | Behavioral: Usual CareUsual Care |
| WEB+TXT | Active comparator | Behavioral: WEB+TXTDigital Intervention |
| WEB+TXT+TTS | Active comparator | Behavioral: WEB+TXT+TTSDigital plus Counseling Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- Current (in the past 30 days) use of tobacco cessation medication or participation in tobacco cessation treatment.
- Those with a condition deemed by the investigators to be exclusionary to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual CareBrief cessation counseling | Behavioural | UC |
| WEB+TXTAccess to Become an Ex website plus text messaging | Behavioural | WEB+TXT |
| WEB+TXT+TTSAccess to Become an Ex website plus text messaging plus consult with a trained tobacco treatment specialist | Behavioural | WEB+TXT+TTS |
Primary outcome
smoking abstinence
Time frame: 12 months
biochemically confirmed 12 month smoking abstinence of WEB+TXT;
smoking abstinence
Time frame: 12 months
biochemically confirmed 12 month smoking abstinence of WEB+TXT+TTS ;
smoking abstinence
Time frame: 12 months
biochemically confirmed 12 month smoking abstinence of UC;
Results and safety
The study was stopped early (reason given: Low Study Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- Background: PubMed 29179734Graham 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.
- BackgroundBurke, 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James T Hays, MD principal investigator
Mayo Clinic
David E Midthun, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WEB+TXT and WEB+TXT+TTS in people with Smoking, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low Study Accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
smoking abstinence (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03084835, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2019.