Lung Cancer ScreeningPhase 2NCT03069924

Gain-framed Messages and NRT for Lung Cancer Screening Patients

A Phase 2 study testing Gain-framed messaging and Unframed messaging materials in people with Lung Cancer Screening and Smoking Cessation, run by Medical University of South Carolina at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for: Lung Cancer Screening, Smoking Cessation
What is being tested?: Gain-framed messaging and Unframed messaging materials
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 367 participants
Where: 2 sitesUnited States
Study dates: 1 Jul 2017to 10 Aug 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

50 years or older
at least a 20-pack year history of smoking
current smoker (defined as any smoking in the past 30 days)
willing to be randomized
English speaking

Who cannot join

unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia,
known allergy to adhesives
being in the immediate (within 2 weeks) post myocardial infarction period
serious arrhythmias
unstable angina pectoris
hemodynamically or electrically unstable.
current participation in another tobacco treatment program (e.g., using medication from a primary care doctor, Quitline, etc.)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Medical University of South Carolina
Charleston, South Carolina, 29425
Yale Cancer Center
New Haven, Connecticut, 06510

Other trials in United States

About this study

Official title: Gain-framed Messages and NRT Sampling to Promote Smoking Cessation in Lung Cancer Screening Programs

This research is a randomized smoking cessation trial conducted within and specifically personalized for lung cancer screening patients presenting to a lung screening clinic. Novel tobacco treatments for this population are critically needed, given the growing population of lung screening patients, which will grow dramatically now that lung screening is an approved CMS benefit. In the proposed study, we will test a gain-framed messaging intervention specifically designed for lung screening patients (vs. unframed messaging), as well as evaluating NRT sampling (vs. no medication) at 2 study sites. Our project is designed to be translational (in that it can be transferable from our controlled efficacy study to other lung screening programs).

Conditions: Lung Cancer Screening, Smoking Cessation
Being tested: Gain-framed messaging, Unframed messaging materials
Medical subject headings: Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Gain-framed messagingBehavioural
Gain-framed messaging materials
Unframed messaging materialsCombination product
Unframed smoking cessation materials

Study groups in NCT03069924
Study group	Role	What they receive
Unframed Messaging	Active comparator	Unframed smoking cessation materials Receives: Combination Product: Unframed messaging materials
Gain-framed Messaging	Experimental	Gain-framed messaging Receives: Behavioral: Gain-framed messaging

What is being measured

The primary outcome is the main question the study is designed to answer.

Smoking Cessation - Available Data
Gain-framed messaging vs. Unframed messaging. 7-day, self-reported abstinence from cigarettes at the 6- month follow-up visit
Measured: 6 month follow-up

Secondary outcomes (2)

Cigarettes Smoked Per Day - Average
Gain-framed messaging vs. Unframed messaging - average reported cigarettes smoked per day.
Measured: 6 month follow-up
Smoking Cessation - Imputed
Gain-framed messaging vs. Unframed messaging. 7-day, self-reported abstinence from cigarettes at the 6- month follow-up visit. Missing participant data imputed to no cessation. 3 participants from the unframed group were not included as they had died prior to the 6-month visit.
Measured: 6 Month Follow up Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 201710 Aug 2024

First posted3 Mar 2017
Study start1 Jul 2017
Primary completion10 Nov 2023
Study completion10 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lung Cancer ScreeningStudies of the same condition, open and under way.
More trials run by Medical University of South CarolinaThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 367 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03069924
Sponsor's protocol ID: Pro00055397
Other IDs: 5R01CA207229-06
Status last verified: Jan 2025
First submitted: 28 Feb 2017
Last updated: 14 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
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Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Active, not recruitingObservational study
Prostate Lung Colorectal and Ovarian (PLCO) Cancer Screening Trial
Cancer, Death

All Lung Cancer Screening trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Gain-framed Messages and NRT Sampling to Promote Smoking Cessation in Lung Cancer Screening Programs
ClinicalTrials.gov ID: NCT03069924
Acronym / sponsor ID: Pro00055397
Conditions: Lung Cancer Screening, Smoking Cessation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 367 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 1 Jul 2017 (actual)
Primary completion: 10 Nov 2023 (actual)
Study completion: 10 Aug 2024 (actual)
First posted: 3 Mar 2017 (actual)
Results: Posted 14 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Unframed Messaging	Active comparator	Combination Product: Unframed messaging materialsUnframed smoking cessation materials
Gain-framed Messaging	Experimental	Behavioral: Gain-framed messagingGain-framed messaging

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

50 years or older
at least a 20-pack year history of smoking
current smoker (defined as any smoking in the past 30 days)
willing to be randomized
English speaking

Key exclusion criteria (7 listed)

unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia,
known allergy to adhesives
being in the immediate (within 2 weeks) post myocardial infarction period
serious arrhythmias
unstable angina pectoris

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
Gain-framed messagingGain-framed messaging materials	Behavioural	Gain-framed Messaging
Unframed messaging materialsUnframed smoking cessation materials	Combination product	Unframed Messaging

Primary outcome

Smoking Cessation - Available Data
Time frame: 6 month follow-up
Gain-framed messaging vs. Unframed messaging. 7-day, self-reported abstinence from cigarettes at the 6- month follow-up visit

2 secondary outcomes

Cigarettes Smoked Per Day - Average
Time frame: 6 month follow-up
Smoking Cessation - Imputed
Time frame: 6 Month Follow up Visit

Results and safety

Results posted to the registry on 14 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Unframed Messaging	183	126
Gain-framed Messaging	184	116

Primary outcome: Smoking Cessation - Available Data

Time frame: 6 month follow-up. Count of participants. Unit: Participants

Measure	Unframed Messaging n = 126	Gain-framed Messaging n = 116
Value	15	19

Population analysed: All available participants are included in the analysis of 7 day point prevalence abstinence at the 6-month follow up visit.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from study entry to the conclusion of the 6-month follow up session or when a participant withdrew from the study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Unframed Messaging	0 of 183 (0%)	0 of 183 (0%)	3 of 183
Gain-framed Messaging	0 of 184 (0%)	0 of 184 (0%)	0 of 184

Limitations and caveats (from the sponsor): Due to low accrual for this clinical trial during the COVID pandemic, we worked with our study statistician and NCI Program Officer to collapse our 4 arm trial to 2 arms. This allowed us to meet our accrual goal and complete the study while still retaining the ability to test our Primary Aim.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Lung Cancer Screening

Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Active, not recruitingObservational study
Prostate Lung Colorectal and Ovarian (PLCO) Cancer Screening Trial
Cancer, Death

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.

Benjamin Toll, PhD principal investigator

Medical University of South Carolina

Alana Rojewski, PhD study director

Medical University of South Carolina

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 7 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: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Cessation - Available Data (time frame: 6 month follow-up). 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 NCT03069924.

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 14 Jan 2025.