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Smoking Cessation Interventions for Lung Cancer Screening Patients

N/A

Recruiting

Led By Scott D Halpern, MD PhD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has a low-dose computed tomography (LDCT) scan ordered by their physician

Aged 18 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks, 3 months, 6 months,12 months

Awards & highlights

Study Summary

This trial will compare the effectiveness of four interventions to help smokers quit smoking for at least six months.

Who is the study for?

This trial is for underserved adult smokers referred for lung cancer screening. Participants must be 18+, have a cell phone with text or internet, and meet at least one of these: Black, Hispanic, rural resident, or low income. They should smoke at least 1 cigarette per day and not use e-cigarettes.Check my eligibility

What is being tested?

The study compares four ways to help people quit smoking: removing cost barriers to quitting aids, offering money rewards for staying smoke-free, using a mobile app designed to support quitting efforts. The goal is to see which method helps maintain no smoking for six months.See study design

What are the potential side effects?

There may not be direct medical side effects from the interventions since they involve financial incentives and digital tools rather than medications. However, participants might experience stress or frustration related to trying to quit smoking.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My doctor has ordered a low-dose CT scan for me.

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I am 18 years old or older.

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I smoke at least one cigarette a day.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks, 3 months, 6 months,12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks, 3 months, 6 months,12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks, 3 months, 6 months,12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Biochemically confirmed smoking abstinence sustained for 6 months

Secondary outcome measures

Health-related quality of life

Motivation to quit

Perceived barriers to cessation

+4 more

Trial Design

4Treatment groups

Active Control

Group I: Enhanced Usual Care plus Financial Incentives plus Mobile Health ApplicationActive Control3 Interventions

Participants receive all aspects of Arm 3 plus an intervention to promote episodic future thinking (EFT), called FutureMe. EFT has been shown to reliably reduce discounting of the future. Patients will practice using EFT cues to envision the "future is now" between the time of enrollment and the quit date, and will then receive cues from the quit date through the end of the intervention period, 6 months later, unless they ask to stop receiving cues sooner.

Group II: Enhanced Usual Care plus Financial IncentivesActive Control2 Interventions

Participants receive all aspects of enhanced usual care plus an incentive plan in which they will be informed of their eligibility to earn $100, $200, and $300 if they submit negative tests for nicotine metabolites at 2 weeks, 3 month and 6 months following their quit date, respectively.

Group III: Basic Usual CareActive Control1 Intervention

Participants receive the usual care approach, Ask-Advise-Refer (AAR), which is a standard approach in which non-study clinicians ask smokers about their desire to quit smoking, advise them to quit, and provide informational resources such as hotlines, specialized clinics, or smoking cessation classes.

Group IV: Enhanced Usual CareActive Control1 Intervention

Participants receive the basic usual care of Ask-Advise-Refer as well as free access to nicotine replacement therapy (NRT) and/or reimbursement of up to $300 for any smoking cessation medications (varenicline/Chantix or bupropion/Zyban) prescribed by non-study clinicians.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,005 Previous Clinical Trials

42,879,009 Total Patients Enrolled

Patient-Centered Outcomes Research InstituteOTHER

551 Previous Clinical Trials

29,994,258 Total Patients Enrolled

Scott D Halpern, MD PhDPrincipal InvestigatorUniversity of Pennsylvania

1 Previous Clinical Trials

1,917 Total Patients Enrolled

Media Library

Enhanced Usual Care plus Financial Incentives plus Mobile Health Application Clinical Trial Eligibility Overview. Trial Name: NCT04798664 — N/A

Smoking Cessation Research Study Groups: Enhanced Usual Care plus Financial Incentives plus Mobile Health Application, Enhanced Usual Care plus Financial Incentives, Basic Usual Care, Enhanced Usual Care

Smoking Cessation Clinical Trial 2023: Enhanced Usual Care plus Financial Incentives plus Mobile Health Application Highlights & Side Effects. Trial Name: NCT04798664 — N/A

Enhanced Usual Care plus Financial Incentives plus Mobile Health Application 2023 Treatment Timeline for Medical Study. Trial Name: NCT04798664 — N/A

Smoking Cessation Patient Testimony for trial: Trial Name: NCT04798664 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is the trial population involved in this research?

"To successfully complete this clinical trial, a total of 3200 participants are required to meet the prerequisites. Notably, Kaiser Permanente Southern California in Oakland and Henry Ford Health System in Detroit have both opened their doors for recruitment."

Answered by AI

How many healthcare institutions are administering this clinical trial?

"This clinical trial is available at Kaiser Permanente Southern California in Oakland, Henry Ford Health System in Detroit, and University of Pennsylvania in Philadelphia. There are 4 other locations offering this study as well."

Answered by AI

Are there still openings available for the participants of this clinical trial?

"Indeed, the information from clinicaltrials.gov reveals this investigation is still in search of participants. The trial was launched on May 17th 2021 and has been updated as recently as October 24th 2022. 3200 individuals have to be enrolled across 4 sites for completion of the study."

Answered by AI

Who else is applying?

What state do they live in?

Michigan

Pennsylvania

How old are they?

18 - 65

What site did they apply to?

Kaiser Permanente Southern California

Henry Ford Health System

University of Pennsylvania

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I have lung nodules that leave me with only 40 percent of lung capacity I was going to the pulmonary specialist every 6 months to see if they mastasized. I have chronic bronchitis and I have smoked since I was 14. A pack a pay. Menthol.

PatientReceived 1 prior treatment