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Centralized Care Strategy for Smoking and Lung Cancer Screening

Phase < 1
Recruiting
Led By Robert J Volk
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
30 plus (+) pack-year smoking history
Provide care to adults
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights

Study Summary

This trial studies whether a centralized care strategy, where smokers eligible for lung cancer screening are referred to a dedicated tobacco treatment program, works better in helping people quit smoking and make informed decisions about lung cancer screening compared to usual care.

Who is the study for?
This trial is for current smokers with a history of heavy smoking (30+ pack-years), who are considering lung cancer screening and have an upcoming primary care visit. It's also for health providers caring for such adults. Participants must speak English, but those with a self-reported history of lung cancer cannot join.Check my eligibility
What is being tested?
The study is testing a centralized care strategy to improve quitting smoking and informed decision-making about lung cancer screening. This includes nicotine patches, counseling, questionnaires, quality-of-life assessments, and best practices compared to usual care.See study design
What are the potential side effects?
Potential side effects may include skin irritation from the nicotine patch and emotional or psychological stress during tobacco cessation counseling or from completing questionnaires related to quality of life.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have smoked for 30 or more years.
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I provide care to adults.
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I have smoked for 30 or more years.
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I have a scheduled appointment with my primary care doctor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Lung Cancer Screening 12 items version
Smoking abstinence Questionnairre
Secondary outcome measures
Acceptability, appropriateness, and feasibility of the intervention measure (Weiner et al).
Costs of implementing any smoking cessation plus shared decision making intervention
EuroQoL-5 dimensions
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (centralized care strategy)Experimental Treatment4 Interventions
Participants receive counseling over the phone to help them quit smoking and learn about lung cancer screening over 15-20 minutes for 6-8 sessions over 8 weeks. Participants may also receive nicotine patches.
Group II: Group II (usual care)Active Control3 Interventions
Participants receive counseling on lung cancer screening and smoking cessation from primary care providers at health care visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine Patch
2011
Completed Phase 4
~10480

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,613 Previous Clinical Trials
40,917,785 Total Patients Enrolled
Cancer Prevention Research Institute of TexasOTHER
50 Previous Clinical Trials
97,720 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,797,945 Total Patients Enrolled

Media Library

Tobacco Cessation Counseling Clinical Trial Eligibility Overview. Trial Name: NCT04200534 — Phase < 1
Lung Cancer Research Study Groups: Group II (usual care), Group I (centralized care strategy)
Lung Cancer Clinical Trial 2023: Tobacco Cessation Counseling Highlights & Side Effects. Trial Name: NCT04200534 — Phase < 1
Tobacco Cessation Counseling 2023 Treatment Timeline for Medical Study. Trial Name: NCT04200534 — Phase < 1
Lung Cancer Patient Testimony for trial: Trial Name: NCT04200534 — Phase < 1

Frequently Asked Questions

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

What is the ceiling on participant enrollment for this experiment?

"Affirmative. The information available on clinicaltrials.gov indicates that this study is recruiting at the moment, having been posted in July 2020 and updated last June 2022. A total 520 individuals are sought after among 3 distinct sites."

Answered by AI

Does the research encompass those in their sixties or more advanced years?

"The present trial is limited to those aged between 55 and 77; conversely, there are 52 studies available for minors and 1727 research programs targeting seniors."

Answered by AI

Who meets the qualifications to be involved in this research initiative?

"Eligibility for this trial is restricted to those aged between 55 and 77 with lung cancer. Currently, the clinical study seeks to recruit approximately 520 participants."

Answered by AI

What is the ultimate purpose of this clinical experiment?

"This research project, to be evaluated over a 3-month period, aims to assess smoking abstinence through distribution of the Smoking Abstinence Questionnaire. Secondary goals include gauging the suitability and practicality of the intervention (Weiner et al.) with an 11-item Fidelity Checklist; along with calculating costs associated with personnel, hardware and materials for delivering any shared decision making or smoking cessation interventions."

Answered by AI

Are enrollment opportunities still available for this investigation?

"As of this moment, details on clinicaltrials.gov show that recruitment for this medical trial is still underway. It was first launched back in July 31st 2020 and its most recent update occurred June 23rd 2022."

Answered by AI

Are there any precedent studies that investigated Tobacco Cessation Counseling?

"Presently, there are 71 clinical trials related to Tobacco Cessation Counseling. Of those, 5 studies have reached Phase 3. Most of these reside in Greenville, South carolina; however 204 other locations also offer this form of therapy."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0
What site did they apply to?
University of Texas Health Science Center at Tyler
M D Anderson Cancer Center

Why did patients apply to this trial?

I smoke a pack a day. Because I desperately want to stop smoking. I've tried different things to stop smoking cigarettes nothing has worked so I'm willing to try again.
PatientReceived 1 prior treatment
~113 spots leftby Mar 2025