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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

Be older than 18 years old

Must not have

History of lung cancer by self-report

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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

Select...

I have smoked for 30 or more years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with lung cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Lung Cancer Screening 12 items version

Smoking abstinence Questionnairre

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 2Eligibility criteria met