Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Patients assigned to the patient navigator (PN) arm will be sent a letter about the program with lung screening educational materials. The PN will educate eligible patients about lung screening, explore barriers to screening, coordinate scheduling an appointment with a provider, and possibly attend the visit with the patient. The PN will further coordinate scheduling the CT scan, help the patient obtain the test, and access any required follow-up. The PN will assess the patient's interest in quitting smoking and if so, offer and help to connect the smoker to existing cessation resources in the community and provide follow-up contacts to monitor adherence to treatments.

The control group will receive usual care during the 1-year study period. After the study period, they will be offered 1:1 patient navigation to obtain lung screening and follow-up of abnormal results as well as smoking cessation guidance.

One to one patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance.

Patient Navigation

Usual care during the study period. After the study period, they will be offered 1:1 patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance.

Usual Care

Sanja Percac-Lima, MD, PhD

To develop and implement a patient navigator (PN) program for lung screening and smoking cessation in community health center primary care practices. This program will be evaluated in a randomized controlled trial of primary care patients who currently smoke.

The specific aims of this study are:

Specific Aim 1: To develop a patient navigator (PN) program for lung screening for patients who are current smokers, aged 55-77 years, potentially eligible for lung screening and are receiving care at community health centers (CHCs) affiliated with MGH.

Specific Aim 2: To evaluate the effectiveness of the new lung screening PN program in improving screening rates and increasing use of tobacco cessation services in a randomized controlled trial.

Specific Aim 3: To demonstrate that equity is maintained in rates of lung screening and in follow up of abnormal chest CT results, comparing eligible smokers from CHCs with eligible smokers from other practices within the MGH primary care network.

Patient Navigation for Lung Screening at MGH Community Health Centers

Percentage of patients assigned to the intervention and control groups who had at least one chest CT (according to billing and EMR data) during the 1-year study period.

Percentage of patients, comparing intervention and control groups, who during the 1-year study period had referral to Massachusetts Quitline, smoking cessation medication prescribed, or referral to in-person counseling.

Massachusetts General Hospital

Assistant Professor

Patients assigned to the patient navigator (PN) arm will be sent a letter about the program with lung screening educational materials. The PN will educate eligible patients about lung screening, explore barriers to screening, coordinate scheduling an appointment with a provider, and possibly attend the visit with the patient. The PN will further coordinate scheduling the CT scan, help the patient obtain the test, and access any required follow-up. The PN will assess the patient's interest in quitting smoking and if so, offer and help to connect the smoker to existing cessation resources in the community and provide follow-up contacts to monitor adherence to treatments.

Patient Navigation: One to one patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance.

The control group will receive usual care during the 1-year study period. After the study period, they will be offered 1:1 patient navigation to obtain lung screening and follow-up of abnormal results as well as smoking cessation guidance.

Usual Care: Usual care during the study period. After the study period, they will be offered 1:1 patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance.

Total

Age, Continuous

Sex: Female, Male

Asian

Black

Hispanic

Other/Unknown

White

Race/Ethnicity, Customized

Language

Insurance

Clinic Visits Over 3 Years

Chest CT Completion

Tobacco Treatment Use

Overall Study

Access to Become an Ex website plus text messaging

WEB+TXT

Access to Become an Ex website plus text messaging plus consult with a trained tobacco treatment specialist

WEB+TXT+TTS

James T Hays, MD

David E Midthun, MD

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.

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.

Low Dose Computed Tomography for Lung Cancer Screening

Smoking Cessation in Lung Cancer Screening: Integrated Digital/Clinical Approach

biochemically confirmed 12 month smoking abstinence of WEB+TXT;

biochemically confirmed 12 month smoking abstinence of WEB+TXT+TTS ;

biochemically confirmed 12 month smoking abstinence of UC;

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Patient Navigation for Lung Screening at MGH Community Health Centers	NCT02705365	Lung Cancer	Patient Navigat... Usual Care	55 Years - 77 Years	Massachusetts General Hospital
Low Dose Computed Tomography for Lung Cancer Screening	NCT03084835	Smoking	Usual Care WEB+TXT WEB+TXT+TTS	18 Years -	Mayo Clinic
Low Dose Computed Tomography for Lung Cancer Screening	NCT03084835	Smoking	Usual Care WEB+TXT WEB+TXT+TTS	18 Years -	Mayo Clinic

Spots Global Cancer Trial Database for lung screening