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Comparing Smoking Cessation Interventions Among Underserved Patients Referred for Lung Cancer Screening

Primary Purpose

Smoking Cessation

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Removal of Financial Barriers

Financial Incentives

Mobile Health Application

About this trial

This is an interventional treatment trial for Smoking Cessation focused on measuring Patients, Underserved, Early Detection of Cancer, Lung Cancer, Nicotine Replacement Products, Incentives, Behavioral Economics, Smoking Cessation, Nicotine Dependence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Current smoker (≥ 1 cigarettes per day, not including e-cigarettes)
Has a low-dose computed tomography (LDCT) scan ordered by their physician
Underserved, defined as one or more of the following: (a) Black, (b) Hispanic, (c) rural residence, or (d) low socioeconomic status (Defined as one or both of: high-school education or less, or household income <200% of the federal poverty line)
Able to receive study invitation and screening, by virtue of showing up to a radiology location affiliated with a participating health system for the LDCT, or having a valid email address or telephone number on file with the health system
Access to a cell phone with text messaging or the internet
Aged 18 years or older

Exclusion Criteria:

No cell phone

Sites / Locations

Kaiser Permanente Southern CaliforniaRecruiting
Henry Ford Health SystemRecruiting
GeisingerRecruiting
University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Arm Label

Basic Usual Care

Enhanced Usual Care

Enhanced Usual Care plus Financial Incentives

Enhanced Usual Care plus Financial Incentives plus Mobile Health Application

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Biochemically confirmed smoking abstinence sustained for 6 months

The primary outcome measure is sustained abstinence for 6 months, and will require self-report of smoking cessation followed by biochemical confirmation at 2 weeks, 3, and 6 months.

Secondary Outcome Measures

Quit status (self-report)

Point-prevalent rates of self-reported nicotine use and tobacco product use

Quit status (biochemically confirmed)

Point-prevalent rates of biochemically confirmed smoking cessation

Health-related quality of life

The EuroQuol Group's quality of life (EQ-5D) scale is a 25-item validated scale used to assess patients' perceived health-related quality of life across the domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

Perceived barriers to cessation

The Challenges to Stopping Smoking Scale (CSS-21) is a validated 21-item measure to assess patients' perceived barriers to smoking cessation. The CSS-21 has two sub-scales: intrinsic factors (physical, psychological or cognitive aspects of quitting) and extrinsic factors (social or environmental aspects of quitting).

Self-efficacy related to cessation efforts

We will use the 10-item situational measure of self-efficacy related to smoking behavior. This scale measures how sure participants are that they can avoid smoking in different situations.

Motivation to quit

The Stages of Change (SOC) is a validated 1-item measure to assess patient's self-reported motivation to quit.

Temporal ("delay") discounting

Temporal discounting is a measure of impulsivity that reflects people's tendencies to discount the value of a reward as a function of how far in the future it would be received. We will use the 5-Trial Adjusting Delay Task to assess temporal discounting.

Full Information

NCT ID

NCT04798664

First Posted

March 11, 2021

Last Updated

October 24, 2022

Sponsor

University of Pennsylvania

Collaborators

Patient-Centered Outcomes Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT04798664

Brief Title

Comparing Smoking Cessation Interventions Among Underserved Patients Referred for Lung Cancer Screening

Official Title

Comparing Smoking Cessation Interventions Among Underserved Patients Referred for Lung Cancer Screening

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 17, 2021 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Pennsylvania

Collaborators

Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To compare the effectiveness of four interventions to promote sustained, biochemically confirmed smoking abstinence for 6 months among underserved smokers referred for lung cancer screening at four large U.S. health systems.

Detailed Description

We will conduct a 4-arm randomized trial comparing 4 interventions to promote sustained, biochemically confirmed smoking abstinence for 6 months among smokers in underserved demographic groups. The 3,200 participants to be enrolled will be current smokers who are Black, Hispanic, and/or have low socioeconomic status (defined as household income <200% of the federal poverty line or a high school education or less) or rural residence who are referred for low-dose computed tomography (LDCT) screening at 4 large health systems. All adult patients with LDCT orders will be further screened for eligibility. Eligible patients will enroll with opt-out consent and complete the study using the NIH-funded Way to Health online research portal. The primary outcome will be biochemically confirmed, sustained abstinence from smoking tobacco for 6 months following participants' selected quit dates. Relapse rates will be tracked at 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Smoking Cessation

Keywords

Patients, Underserved, Early Detection of Cancer, Lung Cancer, Nicotine Replacement Products, Incentives, Behavioral Economics, Smoking Cessation, Nicotine Dependence

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This is a prospective randomized controlled trial using opt-out consent with longitudinal follow-up of patients over 12 months. Based on the expected accrual at each of the four health systems, we expect that overall there will be 470 participants in basic usual care (Arm 1), and 910 participants in each of intervention arms 2-4.

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

3200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Basic Usual Care

Arm Type

No Intervention

Arm Description

Arm Title

Enhanced Usual Care

Arm Type

Active Comparator

Arm Description

Arm Title

Enhanced Usual Care plus Financial Incentives

Arm Type

Active Comparator

Arm Description

Arm Title

Enhanced Usual Care plus Financial Incentives plus Mobile Health Application

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Removal of Financial Barriers

Intervention Description

Free access to nicotine replacement therapies and/or reimbursement for smoking cessation prescription medications

Intervention Type

Behavioral

Intervention Name(s)

Financial Incentives

Intervention Description

Financial incentive plan of up to $600 for biochemically-confirmed, sustained abstinence for 6 months.

Intervention Type

Behavioral

Intervention Name(s)

Mobile Health Application

Intervention Description

Episodic future thinking tool to overcome temporal discounting of future

Primary Outcome Measure Information:

Title

Biochemically confirmed smoking abstinence sustained for 6 months

Description

The primary outcome measure is sustained abstinence for 6 months, and will require self-report of smoking cessation followed by biochemical confirmation at 2 weeks, 3, and 6 months.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Quit status (self-report)

Description

Point-prevalent rates of self-reported nicotine use and tobacco product use

Time Frame

2 weeks, 3 months, 6 months, 12 months

Title

Quit status (biochemically confirmed)

Description

Point-prevalent rates of biochemically confirmed smoking cessation

Time Frame

2 weeks, 3 months, 6 months,12 months

Title

Health-related quality of life

Description

Time Frame

Baseline, 6 months, 12 months

Title

Perceived barriers to cessation

Description

Time Frame

Baseline, 6 months, 12 months

Title

Self-efficacy related to cessation efforts

Description

We will use the 10-item situational measure of self-efficacy related to smoking behavior. This scale measures how sure participants are that they can avoid smoking in different situations.

Time Frame

Baseline, 6 months, 12 months

Title

Motivation to quit

Description

The Stages of Change (SOC) is a validated 1-item measure to assess patient's self-reported motivation to quit.

Time Frame

Baseline, 6 months, 12 months

Title

Temporal ("delay") discounting

Description

Time Frame

Baseline, 6 months, 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Current smoker (≥ 1 cigarettes per day, not including e-cigarettes) Has a low-dose computed tomography (LDCT) scan ordered by their physician Underserved, defined as one or more of the following: (a) Black, (b) Hispanic, (c) rural residence, or (d) low socioeconomic status (Defined as one or both of: high-school education or less, or household income <200% of the federal poverty line) Able to receive study invitation and screening, by virtue of showing up to a radiology location affiliated with a participating health system for the LDCT, or having a valid email address or telephone number on file with the health system Access to a cell phone with text messaging or the internet Aged 18 years or older Exclusion Criteria: No cell phone

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shira Blady, BS

Phone

215-573-3085

bladysh@pennmedicine.upenn.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Vanessa Madden

vmadden@upenn.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott D Halpern, MD PhD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kaiser Permanente Southern California

City

Oakland

State/Province

California

ZIP/Postal Code

94612

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Gould, MD MS

First Name & Middle Initial & Last Name & Degree

Michael Gould, MD MS

First Name & Middle Initial & Last Name & Degree

Mohamed Ismail, MD MPH

Facility Name

Henry Ford Health System

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christine Neslund-Dudas, PhD

First Name & Middle Initial & Last Name & Degree

Christine Neslund-Dudas, PhD

First Name & Middle Initial & Last Name & Degree

Michael Simoff, MD

Facility Name

Geisinger

City

Danville

State/Province

Pennsylvania

ZIP/Postal Code

17822

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Matthew Facktor, MD

First Name & Middle Initial & Last Name & Degree

Matthew Facktor, MD

First Name & Middle Initial & Last Name & Degree

Charlotte Collins, PhD

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Scott D Halpern, MD PhD

First Name & Middle Initial & Last Name & Degree

Scott Halpern, MD PhD

First Name & Middle Initial & Last Name & Degree

Anil Vachani, MD MS

First Name & Middle Initial & Last Name & Degree

Joanna Hart, MD MS

First Name & Middle Initial & Last Name & Degree

Kevin Volpp, MD PhD

First Name & Middle Initial & Last Name & Degree

Rachel Kohn, MD MS

First Name & Middle Initial & Last Name & Degree

Dylan Small, PhD

First Name & Middle Initial & Last Name & Degree

Alisa Stephens-Shields, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Individual participant data that underlie published results will be made available to other researchers, after de-identification.

IPD Sharing Time Frame

Beginning 9 months after publication and up to 36 months following publication. After 36 months the data will be available in our University's data warehouse but without support, except for deposited metadata.

IPD Sharing Access Criteria

Proposals for data use will be reviewed by Principal Investigator and independent review board (such as the Data and Safety Monitoring Board). Approved requestors will need to sign data use agreements to access and use data.

IPD Sharing URL

https://www.pair.upenn.edu

Citations:

PubMed Identifier

34384042

Citation

Kohn R, Vachani A, Small D, Stephens-Shields AJ, Sheu D, Madden VL, Bayes BA, Chowdhury M, Friday S, Kim J, Gould MK, Ismail MH, Creekmur B, Facktor MA, Collins C, Blessing KK, Neslund-Dudas CM, Simoff MJ, Alleman ER, Epstein LH, Horst MA, Scott ME, Volpp KG, Halpern SD, Hart JL; Stakeholder Advisory Committee. Comparing Smoking Cessation Interventions among Underserved Patients Referred for Lung Cancer Screening: A Pragmatic Trial Protocol. Ann Am Thorac Soc. 2022 Feb;19(2):303-314. doi: 10.1513/AnnalsATS.202104-499SD.

Results Reference

derived

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Comparing Smoking Cessation Interventions Among Underserved Patients Referred for Lung Cancer Screening

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