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Gain-framed Messages and NRT for Lung Cancer Screening Patients

Primary Purpose

Lung Cancer Screening, Smoking Cessation

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gain-framed messaging plus NRT
Unframed messaging materials
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer Screening

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 50 years or older
  2. at least a 20-pack year history of smoking
  3. current smoker (defined as any smoking in the past 30 days)
  4. willing to be randomized
  5. English speaking

Exclusion Criteria:

  1. unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia,
  2. known allergy to adhesives
  3. being in the immediate (within 2 weeks) post myocardial infarction period
  4. serious arrhythmias
  5. unstable angina pectoris
  6. hemodynamically or electrically unstable.
  7. current participation in another tobacco treatment program (e.g., using medication from a primary care doctor, Quitline, etc.)

Sites / Locations

  • Yale Cancer Center
  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

No NRT - Unframed Messaging

NRT plus Gain-framed Messaging

Arm Description

Unframed smoking cessation materials, but no NRT and no gain-framed messaging.

Gain-framed messaging plus NRT.

Outcomes

Primary Outcome Measures

Smoking cessation rates
NRT+Gain-framed messaging vs. No NRT+Unframed messaging

Secondary Outcome Measures

Smoking cessation rates
Gain-framed messaging + NRT & Unframed messaging + NRT vs. Gain-framed messaging + No NRT & Unframed messaging + No NRT
Smoking cessation rates
Gain-framed messaging + NRT & Gain-framed messaging + No NRT vs. Unframed messaging + NRT & Unframed messaging + No NRT
Smoking cessation rates
Gain-framed messaging + NRT & Gain-framed messaging + No NRT & Unframed messaging + NRT vs. Unframed messaging + No NRT

Full Information

First Posted
February 28, 2017
Last Updated
September 18, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03069924
Brief Title
Gain-framed Messages and NRT for Lung Cancer Screening Patients
Official Title
Gain-framed Messages and NRT Sampling to Promote Smoking Cessation in Lung Cancer Screening Programs
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
This research is a randomized smoking cessation trial conducted within and specifically personalized for lung cancer screening patients presenting to a lung screening clinic. Novel tobacco treatments for this population are critically needed, given the growing population of lung screening patients, which will grow dramatically now that lung screening is an approved CMS benefit. In the proposed study, we will test a gain-framed messaging intervention specifically designed for lung screening patients (vs. unframed messaging), as well as evaluating NRT sampling (vs. no medication) at 2 study sites. Our project is designed to be translational (in that it can be transferable from our controlled efficacy study to other lung screening programs).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer Screening, Smoking Cessation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
367 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No NRT - Unframed Messaging
Arm Type
Active Comparator
Arm Description
Unframed smoking cessation materials, but no NRT and no gain-framed messaging.
Arm Title
NRT plus Gain-framed Messaging
Arm Type
Experimental
Arm Description
Gain-framed messaging plus NRT.
Intervention Type
Combination Product
Intervention Name(s)
Gain-framed messaging plus NRT
Intervention Description
Gain-framed messaging materials and NRT
Intervention Type
Behavioral
Intervention Name(s)
Unframed messaging materials
Intervention Description
Unframed smoking cessation materials
Primary Outcome Measure Information:
Title
Smoking cessation rates
Description
NRT+Gain-framed messaging vs. No NRT+Unframed messaging
Time Frame
6 month follow-up
Secondary Outcome Measure Information:
Title
Smoking cessation rates
Description
Gain-framed messaging + NRT & Unframed messaging + NRT vs. Gain-framed messaging + No NRT & Unframed messaging + No NRT
Time Frame
6 month follow-up
Title
Smoking cessation rates
Description
Gain-framed messaging + NRT & Gain-framed messaging + No NRT vs. Unframed messaging + NRT & Unframed messaging + No NRT
Time Frame
6 month follow-up
Title
Smoking cessation rates
Description
Gain-framed messaging + NRT & Gain-framed messaging + No NRT & Unframed messaging + NRT vs. Unframed messaging + No NRT
Time Frame
6 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 50 years or older at least a 20-pack year history of smoking current smoker (defined as any smoking in the past 30 days) willing to be randomized English speaking Exclusion Criteria: unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia, known allergy to adhesives being in the immediate (within 2 weeks) post myocardial infarction period serious arrhythmias unstable angina pectoris hemodynamically or electrically unstable. current participation in another tobacco treatment program (e.g., using medication from a primary care doctor, Quitline, etc.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Toll, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alana Rojewski, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Study Director
Facility Information:
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Gain-framed Messages and NRT for Lung Cancer Screening Patients

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