- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06350643
Quit and Screen Project
The Quit and Screen Project
The Quit and Screen Project seeks to engage healthcare providers in helping adults who smoke to quit tobacco use, including menthol cigarettes and flavored cigars, and screen for lung cancer early as strategies to reduce multiple chronic diseases.
The goal of this clinical trial is to test the feasibility and impact of the Quit and Screen Project alone versus the G02 (Global Knowledge Center for Lung Cancer) Lung Cancer Screening training + the Quit and Screen Project training modules on changes in provider knowledge, attitudes, and behavioral intentions related to provider advice to quit smoking and referrals for low dose computed tomography among health care providers randomly assigned to each condition. Participants will complete the training modules and complete pre- and post-tests to assess these outcomes.
Study Overview
Status
Conditions
Detailed Description
This clinical trial tests the feasibility and impact of the Quit and Screen Project alone versus the G02 (Global Knowledge Center for Lung Cancer) Lung Cancer Screening training + the Quit and Screen Project training modules on changes in provider knowledge, attitudes, and behavioral intentions related to provider advice to quit smoking and referrals for low dose computed tomography among health care providers randomly assigned to each condition.
In partnership with the National Medical Association, investigators will recruit 300 healthcare providers who provide clinical services to individuals who smoke smoke. Interested providers will be screened; if eligible, the will complete informed consent. Providers who complete the online consent and agree to enroll in the training study will be individually randomized to one of 2 conditions: The Quit and Screen Project alone versus the G02 (Global Knowledge Center for Lung Cancer) Lung Cancer Screening training + the Quit and Screen Project training. After randomization, providers will complete a pre-test assessing their knowledge, attitudes, and behavioral intentions related to provider advice to quit smoking and referrals for low dose computed tomography. Providers will then complete an online training. Providers will then complete a post-test assessing their 1) knowledge, attitudes, and behavioral intentions related to provider advice to quit smoking and referrals for low dose computed tomography and 2) preferences for the online materials and satisfaction with the training. Feasibility will be assessed using data on provider interest in the training and training reach.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mignonne Guy, PhD
- Phone Number: 804-828-1731
- Email: mguy@vcu.edu
Study Contact Backup
- Name: Ashley Clawson, PhD
- Phone Number: 501-526-6413
- Email: aclawson2@uams.edu
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23284
- Virginia Commonwealth Univesity
-
Contact:
- Mignonne Guy, PhD
- Phone Number: 804-828-1731
- Email: mguy@vcu.edu
-
Principal Investigator:
- Mignonne Guy, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Current National Medical Association (NMA) member
- Serves a patient clientele who smokes
- At least 20% of time (1 day per week) devoted to clinical care
- Currently screens clients for tobacco use in the clinic
- Have the capacity to refer smokers to a patient navigator
- Willing to provide informed consent
- Will provide contact email, address and phone.
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Quit and Screen Project training alone
Providers in this arm will only complete the Quit and Screen Project training.
This online course will be developed for healthcare providers and will fill gaps in knowledge and attitudes toward lung cancer screening and smoking not covered by the G02 (Global Knowledge Center for Lung Cancer) Lung Cancer Screening training .
|
This online course will be developed for healthcare providers and will fill gaps in knowledge and attitudes toward lung cancer screening and smoking not covered by the G02 (Global Knowledge Center for Lung Cancer) Lung Cancer Screening training.
|
|
Experimental: Quit and Screen Project training + G02 Lung Cancer Screening training
In this arm, providers will complete the G02 (Global Knowledge Center for Lung Cancer) Lung Cancer Screening training and the Quit and Screen Project training.
The Quit and Screen Project training is an online course being developed to fill gaps in knowledge and attitudes toward lung cancer screening and smoking not covered by the G02 Lung Cancer Screening training.
|
This online course will be developed for healthcare providers and will fill gaps in knowledge and attitudes toward lung cancer screening and smoking not covered by the G02 (Global Knowledge Center for Lung Cancer) Lung Cancer Screening training.
The G02 (Global Knowledge Center for Lung Cancer) Lung Cancer Screening training is an online course that covers disparities in lung cancer and smoking, patient barriers to lung cancer screening, and provider resources for addressing common barriers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Familiarity with treatment guidelines for tobacco and nicotine treatment
Time Frame: This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
|
Familiarity with treatment guidelines was assessed using an modified question from the Healthcare Provider Survey published by Primary Care Development Corporation in 2008.
|
This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
|
|
Weaver et al. 2012 Provider Attitudes and Perceptions about smoking cessation
Time Frame: This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
|
These questions assessed providers perceptions about the benefits of smoking cessation and the benefits of providers advising patients to quit smoking.
|
This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
|
|
Weaver et al. 2012 Provider Perceptions about provider barriers to providing smoking cessation interventions to patients
Time Frame: This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
|
Perceptions about provider barriers to addressing smoking cessation with patient were assessed using modified questions from a questions published in Weaver et al. 2012, Carter-Harris et al. (2017), and Raz et al. 2019.
|
This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
|
|
Provider Perceptions about patient barriers to smoking cessation
Time Frame: This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
|
Perceptions about patient barriers to smoking cessation were assessed using modified questions from a questions published in Weaver et al. 2012, Carter-Harris et al. (2017), and Raz et al. 2019.
|
This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
|
|
Behavioral intentions to screen and advise patients about smoking cessation
Time Frame: This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
|
A set of questions based on the Theory of Planned Behavior assessed provider's intention to screen patients for tobacco use and provide them interventions and referrals for treatment.
|
This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
|
|
Familiarity with lung cancer screening guidelines
Time Frame: This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
|
Familiarity with treatment guidelines was assessed using an modified question from the Healthcare Provider Survey published by Primary Care Development Corporation in 2008.
|
This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
|
|
Knowledge about low dose computed tomography for lung cancer screening
Time Frame: This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
|
Familiarity with treatment guidelines was assessed using an modified question from the questions published by Kota et al. 2022, Carter-Bawa et al. 2022, and the National Cancer Institute National Survey of Primary Care Physicians' Recommendations & Practices for Breast, Cervical, Lung, & Colorectal Cancer Screening.
|
This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
|
|
Perceptions about shared decision-making for low dose computed tomography for lung cancer screening
Time Frame: This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
|
Questions were modified from the questions published by Forcino et al. in 2018.
|
This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
|
|
Perceptions about provider barriers to referring patients to low dose computed tomography for lung cancer screening
Time Frame: This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
|
Questions were modified from questions published by Coughlin et al. 2020.
|
This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
|
|
Provider Perceptions about patient barriers to get screened for lung cancer
Time Frame: This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
|
Perceptions about patient barriers to getting screened for lung cancer were assessed using modified questions from a questions published in Weaver et al. 2012, Carter-Harris et al. (2017), and Raz et al. 2019.
|
This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
|
|
Behavioral intentions to advise patients to get screened for lung cancer via low dose computed tomography
Time Frame: This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
|
A set of questions based on the Theory of Planned Behavior assessed provider's intention to advise patients who smoke to get screened for lung cancer via low dose computed tomography.
|
This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Retention: Percent of providers complete the training after enrolling
Time Frame: This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
|
Study process tracking metrics will be used to assess retention of providers who enroll in the training.
|
This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
|
|
Adherence to completing training modules: Percent of modules completed
Time Frame: This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
|
Study process tracking metrics and training completion data will be used to assess the percent of training modules completed (i.e., the number of modules completed divided by the total available modules).
|
This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
|
|
Preferences regarding training
Time Frame: This is pre-post design. This outcome will be measured during the post-test immediately after they complete the 30-60 minute online training.
|
Questions will assess provider feedback on the online training module.
|
This is pre-post design. This outcome will be measured during the post-test immediately after they complete the 30-60 minute online training.
|
|
Satisfaction with training
Time Frame: This is pre-post design. This outcome will be measured during the post-test immediately after they complete the 30-60 minute online training.
|
Questions will assess provider satisfaction on the online training module.
|
This is pre-post design. This outcome will be measured during the post-test immediately after they complete the 30-60 minute online training.
|
|
Characteristics of enrolled healthcare providers
Time Frame: This is pre-post design. This outcome will be measured during the pre-test immediately before participants complete the 30-60 minute online training.
|
Study process tracking metrics will be used to assess the demographic, training, and clinical practice characteristics of providers who enroll in the training.
|
This is pre-post design. This outcome will be measured during the pre-test immediately before participants complete the 30-60 minute online training.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Pebbles Fagan, PhD, MPH, University of Arkansas
- Principal Investigator: Mignonne Guy, PhD, Virginia Commonwealth University
- Principal Investigator: Ashley Clawson, PhD, University of Arkansas
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 287064
- P50MD017319-03S1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Attitudes
-
Laval UniversityNot yet recruiting
-
University of California, San FranciscoWilliam and Flora Hewlett FoundationCompleted
-
Laval UniversityNot yet recruiting
-
University of California, San FranciscoWilliam and Flora Hewlett FoundationCompleted
-
National Human Genome Research Institute (NHGRI)CompletedGenetics | AttitudesUnited States
-
Mike O'Callaghan Military HospitalActive, not recruiting
-
Pamela HughesActive, not recruitingKnowledge, Attitudes, PracticeUnited States
-
Hacettepe UniversityCompletedKnowledge, Attitudes, PracticeTurkey
-
Ahmad Nassar IbrahimAssiut UniversityUnknownKnowledge, Attitudes, Practice
-
Medical University of LodzCompletedKnowledge, Attitudes, PracticePoland
Clinical Trials on Quit and Screen Project training
-
Kahramanmaras Sutcu Imam UniversityActive, not recruitingParent-Child Relational Problem | Screen Media Use | Problematic Media UseTurkey (Türkiye)
-
University of Colorado, DenverNational Cancer Institute (NCI)Active, not recruitingSmoking | Cigarette SmokingUnited States
-
Duke UniversityNational Institute on Drug Abuse (NIDA); Consumer Wellness SolutionsCompleted
-
Rebecca Norrman and Elin RovaActive, not recruitingStroke | DysphagiaSweden
-
University of Wisconsin, MadisonNational Institute on Drug Abuse (NIDA)CompletedNicotine DependenceUnited States
-
Emory UniversityNational Institute of Mental Health (NIMH); Georgia Department of Public HealthRecruitingAutism | Communication Disorder, ChildhoodUnited States
-
Oregon Research InstituteDrexel UniversityActive, not recruitingOverweight and ObesityUnited States
-
University of RochesterNeuroTrainerActive, not recruiting
-
Johns Hopkins UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedType 2 DiabetesUnited States
-
University of Wisconsin, MadisonCompleted