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Implementation of Smoking Cessation Within NCI Community Oncology Research Program (NCORP) Sites (OaSiS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03291587
Recruitment Status : Completed
First Posted : September 25, 2017
Results First Posted : July 25, 2022
Last Update Posted : July 25, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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Brief Summary:
Evaluate a multi-faceted training program to improve short-term smoking cessation rates (<14 days post-visit) and short (3 months) and sustained abstinence (6 months) among 1,114 enrolled smokers who present for low-dose computed tomography (LDCT) lung cancer screening in 26 community-based practices.

Condition or disease Intervention/treatment Phase
Smoking Cessation Other: Personnel Training and Coaching Calls Not Applicable

Detailed Description:
We utilize an effectiveness-implementation hybrid design, employing a cluster, randomized control trial of community-based NCORP sites to study the effectiveness of a multi-faceted intervention to improve smoking cessation among lung cancer screening patients, as well as dissemination and implementation (D&I) science to optimize and accelerate translation of findings into clinical practice. We will: (1) Evaluate a multi-faceted training program to improve short-term smoking cessation rates (1-week post-visit) and sustained abstinence (6 months) among 1,114 enrolled smokers (557 in each trial arm) who present for LDCT lung cancer screening in community-based lung cancer screening practices; (2) Characterize the adoption and adaptation of the evidence-based tobacco cessation strategies in 26 community-based LDCT lung cancer screening programs; and (3) Develop and evaluate an implementation toolkit for integrating evidence-based tobacco cessation strategies in community-based LDCT lung cancer screening programs. Qualitative data will be collected from key informants at participating screening programs during and after intervention implementation. Quantitative survey data (baseline, <14 days, 3 months, and 6 months) and saliva specimens (6 months only) will be collected from smoking patients receiving screening within these programs.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1094 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Implementation Of Smoking Cessation Services Within NCI NCORP Community Sites With Organized Lung Cancer Screening Programs
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : February 22, 2021
Actual Study Completion Date : February 22, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention

Training of Lung Cancer Screening Personnel on implementation of the United States Public Health Service (US PHS) Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study

Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, <14 days, 3 months, and 6 months)

 Other: Personnel Training and Coaching Calls

Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study

Each site will have a coaching team: two members of our research team including an expert in tobacco cessation and an expert in lung cancer screening. Active coaching includes six, 1-1 ½ hour video exchanges among program sites and coaching teams, once every 4-6 weeks over an 8-month implementation phase. One week prior to the call, each site will be prompted with an email to inform the coaching team of any challenges associated with implementation.
No Intervention: Usual Care

No training or performance coaching calls on personnel, just usual clinic practice.

Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, <14 days, 3 months, and 6 months)


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Patients With 7-day Sustained Smoking Abstinence Reported in the Patient Survey [ Time Frame: 6 months (after baseline) ]
    7-day sustained smoking abstinence will be measured by the question "Have you smoked a cigarette (or other tobacco products), even a puff, in the last 7 days?" in patient survey.


Secondary Outcome Measures :
  1. Salivary Cotinine Test for Non-Smokers [ Time Frame: 6 months (after baseline) ]
    7-day Sustained Smoking abstinence will be validated using a salivary cotinine test in non smokers. Abstinence will be determined by percentage of smokers whose tests come back negative for cotinine. Low levels of cotinine less than 15 milligrams per milliliter (mg/mL) would suggest true smoking cessation and levels higher than or equal to 15 mg/mL would suggest they are still smoking.

  2. Short-term Smoking Abstinence - Patient Survey [ Time Frame: 3 months (after baseline) ]
    Short-tem smoking abstinence will be measured as part of the patient survey as the percentage of patients who report that they have not smoked.

  3. Total Number of Services Participant Reported Received at 14 Days [ Time Frame: <= 14 days after baseline ]
    Fidelity to the intervention will be measured by a patient survey that asks patients if they received up to 18 cessation services during the screening visit. This is the total each participant reported receiving and can range from 0 to 18, with higher values representing more services.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Agrees to have NCORP research personnel serve as the study liaison and another person to serve as the cessation program champion.
  • Agrees to participate in all aspects of the intervention, randomization, and evaluation.
  • Agrees to participate in a confidential 1-on-1 semi-structured interview with the research team.
  • Agrees to have the interview taped, transcribed and qualitatively analyzed.
  • Age ≥18 years
  • Potential participants will be screened using the following question: "Do you smoke cigarettes every day, some days, or not at all?" (BRFSS). A current smoker is anyone responds "every day" or "some days".

Exclusion Criteria:

  • Current use (previous 30 days) of a tobacco dependence treatment including bupropion, varenicline, and nicotine replacement
  • Individuals who use e-cigarettes and who are not smoking cigarettes. Dual users (those who use both e-cigarettes and cigarettes) will still be included in the trial.
  • The presence of a physical or cognitive impairment that would prevent a person from engaging in survey research (such as blindness, deafness, or dementia).
  • Individual has already completed the intended LDCT lung cancer screening for this study.
  • Non-English speaking participants.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291587


Locations
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Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
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Study Chair: Kristie Foley, PhD Wake Forest University Health Sciences
  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:
Study Protocol and Statistical Analysis Plan  [PDF] December 10, 2019
Informed Consent Form  [PDF] December 10, 2019

More Information
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Additional Information:

Publications:
G.A. Colditz. The promise and challenges of dissemination and implementation research. In: Dissemination and Implementation Research in Health. New York: Oxford University Press; 2012.
Fiore M, Jaen C, Baker T, Bailey W, Benowitz N, Curry S. Treating Tobacco Use and Dependence: 2008 Update - TreatingTobaccoUseandDependence-2008Update.pdf. http://www.aafp.org/dam/AAFP/documents/patient_care/clinical_recommendations/TreatingTobaccoUseandDependence-2008Update.pdf. Published 2008. Accessed January 11, 2017.
Holt DT, Armenakis AA, Feild HS, Harris SG. Readiness for Organizational Change: The Systematic Development of a Scale. J Appl Behav Sci. 2007;43(2):232-255. doi:10.1177/0021886306295295.
D'Agostino R, Karter A, Lang W, Walkup M, Morgan T. Examining the impact of missing data on propensity score estimation in determining the effectiveness of self-monitoring of blood glucose (SMBG). Health Serv Outcomes Res Methodol. 2001;2:291-315.
D'Agostino RB, Rubin DB. Estimating and Using Propensity Scores with Partially Missing Data. J Am Stat Assoc. 2000;95(451):749-759. doi:10.2307/2669455.

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03291587    
Other Study ID Numbers: IRB00040071
1R01CA207158-01 ( U.S. NIH Grant/Contract )
REBAWF-20817CD ( Other Identifier: NCI )
NCI-2017-01669 ( Registry Identifier: NCI CTRP )
First Posted: September 25, 2017    Key Record Dates
Results First Posted: July 25, 2022
Last Update Posted: July 25, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Wake Forest (WF) NCORP Research Base (RB) is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI National Clinical Trials Network (NCTN)/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials (https://nctn-data-archive.nci.nih.gov/). This will become the primary means for sharing raw data and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide.
Time Frame: see NIH policy
Access Criteria: request using uniform resource locator (URL) below
URL: https://nctn-data-archive.nci.nih.gov/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
lung cancer
cancer screening
tobacco use