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Smoking CessationOaSiSNCT03291587

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

A study testing Personnel Training and Coaching Calls in people with Smoking Cessation, run by Wake Forest University Health Sciences at 49 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Smoking Cessation
What is being tested?
Personnel Training and Coaching Calls
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,094 participants
Where
49 sitesUnited States
Study dates
1 Jun 2018to 22 Feb 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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".

Who cannot join

  • 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.

Trial locations and contacts

49 sites in 1 country.

49 sites in 1 country

United States49 sites

  • McFarland Clinic PC - Ames

    Ames, Iowa, 50010

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • Saint Louis Cancer and Breast Institute-Ballwin

    Ballwin, Missouri, 63011

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

  • Cox Cancer Center Branson

    Branson, Missouri, 65616

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Prisma Health Cancer Institute - Laurens

    Clinton, South Carolina, 29325

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Sanford South University Medical Center

    Fargo, North Dakota, 58103

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859

  • Freeman Health System

    Joplin, Missouri, 64804

  • Mercy Hospital Joplin

    Joplin, Missouri, 64804

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Baptist Memorial Hospital and Cancer Center-Memphis

    Memphis, Tennessee, 38120

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Mercy Hospital Oklahoma City

    Oklahoma City, Oklahoma, 73120

  • Saint Mary's Regional Medical Center

    Reno, Nevada, 89503

  • VCU Massey Cancer Center at Stony Point

    Richmond, Virginia, 23235

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • Delbert Day Cancer Institute at PCRMC

    Rolla, Missouri, 65401

  • Mercy Clinic-Rolla-Cancer and Hematology

    Rolla, Missouri, 65401

  • William Beaumont Hospital-Royal Oak

    Royal Oak, Michigan, 48073

  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

    Savannah, Georgia, 31405

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672

  • LSU Health Sciences Center at Shreveport

    Shreveport, Louisiana, 71103

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Saint Louis Cancer and Breast Institute-South City

    St Louis, Missouri, 63109

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Mercy Hospital Washington

    Washington, Missouri, 63090

  • Novant Health Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: Implementation Of Smoking Cessation Services Within NCI NCORP Community Sites With Organized Lung Cancer Screening Programs

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.

Read the 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.

Being tested
Personnel Training and Coaching Calls
Keywords
lung cancer, cancer screening, tobacco use
Medical subject headings
Smoking Cessation, Lung Neoplasms, Tobacco Use

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personnel Training and Coaching CallsOther

    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.

Study groups in NCT03291587
Study groupRoleWhat they receive
InterventionExperimentalTraining 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)
Receives: Other: Personnel Training and Coaching Calls
Usual CareNo interventionNo 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)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Patients With 7-day Sustained Smoking Abstinence Reported in the Patient Survey

    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.

    Measured: 6 months (after baseline)

Secondary outcomes (3)

  1. Salivary Cotinine Test for Non-Smokers

    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.

    Measured: 6 months (after baseline)

  2. Short-term Smoking Abstinence - Patient Survey

    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.

    Measured: 3 months (after baseline)

  3. Total Number of Services Participant Reported Received at 14 Days

    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.

    Measured: <= 14 days after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2017
  2. Study start1 Jun 2018
  3. Primary completion22 Feb 2021
  4. Study completion22 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,094 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03291587
Sponsor's protocol ID
IRB00040071
Other IDs
1R01CA207158-01, REBAWF-20817CD, NCI-2017-01669
Acronym
OaSiS
Status last verified
Jul 2022
First submitted
19 Sep 2017
Last updated
25 Jul 2022
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.

    PubMed 21714641

  • Taylor DH Jr, Hasselblad V, Henley SJ, Thun MJ, Sloan FA. Benefits of smoking cessation for longevity. Am J Public Health. 2002 Jun;92(6):990-6. doi: 10.2105/ajph.92.6.990.

    PubMed 12036794

  • Hermanson B, Omenn GS, Kronmal RA, Gersh BJ. Beneficial six-year outcome of smoking cessation in older men and women with coronary artery disease. Results from the CASS registry. N Engl J Med. 1988 Nov 24;319(21):1365-9. doi: 10.1056/NEJM198811243192101.

    PubMed 3185646

  • Gellert C, Schottker B, Brenner H. Smoking and all-cause mortality in older people: systematic review and meta-analysis. Arch Intern Med. 2012 Jun 11;172(11):837-44. doi: 10.1001/archinternmed.2012.1397.

    PubMed 22688992

  • Parsons A, Daley A, Begh R, Aveyard P. Influence of smoking cessation after diagnosis of early stage lung cancer on prognosis: systematic review of observational studies with meta-analysis. BMJ. 2010 Jan 21;340:b5569. doi: 10.1136/bmj.b5569.

    PubMed 20093278

  • Black WC, Gareen IF, Soneji SS, Sicks JD, Keeler EB, Aberle DR, Naeim A, Church TR, Silvestri GA, Gorelick J, Gatsonis C; National Lung Screening Trial Research Team. Cost-effectiveness of CT screening in the National Lung Screening Trial. N Engl J Med. 2014 Nov 6;371(19):1793-802. doi: 10.1056/NEJMoa1312547.

    PubMed 25372087

  • McMahon PM, Kong CY, Bouzan C, Weinstein MC, Cipriano LE, Tramontano AC, Johnson BE, Weeks JC, Gazelle GS. Cost-effectiveness of computed tomography screening for lung cancer in the United States. J Thorac Oncol. 2011 Nov;6(11):1841-8. doi: 10.1097/JTO.0b013e31822e59b3.

    PubMed 21892105

  • Zeliadt SB, Heffner JL, Sayre G, Klein DE, Simons C, Williams J, Reinke LF, Au DH. Attitudes and Perceptions About Smoking Cessation in the Context of Lung Cancer Screening. JAMA Intern Med. 2015 Sep;175(9):1530-7. doi: 10.1001/jamainternmed.2015.3558.

    PubMed 26214612

  • Moyer VA; U.S. Preventive Services Task Force. Screening for lung cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014 Mar 4;160(5):330-8. doi: 10.7326/M13-2771.

    PubMed 24378917

  • Ostroff JS, Copeland A, Borderud SP, Li Y, Shelley DR, Henschke CI. Readiness of Lung Cancer Screening Sites to Deliver Smoking Cessation Treatment: Current Practices, Organizational Priority, and Perceived Barriers. Nicotine Tob Res. 2016 May;18(5):1067-75. doi: 10.1093/ntr/ntv177. Epub 2015 Sep 7.

    PubMed 26346948

  • Clinical Practice Guideline Treating Tobacco Use and Dependence 2008 Update Panel, Liaisons, and Staff. A clinical practice guideline for treating tobacco use and dependence: 2008 update. A U.S. Public Health Service report. Am J Prev Med. 2008 Aug;35(2):158-76. doi: 10.1016/j.amepre.2008.04.009.

    PubMed 18617085

  • Tong EK, Strouse R, Hall J, Kovac M, Schroeder SA. National survey of U.S. health professionals' smoking prevalence, cessation practices, and beliefs. Nicotine Tob Res. 2010 Jul;12(7):724-33. doi: 10.1093/ntr/ntq071. Epub 2010 May 27.

    PubMed 20507899

  • Okuyemi KS, Reitzel LR, Fagan P. Interventions to Reduce Tobacco-Related Health Disparities. Nicotine Tob Res. 2015 Aug;17(8):887-91. doi: 10.1093/ntr/ntv096. No abstract available.

    PubMed 26180213

  • Foley KL, Pockey JR, Helme DW, Song EY, Stewart K, Jones C, Spangler JG, Sutfin EL. Integrating evidence-based tobacco cessation interventions in free medical clinics: opportunities and challenges. Health Promot Pract. 2012 Sep;13(5):687-95. doi: 10.1177/1524839911433465. Epub 2012 Mar 30.

    PubMed 22467664

  • Pockey JR, Song EY, Sutfin EL, Spangler JG, Jones C, Helme DW, Foley KL. The need for tobacco cessation in a free clinic population. Addict Behav. 2012 Dec;37(12):1299-302. doi: 10.1016/j.addbeh.2012.03.032. Epub 2012 Jul 4.

    PubMed 22958861

Questions about this trial

What is this clinical trial studying?

A study testing Personnel Training and Coaching Calls in people with Smoking Cessation, run by Wake Forest University Health Sciences at 49 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients With 7-day Sustained Smoking Abstinence Reported in the Patient Survey (time frame: 6 months (after baseline)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03291587, which also lists 52 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.

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