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

NCT03291587 | Completed Results DMC

• 4 other identifiers: IRB000400711R01CA207158-01REBAWF-20817CDNCI-2017-01669
• Study Type: interventional
• Target: 1,094
• Locations: 1 country
• Sites: 49

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.

Conditions

Smoking Cessation

Keywords

lung cancer; cancer screening; tobacco use

Outcome Measures

Primary Outcomes (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.

  6 months (after baseline)

Secondary Outcomes (3)

• Salivary Cotinine Test for Non-Smokers

  6 months (after baseline)

• Short-term Smoking Abstinence - Patient Survey

  3 months (after baseline)

• Total Number of Services Participant Reported Received at 14 Days

  <= 14 days after baseline

Study Arms (2)

Intervention

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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)

Interventions

Personnel Training and Coaching Calls OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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".

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (49)

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

Location

Augusta University Medical Center

Augusta, Georgia, 30912, United States

Location

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

Savannah, Georgia, 31405, United States

Location

Tripler Army Medical Center

Honolulu, Hawaii, 96859, United States

Location

Good Samaritan Regional Health Center

Mount Vernon, Illinois, 62864, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

McFarland Clinic PC - Ames

Ames, Iowa, 50010, United States

Location

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

Location

LSU Health Sciences Center at Shreveport

Shreveport, Louisiana, 71103, United States

Location

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States

Location

Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, 49503, United States

Location

William Beaumont Hospital-Royal Oak

Royal Oak, Michigan, 48073, United States

Location

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

Location

Saint Louis Cancer and Breast Institute-Ballwin

Ballwin, Missouri, 63011, United States

Location

Central Care Cancer Center - Bolivar

Bolivar, Missouri, 65613, United States

Location

Cox Cancer Center Branson

Branson, Missouri, 65616, United States

Location

Freeman Health System

Joplin, Missouri, 64804, United States

Location

Mercy Hospital Joplin

Joplin, Missouri, 64804, United States

Location

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, 65401, United States

Location

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, 65401, United States

Location

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

Location

CoxHealth South Hospital

Springfield, Missouri, 65807, United States

Location

Saint Louis Cancer and Breast Institute-South City

St Louis, Missouri, 63109, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

Location

Mercy Hospital Washington

Washington, Missouri, 63090, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

Saint Mary's Regional Medical Center

Reno, Nevada, 89503, United States

Location

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States

Location

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Sanford South University Medical Center

Fargo, North Dakota, 58103, United States

Location

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122, United States

Location

Adena Regional Medical Center

Chillicothe, Ohio, 45601, United States

Location

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, 73120, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, 29316, United States

Location

Prisma Health Cancer Institute - Laurens

Clinton, South Carolina, 29325, United States

Location

Prisma Health Cancer Institute - Easley

Easley, South Carolina, 29640, United States

Location

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, 29605, United States

Location

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States

Location

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States

Location

Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650, United States

Location

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672, United States

Location

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, 38120, United States

Location

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, 23235, United States

Location

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

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Related Links

• Medicare Coverage Database - Centers for Medicare \& Medicaid Services
• Bradley EH, Pallas S, Bashyal C, Berman P, Curry L. Developing Strategies for Improving Health Care Delivery : Guide to Concepts, Determinants, Measurement, and Intervention Design. June 2010.
• Johnson. HR at MIT \| Learning \& Development \| What is Coaching?

MeSH Terms

Conditions

Smoking Cessation; Lung Neoplasms; Tobacco Use

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

Some sites dropped out early and did not accrue all 50 participants.

Results Point of Contact

• Title: Lead Biostatistician
• Organization: Wake Forest NCORP Research Base

NCORP@wakehealth.edu

3367160891

Study Officials

• Kristie Foley, PhD

  Wake Forest University Health Sciences

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 25, 2017
• Study Start: June 1, 2018
• Primary Completion: February 22, 2021
• Study Completion: February 22, 2021
• Last Updated: July 25, 2022
• Results First Posted: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: see NIH policy
• Access Criteria: request using uniform resource locator (URL) below

Locations

US (49)