Trial record 2 of 91 for:    national lung screening trial

Lombardi Comprehensive Cancer Center/Legacy Pilot Study to Reduce Adverse Smoking Outcomes in the Context of Lung Cancer Screening

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Georgetown University
Sponsor:
Collaborator:
Prevent Cancer Foundation
Information provided by (Responsible Party):
Kathryn L. Taylor, Ph.D., Georgetown University
ClinicalTrials.gov Identifier:
NCT02267096
First received: October 7, 2014
Last updated: July 31, 2015
Last verified: July 2015
  Purpose

In 2011, the National Lung Screening Trial (NLST) reported that lung cancer mortality was reduced by 20% with spiral computed tomography (CT) compared to chest X-ray. It is estimated that 8 million people in the US are at high risk for lung cancer and that lung screening could prevent 12,000 deaths annually. Cost effectiveness models suggest that concurrent smoking cessation programs will be essential in order to realize the full benefit of screening. However, there are no clinical guidelines or evidence-based cessation protocols with demonstrated effectiveness in this setting. The investigators are addressing this gap by rigorously testing whether two scalable and pragmatic interventions can significantly boost intention to quit and cessation rates.


Condition Intervention Phase
Smoking
Lung Cancer
Behavioral: Telephone Counseling
Behavioral: Minimal Treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lombardi Comprehensive Cancer Center/Legacy Pilot Study to Reduce Adverse Smoking Outcomes in the Context of Lung Cancer Screening

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Smoking Status with biochemical verification [ Time Frame: Measured at 3 months post-randomization ] [ Designated as safety issue: No ]
    Self-reported 7-day and 30-day point prevalence abstinence with biochemical verification among those who report having quit smoking.


Secondary Outcome Measures:
  • Timeframe of Participants' Intention to Quit Smoking [ Time Frame: Measured at each assessment: baseline (T0), 1-2 days post-receipt of screening result (T1), one-month post-randomization (T2), and 3 months post randomization (T2) ] [ Designated as safety issue: No ]

    At each assessment, the investigators will ask for the timeframe of participants' intention to quit smoking. The question is worded as: "Next are statements that smokers and former smokers have said about quitting. Please tell me which statement best represents what you think right now."

    1____ I enjoy smoking so much I will never consider quitting no matter what happens 2 ____ I never think about quitting but I might someday 3 ____I rarely think about quitting and have no specific plans to quit 4 ____I sometimes think about quitting but have no specific plans to quit 5 ____I often think about quitting but have no specific plans to quit 6 ____I plan to quit in the next 6 months 7 ____I plan to quit in the next 30 days 8 ____I have already begun to cut down and I have set a quit date


  • Quit attempts [ Time Frame: Measured at each assessment: baseline (T0), 1-2 days post-receipt of screening result (T1), one-month post-randomization (T2), and 3 months post randomization (T2) ] [ Designated as safety issue: No ]

    The questions are worded as follows:

    1. "How many times since our last interview have you quit smoking for 24 hours or longer?"
    2. "What was the LONGEST period of time that you were able to not smoke cigarettes at all since the last interview?"

  • Cigarettes per day [ Time Frame: Measured at each assessment: baseline (T0), 1-2 days post-receipt of screening result (T1), one-month post-randomization (T2), and 3 months post randomization (T2) ] [ Designated as safety issue: No ]

    The question is worded as follows: "Since our last interview, on average, how many cigarettes per day did you smoke?"

    1. i did not smoke since the last interview
    2. less than one per day
    3. 1 per day
    4. 2-5 per day
    5. 6-10 per day
    6. 11-20 per day
    7. 20 per day
    8. 21-40 per day
    9. 41-60 per day
    10. more than 3 packs per day


Estimated Enrollment: 100
Study Start Date: January 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telephone Counseling (TC)
The TC arm will receive the list of minimal treatment interventions plus 3-6 sessions of stepped-care, proactive, telephone counseling.
Behavioral: Telephone Counseling
The TC arm includes a stepped care approach, 3-6 phone sessions, depending on each participant's needs. Within 1-2 days post-T1 assessment, the intervention will begin. Sessions 1-3 (15 min each) will occur approximately weekly over 3-4 weeks, scheduled at participants' convenience and at strategic therapeutic times (e.g., shortly pre/post-quit date). Continuing smokers or newly quit former smokers who would benefit from relapse prevention sessions will receive up to 3 additional sessions, to be completed within 3-4 weeks. The provision of 3-6 sessions is more intensive than several other telephone counseling interventions. A dose response relationship between quitting and number of sessions has been shown in non-volunteer smokers, and based on our pilot data, the investigators expect that a more intensive intervention will be needed for some participants.
Behavioral: Minimal Treatment
A list of self-help materials (print-, web-, phone-based), the national telephone quitline phone number, and local in person cessation resources will be given to all participants.
Active Comparator: Minimal Treatment
The minimal treatment intervention includes a list of print, online, national telephone quitline phone number, and in-person cessation resources that is sent to participants.
Behavioral: Minimal Treatment
A list of self-help materials (print-, web-, phone-based), the national telephone quitline phone number, and local in person cessation resources will be given to all participants.

Detailed Description:

Although abstinence from tobacco remains the best method of lung cancer prevention, recent evidence from the National Lung Screening Trial indicated that lung cancer mortality was reduced by 20% with spiral computed tomography (CT) compared to chest X-ray. As a result, the United States Preventive Services Task Force now recommends lung cancer screening for high risk individuals (long-term current and former smokers, 55-80 years old). It is estimated that 8 million people in the US are at high risk and that lung screening could prevent 12,000 deaths annually. Cost effectiveness models suggest that concurrent smoking cessation programs will be essential in order to realize the full benefit of screening. However, there are no clinical guidelines or evidence-based cessation protocols with demonstrated effectiveness in this setting. The investigators propose to address this gap by rigorously testing whether two scalable and pragmatic interventions (minimal and moderate in intensity) can significantly boost intention to quit and cessation rates. The investigators will capitalize on the critical 'teachable moment' of learning of one's screening result. Incorporation of an individual's screening result into a cessation intervention will test the innovative question of whether intention to quit can be enhanced and reduced intention to quit can be minimized, when an individualized, motivational telephone-based intervention is provided. Method: The investigators will accrue current smokers from the lung cancer screening programs at three sites: Georgetown University Hospital, Lahey Hospital, and Hackensack University Hospital. Prior to screening, 100 participants will be consented, enrolled, and will complete the baseline (T0) phone interview. Within 1-2 days of receiving the result, participants will be randomly assigned to Minimal Treatment (MT) vs. Telephone Counseling (TC). Both arms will receive the minimal treatment intervention (a list of print, online, quitline, and in-person cessation resources). The TC arm will receive 3-6 sessions of stepped-care, proactive, telephone counseling with the same Tobacco Treatment Specialist for both sites. Both arms will be assessed at 3-months post randomization for tobacco use outcomes. The specific aims are: 1) To conduct a two-arm randomized cessation intervention trial (MT vs. TC) with current smokers undergoing screening. 2) The investigators will explore moderators and mediators of the interventions' effect on cessation outcomes. Moderators include the screening result, race, gender, age, and nicotine dependence. Mediators include teachable moment factors, baseline intention to quit, and process measures. Summary: This proof of concept study will determine intervention feasibility, effect sizes needed for a larger study, and potential moderators and mediators of the intervention. The long-term goal is to evaluate the intervention in a multisite trial and ultimately, to disseminate it for use by lung cancer screening programs. The innovation of this proposal is in joining disease prevention (smoking cessation) with early detection in a medical setting that has relevance for a substantial proportion of current smokers, suggesting that even a small increase in cessation has the potential for a very large public health benefit.

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 55-80 years old
  2. current smoker
  3. > 30-pack years
  4. English-speaking
  5. ability to provide meaningful consent
  6. enrolled to undergo lung cancer screening. -

Exclusion Criteria:

  1. history of lung cancer
  2. current treatment for other cancer -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02267096

Contacts
Contact: Kathryn L Taylor, PhD 202-687-0649 taylorkl@georgetown.edu
Contact: Charlotte J. Hagerman, BA 202-687-2715 cjh243@georgetown.edu

Locations
United States, District of Columbia
Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Kathryn L. Taylor, PhD    202-687-0649    taylorkl@georgetown.edu   
Principal Investigator: Kathryn L. Taylor, Ph.D.         
United States, Massachusetts
Lahey Hospital and Medical Center Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Shawn Regis, PhD    781-744-7890    shawn.m.regis@lahey.org   
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Michael Ramsaier    551-996-3384    mramsaier@hackensackumc.org   
Sponsors and Collaborators
Georgetown University
Prevent Cancer Foundation
  More Information

Publications:
Responsible Party: Kathryn L. Taylor, Ph.D., Professor, Department of Oncology, Georgetown University
ClinicalTrials.gov Identifier: NCT02267096     History of Changes
Other Study ID Numbers: 2011-541
Study First Received: October 7, 2014
Last Updated: July 31, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
lung cancer screening

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on August 27, 2015