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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02267096
• Other study ID #: 2011-541
• Status: Completed
• Phase: Phase 3
• First received: October 7, 2014
• Last updated: October 18, 2016
• Start date: January 2014
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 80 Years

Eligibility

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 -

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Smoking

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Lahey Hospital and Medical Center	Burlington	Massachusetts
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	Prevent Cancer Foundation

Country where clinical trial is conducted

United States, 

References & Publications (3)

Barry SA, Tammemagi MC, Penek S, Kassan EC, Dorfman CS, Riley TL, Commin J, Taylor KL. Predictors of adverse smoking outcomes in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. J Natl Cancer Inst. 2012 Nov 7;104(21):1647-59. doi: 10.1093/jnci/djs398. Epub 2012 Oct 26. — View Citation

Tammemägi MC, Berg CD, Riley TL, Cunningham CR, Taylor KL. Impact of lung cancer screening results on smoking cessation. J Natl Cancer Inst. 2014 May 28;106(6):dju084. doi: 10.1093/jnci/dju084. Print 2014 Jun. — View Citation

Taylor KL, Cox LS, Zincke N, Mehta L, McGuire C, Gelmann E. Lung cancer screening as a teachable moment for smoking cessation. Lung Cancer. 2007 Apr;56(1):125-34. Epub 2006 Dec 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Status with biochemical verification	Self-reported 7-day and 30-day point prevalence abstinence with biochemical verification among those who report having quit smoking.	Measured at 3 months post-randomization	No
Secondary	Timeframe of Participants' Intention to Quit Smoking	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	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)	No
Secondary	Quit attempts	The questions are worded as follows: "How many times since our last interview have you quit smoking for 24 hours or longer?"; "What was the LONGEST period of time that you were able to not smoke cigarettes at all since the last interview?"	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)	No
Secondary	Cigarettes per day	The question is worded as follows: "Since our last interview, on average, how many cigarettes per day did you smoke?"; i did not smoke since the last interview; less than one per day; 1 per day; 2-5 per day; 6-10 per day; 11-20 per day; 20 per day; 21-40 per day; 41-60 per day; more than 3 packs per day	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)	No