Nicotine Patches, Nicotine Lozenges, Individualized Quitting Messages, and Motivational Interviewing at Lung Cancer Screening Sites in Helping Current Smokers Reduce or Quit Smoking, CASTL study
Lung Cancer
Unknown Primary
50 - 80 Years, Male and Female
17-500 (primary)
NCI-2017-02050
Summary
This randomized phase IV trial studies how well nicotine patches, nicotine lozenges, individualized quitting messages, and motivational interviewing at lung cancer screening sites work in helping current smokers reduce or quit smoking. Nicotine patches, nicotine lozenges, individualized quitting messages, or motivational interviewing may help doctors determine the best type of treatment, or combination of treatments, to offer patients who are current smokers in order to help reduce the number of cigarettes smoked or quit smoking. It may also increase the benefits of lung cancer screening by providing a blue print of best practices for screening sites to deliver tobacco treatment to their patients who are smokers, in a way that does not add burden to screening site staff and increases the chances of patients quitting smoking.
Objectives
PRIMARY OBJECTIVES:
I. To use a highly efficient Multiphase Optimization Strategy (MOST) design to identify which of four evidence-based tobacco treatment components contribute to superior cessation endpoints among current smokers seeking lung cancer screening.
II. To estimate the cost and incremental cost-effectiveness of evidence-based tobacco treatment components, delivered alone and in combination.
III. To conduct a robust, mixed methods evaluation of the implementation process and assess organizational factors that may influence dissemination and implementation of delivering effective models for smoking cessation treatment in lung cancer screening settings.
IV. To gain a better understanding of factors impacting refusal among African-American smokers using a rigorous qualitative approach. (PACT ancillary study)
OUTLINE: Participants are randomized to 1 of 16 groups. African-Americans who refuse participation in the study, are assigned to the Sub-Study arm.
GROUP 1: Participants receive a printed individualized quitting message that emphasizes the risks of continuing to smoke (loss-framed) and receive two motivational interviewing counseling sessions, the first delivered face to face or via telephone by the study coordinator (SC) during the participant’s initial lung cancer screening visit or within 1 week after the screening visit and the second session delivered via telephone by the SC 4-8 weeks after the first session. Patients also receive enhanced standard of care consisting of self-help cessation materials and referral to the Quitline.
GROUP 2: Participants receive a printed individualized quitting message that emphasizes the benefits of quitting (gain-framed) and receive motivational interviewing counseling sessions enhanced standard of care as in Group 1.
GROUP 3: Participants receive loss-framed message, motivational interviewing, and enhanced standard of care as in Group 1. Participants also receive six weeks of nicotine replacement therapy (NRT) patch (over the counter).
GROUP 4: Participants receive gain-framed message as in Group 2, motivational interviewing and enhanced standard of care as in Group 1, and six weeks of NRT patch as in Group 3.
GROUP 5: Participants receive loss-framed message, motivational interviewing, and enhanced standard of care as in Group 1. Participants also receive six packs of NRT lozenge with written instructions to use the lozenge as needed (pro re nata [PRN]) to help manage acute nicotine withdrawal.
GROUP 6: Participants receive gain-framed message as in Group 2, six packs of NRT lozenge as in Group 5, and motivational interviewing and enhanced standard of care as in Group 1.
GROUP 7: Participants receive loss-framed message, motivational interviewing, and enhanced standard of care as in Group 1. Participants also receive six weeks of NRT patch as in Group 3, and six packs of NRT lozenge as in Group 5.
GROUP 8: Participants receive gain-framed message as in Group 2, motivational interviewing and enhanced standard of care as in Group 1, six weeks of NRT patch as in Group 3, and six packs of NRT lozenge as in Group 5.
GROUP 9: Participants receive loss-framed message and enhanced standard of care as in Group 1.
GROUP 10: Participants receive gain-framed message as in Group 2 and enhanced standard of care as in Group 1.
GROUP 11: Participants receive loss-framed message and enhanced standard of care as in Group 1. Participants also receive six weeks of NRT patch as in Group 3.
GROUP 12: Participants receive gain-framed message as in Group 2, enhanced standard of care as in Group 1, and six weeks of NRT patch as in Group 3.
GROUP 13: Participants receive loss-framed message and enhanced standard of care as in Group 1. Participants also receive six packs of NRT lozenge as in Group 5.
GROUP 14: Participants receive gain-framed message as in Group 2, enhanced standard of care as in Group 1, and six packs of NRT lozenge as in Group 5.
GROUP 15: Participants receive loss-framed message and enhanced standard of care as in Group 1. Participants also receive six weeks of NRT patch as in Group 3 and six packs of NRT lozenge as in Group 5.
GROUP 16: Participants receive gain-framed message as in Group 2, enhanced standard of care as in Group 1, six weeks of NRT patch as in Group 3 and six packs of NRT lozenge as in Group 5.
After completion of study, participants are followed up at 3 and 6 months.
SUB-STUDY: Participants complete an interview over 30 minutes.
Eligibility
- SITE ELIGIBILITY (AS PER SC SELF-REPORT)
- Must be designated as an American College of Radiology (ACR) designated lung cancer screening site
- Reports at least one year of lung cancer screening experience
- Reports conducting at least 20 new initial screenings per month
- SITE COORDINATOR (SC) ELIGIBILITY (AS PER SELF-REPORT)
- Employed at participating lung cancer screening site
- PATIENT ELIGIBILITY (AS PER SELF-REPORT)
- Between the ages of 50-80 years old (at the time of their scheduled or completed low dose computed tomography [LDCT] scan)
- Has a scheduled baseline or annual follow-up low dose computed tomography (LDCT) lung cancer screening within 60 business days OR has had a baseline or annual follow-up LDCT lung cancer screening within the last 60 business days and received the result for that scan OR has had a baseline or annual follow-up LDCT lung cancer screening but has not received the result for that scan
- Have at least a 20 pack-year history of smoking (per site report)
- Currently a smoker, defined as self-reported cigarette smoking (some days, every day) within the past 30 days
- Must be reachable by telephone
- Must be English or Spanish speaking due to the study materials being available only these languages and limited available resources for translation
- PACT ANCILLARY STUDY PATIENT ELIGIBILITY: Listed as eligible for CASTL by the site as per the site weekly log
- PACT ANCILLARY STUDY PATIENT ELIGIBILITY: Self-Identifies as African-American on the site weekly log
- PACT ANCILLARY STUDY PATIENT ELIGIBILITY: Refused participation to CASTL either actively (communicated they are not interested) or passively (did not respond to an invitation to CASTL)
- PACT ANCILLARY STUDY PATIENT ELIGIBILITY: Must be reachable by telephone
- PACT ANCILLARY STUDY PATIENT ELIGIBILITY: Must be English speaking due to the study materials being available in English only and limited available resources for translation
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
Click here to learn more about clinical trials.