Best Practice
OtherReceive usual care counseling
Other names: standard of care, standard therapy
NCT Number: NCT04200534
This trial studies how well a centralized care strategy works in improving the quality of smoking cessation and shared decision making among patients who smoke and are considering lung cancer screening. The centralized care strategy is a model where smokers eligible for lung cancer screening are referred to a dedicated tobacco treatment program where they receive both the shared decision-making and initiate smoking cessation counseling prior to their visit with a primary care provider. Utilizing the centralized care model may work better in helping people quit smoking and make informed decisions about lung cancer screening compared to usual care.
This study is active but is not currently recruiting participants.
55 year–77 year
All sexes
Interventional
Early Phase 1
University of Texas Medical Branch, Galveston, Texas, United States
PRIMARY OBJECTIVE:
I. Test the effectiveness of usual care (primary care providers with training in guideline-based smoking cessation and shared decision making) versus (vs.) centralized care (smoking cessation and shared decision making delivered remotely by trained counselors) on smoking abstinence and the quality of patients' decisions about lung cancer screening.
SECONDARY OBJECTIVES:
I. Evaluate the reach, acceptability, feasibility, and fidelity of the two smoking cessation and shared decision-making implementation models in meeting the requirements from Centers for Medicare & Medicaid Services (CMS) for the lung cancer screening patient counseling and shared decision making visit.
II. Conduct budget impact and cost-effectiveness analyses of the two implementation models for the smoking cessation and shared decision making to inform adoption of the intervention beyond the current study.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I (CENTRALIZED CARE): Participants receive counseling over the phone to help them quit smoking and learn about lung cancer screening over 15-20 minutes for 6-8 sessions over 8 weeks. Participants may also receive nicotine patches.
GROUP II (USUAL CARE): Participants receive counseling on lung cancer screening and smoking cessation from primary care providers at health care visit.
After completion of study, participants are followed up at 1, 8, and 12 weeks.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Receive usual care counseling
Other names: standard of care, standard therapy
Given nicotine patches
Other names: NicoDerm CQ, Nicotine Skin Patch, Nicotine Transdermal Patch
Ancillary studies
Other names: Quality of Life Assessment
Ancillary studies
Receive counseling over the phone
Time frame: Up to 12 weeks
Participants achieving the primary abstinence endpoint at 12 weeks (higher 7-day point prevalence abstinence rates)
Time frame: Up to 12 weeks
Knowledge of lung cancer screening and benefits of smoking cessation
Time frame: Up to 12 weeks
Assessment of the reach of the intervention
Time frame: Up to 12 weeks
Assessment of the feasibility of implementing the intervention
Time frame: Up to 12 weeks
Assessment of the feasibility of implementing the intervention
Time frame: Up to 12 weeks
Standardized measure of health-related quality of life used to generate patient utilities (will report lower decisional conflict, greater decision preparation, greater intention to stop smoking, and be more likely to make an attempt to stop smoking.)
Time frame: Up to 12 weeks
Costs of personnel, hardware, and delivering materials to participants
M.D. Anderson Cancer Center
Other
Improving the Quality of Smoking Cessation and Shared Decision Making for Lung Cancer Screening: A Cluster Randomized Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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