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Clinical trial

Improving the Quality of Smoking Cessation and Shared Decision Making for Lung Cancer Screening: A Cluster Randomized Trial

ID
Name
2019-0265
Description
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.
Trial arms
Trial start
2020-07-31
Estimated PCD
2025-02-28
Trial end
2025-02-28
Status
Recruiting
Phase
Early phase I
Treatment
Best Practice
Receive usual care counseling
Arms:
Group II (usual care)
Other names:
standard of care, standard therapy
Nicotine Patch
Given nicotine patches
Arms:
Group I (centralized care strategy)
Other names:
NicoDerm CQ, Nicotine Skin Patch, Nicotine Transdermal Patch
Quality-of-Life Assessment
Ancillary studies
Arms:
Group I (centralized care strategy), Group II (usual care)
Other names:
Quality of Life Assessment
Questionnaire Administration
Ancillary studies
Arms:
Group I (centralized care strategy), Group II (usual care)
Tobacco Cessation Counseling
Receive counseling over the phone
Arms:
Group I (centralized care strategy)
Size
520
Primary endpoint
Smoking abstinence Questionnairre
Up to 12 weeks
Lung Cancer Screening 12 items version
Up to 12 weeks
Eligibility criteria
Inclusion Criteria: * PATIENTS: Primary care patients * PATIENTS: Upcoming primary care office visit * PATIENTS: Current smoker * PATIENTS: 30 plus (+) pack-year smoking history * PATIENTS: English-speaking * PROVIDERS: Primary health care providers * PROVIDERS: Provide care to adults Exclusion Criteria: * PATIENTS: History of lung cancer by self-report
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 520, 'type': 'ESTIMATED'}}
Updated at
2024-03-28

1 organization

1 product

2 indications

Organization
M.D. Anderson Cancer Center
Product
Nicotine
Indication
Tobacco use disorder
Indication
lung cancer