Lung Cancer Clinical Trial
— SDM-LCS-SCOfficial title:
Shared Decision Making in Rural Primary Care Lung Cancer Screening and Smoking Cessation
Verified date | March 2024 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The intervention is aimed to improve adherence to the lung cancer screening (LCS) guidelines and Centers for Medicare and Medicaid Services (CMS) coverage criteria to conduct shared decision-making (SDM) and provide smoking cessation services in rural primary care practices.
Status | Completed |
Enrollment | 118 |
Est. completion date | November 29, 2023 |
Est. primary completion date | April 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 80 Years |
Eligibility | Inclusion Criteria: - Asymptomatic to lung cancer symptoms - Tobacco smoking history of 20+ pack-years - Current smoker or quit within last 15 years Exclusion Criteria: - A patient that does not meet inclusion criteria |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Hospital | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | High Plains Research Network, National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Count of participants who's health visit adhered to the LCS guidelines and CMS coverage criteria in rural primary care practices: baseline survey | The adherence to the LCS guidelines and CMS coverage criteria to conduct SDM and provide smoking cessation services in rural primary care practices (is a latent variable) and will be measured as a composite measure using variables in a baseline survey administered immediately after healthcare provider's visit (baseline).
A survey tool will be developed and used to count "Yes" response to the following survey questions: Were you given a decision aid during your last clinic visit/call? Was the clinic provider or staff able to go over the decision aid together with you during your last clinic visit/call? Were you recommended for a low-dose CAT scan by your provider during your last clinic visit/call? |
Baseline | |
Primary | Count of participants who's health visit adhered to the LCS guidelines and CMS coverage criteria in rural primary care practices: follow-up survey | The adherence to the LCS guidelines and CMS coverage criteria to conduct SDM and provide smoking cessation services in rural primary care practices (is a latent variable) and will be measured as a composite measure using variables in a baseline survey administered immediately after the healthcare provider's visit (follow-up).
A survey tool will be developed and used to count "Yes" response to the following survey questions: Were you given a decision aid during your last clinic visit/call? Was the clinic provider or staff able to go over the decision aid together with you during your last clinic visit/call? Were you recommended for a low-dose computerized axial tomography (CAT) scan by your provider during your last clinic visit/call? |
1 month follow-up | |
Secondary | Patient knowledge about lung cancer | Patient knowledge about lung cancer will be measured by 5 survey questions previously used by Lau et al in their peer-reviewed manuscript published in the American Journal of Preventive Medicine titled Evaluation of a Personalized, Web-Based Decision Aid for Lung Cancer Screening. The level of knowledge will be assessed based on correct answers to the following survey questions:
Factors that increase chances of developing lung cancer include; Possible benefits of lung cancer screening are; Possible harms of lung cancer screening include; Please indicate whether each of the following individuals would be eligible for screening based on their age. They all meet the smoking status and pack-year criteria; What percentage of lumps found on your lungs by the CT screening is NOT going to be cancer? More correct answers indicate higher level of knowledge. |
Baseline | |
Secondary | Patient knowledge about lung cancer | Patient knowledge about lung cancer will be measured by 5 survey questions previously used by Lau et al in their peer-reviewed manuscript published in the American Journal of Preventive Medicine titled Evaluation of a Personalized, Web-Based Decision Aid for Lung Cancer Screening. The level of knowledge will be assessed based on correct answers to the following survey questions:
Factors that increase the chances of developing lung cancer include; Possible benefits of lung cancer screening are; Possible harms of lung cancer screening include; Please indicate whether each of the following individuals would be eligible for screening based on their age. They all meet the smoking status and pack-year criteria; What percentage of lumps found on your lungs by the CT screening is NOT going to be cancer? More correct answers indicate higher level of knowledge. |
1 month follow up |
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