Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Location status: Recruiting
Location contact
Ronald Myers
CONTACT
NCT Number: NCT05679349
This clinical trial tests how well providing education improves screening for lung cancer in patients with a history of smoking. Screenings may help doctors find lung cancer sooner when it may be easier to treat. Education and counseling may be an effective method to help providers and patients learn about lung cancer screening. Providing education and decision counseling to providers and patients may increase lung cancer screening.
Interested in participating?
Request Info50 year–77 year
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19107, United States
Location status: Recruiting
Ronald Myers
CONTACT
PRIMARY OBJECTIVES:
I. Assess intervention impact on lung cancer screening (LCS). II. Assess intervention impact on shared decision making (SDM).
SECONDARY OBJECTIVES:
I. Identify mediators and moderators of LCS. II. Assess intervention implementation barriers and facilitators.
EXPLORATORY OBJECTIVES:
I. Assess intervention impact on:
Ia. LCS referral; Ib. Tobacco treatment services referral; Ic. Repeat annual LCS among participants with a normal initial screening result; Id. Follow-up diagnostic evaluation for participants with an abnormal screening result.
OUTLINE: In accordance with the 2X2 cluster randomized design, primary care practices along with providers initially are randomized to 1 of 2 groups. Then, patients within the practices are randomized to 1 of 2 groups.
PROVIDERS:
GROUP A: PROVIDER SUPPORT GROUP: Providers complete baseline and endpoint surveys once on study. Providers also undergo online educational activity on study. Participants undergo distance learning on study.
GROUP B: PROVIDER CONTROL GROUP: Participants complete baseline and endpoint surveys once on study.
PATIENTS:
GROUP A: PROVIDER SUPPORT + PATIENT OUTREACH GROUP: Providers receive support once on study. Patients undergo educational activity and SDM counseling once on study and complete baseline and endpoint surveys.
GROUP B: PROVIDER SUPPORT + PATIENT CONTROL GROUP: Providers receive support once on study. Patients receive usual care once on study and complete baseline and endpoint telephone surveys.
GROUP C: PROVIDER CONTROL + PATIENT OUTREACH GROUP: Providers receive usual care once on study. Patients undergo educational activity and SDM counseling once on study and complete baseline and endpoint surveys.
Group D: PROVIDER CONTROL + PATIENT CONTROL GROUP: Providers receive usual care once on study. Patients receive usual care once on study and complete baseline and endpoint telephone surveys.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Complete survey
Undergo online shared decision making training and distance learning
Undergo electronic health record review
Undergo shared decision making counseling
Other names: Counseling Intervention
Time frame: Within 4 months of randomization
LCS will be assessed through an endpoint electronic medical records (EMR) search, supplemented with a question on the participant endpoint survey to capture any LCS performed outside the health system and/or not captured in the EMR.
Time frame: Up to 5 years
Referrals for lung cancer screenings will be found by reviewing electronic medical records.
Time frame: Up to 5 years
Referrals for tobacco treatment services will be found by reviewing medical records.
Time frame: within 11-16 months of original screening
Number of repeat screenings will be found by reviewing electronic medical records.
Time frame: Up to 4 months of screening
Number of patients that had follow up within 4 months of initial lung cancer screening will be found by reviewing electronic medical records.
Contact information is provided by the study sponsor or research team.
Ronald Myers
Other
Provider Support and Patient Outreach in Lung Cancer Screening
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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