Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01CA258849 | U.S. NIH Grant/Contract | View source | |
| JT 24704 | Other Identifier | JeffTrial Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Providers): (survey, online educational activity) | Experimental | Participants complete survey on study. Participants undergo online educational activity on study. Participants undergo distance learning on study. |
|
| Group B (Providers): (survey) | Active Comparator | Participants complete survey at baseline and end of study survey. |
|
| Group A (Patients): (EHR, educational activity, counseling)) | Experimental | Patients undergo EHR review on study. Patients undergo educational activity on study. Patients also undergo SDM counseling once on study. |
|
| Group B (Patients): (survey) | Active Comparator | Patients undergo EHR review on study and complete telephone survey throughout the trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survey Administration | Other | Complete survey |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Completion of initial lung cancer screening (LCS) | 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. | Within 4 months of randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Referral for LCS | Referrals for lung cancer screenings will be found by reviewing electronic medical records. | Up to 5 years |
| Tobacco cessation services | Referrals for tobacco treatment services will be found by reviewing medical records. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
PATIENT OUTREACH:
Any lung computed tomography (CT) or low-dose computed tomography (LDCT) scan in the past 11 months, current procedural terminology (CPT) Codes are as follows
Prior history of lung cancer (The patient's problem list includes a problem with an international classification of diseases (ICD10) code of "Z85.118" or one beginning with "C34.", or by self-report at baseline eligibility assessment)
Recent hospitalization (Admission date within the last 60 days listed in electronic health record (EHR), or by self-report at baseline eligibility assessment)
Dementia (diagnosis codes F03.90 or F03.91) in EHR
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ronald Myers, PhD | Contact | 215-503-4085 | ronald.myers@jefferson.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
| Educational Activity |
| Other |
Undergo online shared decision making training and distance learning |
|
| Survey Administration | Other | Complete survey |
|
| Electronic Health Record Review | Other | Undergo electronic health record review |
|
| Educational Activity | Other | Undergo online shared decision making training and distance learning |
|
| Counseling | Other | Undergo shared decision making counseling |
|
|
| Survey Administration | Other | Complete survey |
|
| Electronic Health Record Review | Other | Undergo electronic health record review |
|
| Up to 5 years |
| Repeat annual lung cancer screenings within 11-16 months of original screening | Number of repeat screenings will be found by reviewing electronic medical records. | within 11-16 months of original screening |
| Diagnostic follow up after initial lung cancer screening | Number of patients that had follow up within 4 months of initial lung cancer screening will be found by reviewing electronic medical records. | Up to 4 months of screening |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided