Lung CancerNCT05064046
Educating Providers About Lung Screening
A study testing LuCa + Health Disparity module in people with Lung Cancer, run by Georgetown University at 1 site in United States.
Trial summary
We are conducting a randomized trial to compare the Health Disparities module to an existing provider module on lung cancer screening to evaluate the impact on primary care providers' knowledge, attitudes, and lung cancer screening referrals of African American and White patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- LuCa + Health Disparity module
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2021to 27 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- MedStar provider (attending or resident physician, physician's assistant, or nurse practitioner)
- English speaking
- ability to provide meaningful consent
- ability to provide last two digits of NPI.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Health Georgetown University Hospital
Washington D.C., District of Columbia, 20007
About this study
Official title: Educating Providers About Health Disparities in Lung Cancer Screening
We are conducting a randomized trial to compare the Health Disparities module to an existing provider module on lung cancer screening to evaluate the impact on primary care providers' knowledge, attitudes, and lung cancer screening referrals of African American and White patients.
Read the detailed description
We are conducting a randomized trial of two online, provider-facing education modules regarding lung cancer screening and smoking cessation. We will accrue 70 MedStar primary care providers (PCP). The baseline survey will incorporate items regarding lung cancer screening knowledge, providers' attitudes towards lung cancer screening, lung cancer screening ordering practices and provider characteristics. At the end of the baseline survey, PCPs will be randomly assigned to the LuCa + Health Disparities or LuCa only. PCPs will be asked to complete the intervention and the post-test within 1 week of randomization. The post test will cover knowledge of lung cancer screening, attitudes and opinions toward LCS. To assess PCP lung cancer screening ordering practices, we will review the MedConnect Electronic Health Record (EHR) to compare the two study groups post-randomization on the number of orders made for LCS.
- Conditions
- Lung Cancer
- Being tested
- LuCa + Health Disparity module
- Keywords
- lung cancer screening, provider education, health disparities
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LuCa + Health Disparity moduleBehavioural
The Health Disparity course will review disparities in the burden of lung cancer across racial/ethnic groups, discuss differences in smoking patterns and use of evidence-based smoking cessation, and describe emerging disparities in lung cancer screening. The course will also offer resources for providers to address common barriers to screening among underserved/underrepresented groups, including insurance information, transportation options, procedure time, and patient navigation assistance.
Lesson 1 of the LuCa online course addresses lung cancer screening and shared decision making.
| Study group | Role | What they receive |
|---|---|---|
| LuCa + Health Disparity module | Experimental | Participants will be asked to complete the Health Disparities module that is an interactive CME/CE online course which offers 0.5 continuing education credit hours.
The will also be asked to complete the LuCa course. Receives: Behavioral: LuCa + Health Disparity module |
| LuCa only module | Active comparator | LuCa is a free interactive CME/CE online course entitled, "Lung Cancer and the Primary Care Provider". For the purpose of this study, participants will be asked to complete session 1 which offers 1.0 continuing education credit hours, including AMA PRA Category 1 credits, AANP, and AAFP Prescribed credits. Receives: Behavioral: LuCa + Health Disparity module |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of providers with improved mean lung cancer screening knowledge score
Knowledge about lung cancer screening
Measured: 1 week
Number of providers with improved mean attitudes score
Attitudes about lung cancer screening
Measured: 1 week
Secondary outcomes (1)
Rate of lung cancer screening referrals
Lung cancer screening referrals from the electronic health record
Measured: 2 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start27 Oct 2021
- Primary completion28 Feb 2022
- Study completion27 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Arm 1- LuCa + Health Disparity module: Providers enrolled in the LuCa+ arm will complete lesson 1 of the LuCa training and complete the Health Disparity module. Arm 2- LuCa module: Providers enrolled in the LuCa arm will complete session 1 of the LuCa training.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064046
- Sponsor's protocol ID
- STUDY00003967
- Other IDs
- 3R01CA207228-05S1
- Status last verified
- Nov 2021
- First submitted
- 29 Sep 2021
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith L, Williams RM, Whealan J, Windels A, Anderson ED, Parikh V, Breece CJ, Puran N, Shepherd AK, Geronimo M, Luta G, Adams-Campbell L, Taylor KL. Development and Evaluation of Brief Web-Based Education for Primary Care Providers to Address Inequities in Lung Cancer Screening and Smoking Cessation Treatment. J Cancer Educ. 2023 Aug;38(4):1296-1303. doi: 10.1007/s13187-023-02262-3. Epub 2023 Jan 13.
PubMed 36637713
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educating Providers About Health Disparities in Lung Cancer Screening
- ClinicalTrials.gov ID
- NCT05064046
- Acronym / sponsor ID
- STUDY00003967
- Conditions
- Lung Cancer
- Keywords
- lung cancer screening, provider education, health disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We are conducting a randomized trial to compare the Health Disparities module to an existing provider module on lung cancer screening to evaluate the impact on primary care providers' knowledge, attitudes, and lung cancer screening referrals of African American and White patients.
Detailed description
We are conducting a randomized trial of two online, provider-facing education modules regarding lung cancer screening and smoking cessation. We will accrue 70 MedStar primary care providers (PCP). The baseline survey will incorporate items regarding lung cancer screening knowledge, providers' attitudes towards lung cancer screening, lung cancer screening ordering practices and provider characteristics. At the end of the baseline survey, PCPs will be randomly assigned to the LuCa + Health Disparities or LuCa only. PCPs will be asked to complete the intervention and the post-test within 1 week of randomization. The post test will cover knowledge of lung cancer screening, attitudes and opinions toward LCS. To assess PCP lung cancer screening ordering practices, we will review the MedConnect Electronic Health Record (EHR) to compare the two study groups post-randomization on the number of orders made for LCS.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Arm 1- LuCa + Health Disparity module: Providers enrolled in the LuCa+ arm will complete lesson 1 of the LuCa training and complete the Health Disparity module. Arm 2- LuCa module: Providers enrolled in the LuCa arm will complete session 1 of the LuCa training.
| Arm | Type | Receives |
|---|---|---|
| LuCa + Health Disparity module | Experimental | Behavioral: LuCa + Health Disparity moduleParticipants will be asked to complete the Health Disparities module that is an interactive CME/CE online course which offers 0.5 continuing education credit hours. The will also be asked to complete the LuCa course. |
| LuCa only module | Active comparator | Behavioral: LuCa + Health Disparity moduleLuCa is a free interactive CME/CE online course entitled, "Lung Cancer and the Primary Care Provider". For the purpose of this study, participants will be asked to complete session 1 which offers 1.0 continuing education credit hours, including AMA PRA Category 1 credits, AANP, and AAFP Prescribed credits. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- MedStar provider (attending or resident physician, physician's assistant, or nurse practitioner)
- English speaking
- ability to provide meaningful consent
- ability to provide last two digits of NPI.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LuCa + Health Disparity moduleThe Health Disparity course will review disparities in the burden of lung cancer across racial/ethnic groups, discuss differences in smoking patterns and use of evidence-based smoking cessation, and describe emerging disparities in lung cancer screening. The course will also offer resources for providers to address common barriers to screening among underserved/underrepresented groups, including insurance information, transportation options, procedure time, and patient navigation assistance. Lesson 1 of the LuCa online course addresses lung cancer screening and shared decision making. | Behavioural | LuCa + Health Disparity module, LuCa only module |
Primary outcome
Number of providers with improved mean lung cancer screening knowledge score
Time frame: 1 week
Knowledge about lung cancer screening
Number of providers with improved mean attitudes score
Time frame: 1 week
Attitudes about lung cancer screening
1 secondary outcome
Rate of lung cancer screening referrals
Time frame: 2 months post-randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Derived from this study: PubMed 36637713Smith L, Williams RM, Whealan J, Windels A, Anderson ED, Parikh V, Breece CJ, Puran N, Shepherd AK, Geronimo M, Luta G, Adams-Campbell L, Taylor KL. Development and Evaluation of Brief Web-Based Education for Primary Care Providers to Address Inequities in Lung Cancer Screening and Smoking Cessation Treatment. J Cancer Educ. 2023 Aug;38(4):1296-1303. doi: 10.1007/s13187-023-02262-3. Epub 2023 Jan 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LuCa + Health Disparity module in people with Lung Cancer, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of providers with improved mean lung cancer screening knowledge score (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05064046, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.