Lung Cancer ScreeningI-STEPNCT03958253
Lung Cancer Screening Protocol
A study testing Toolbox for Lung Cancer Screening in people with Lung Cancer Screening, run by Washington University School of Medicine at 7 sites in United States.
Trial summary
The successful implementation of lung cancer screening across diverse setting requires working with the community and primary care practices. Collaborating across diverse community-based sites will employ local knowledge and culture in the understanding of the health problem and identifying and implementing solutions… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer Screening
- What is being tested?
- Toolbox for Lung Cancer Screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 7 sitesUnited States
- Study dates
- 22 Apr 2019to 31 Mar 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be eligible to participate in the trial, screening centers have to be existing members of the BJC Collaborative.
- Primary Care Providers have to have a referral relationship with the screening center; serve adult patients who may be screening-eligible, and are willing to interact with the referral site to implement referral for LDCT.
Who cannot join
- There are not any exclusion criteria for the study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Southern Illinois Healthcare
Carbondale, Illinois, 62901
BJC HealthCare, Barnes-Jewish St. Peters Hospital
City of Saint Peters, Missouri, 63376
Decatur Memorial Hospital
Decatur, Illinois, 62526
Sarah Bush Lincoln Health System
Mattoon, Illinois, 61938
Memorial Health System
Springfield, Illinois, 62702
CoxHealth
Springfield, Missouri, 65802
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: I-STEP: Increasing Screening Through Engaging Primary Care Providers
The successful implementation of lung cancer screening across diverse setting requires working with the community and primary care practices. Collaborating across diverse community-based sites will employ local knowledge and culture in the understanding of the health problem and identifying and implementing solutions that are appropriate for all partners (patients, primary care, referral centers). Enhanced, culturally-competent communication with patients at high risk for lung cancer can narrow inequities in screening awareness, referral, and utilization, as well as improve lung cancer outcomes across diverse patients and communities. Promoting partnerships among physicians, staff, and patients; creating routines; and tailoring materials to each clinician's situation have been show to increase the proportion of patients receiving screening.
- Conditions
- Lung Cancer Screening
- Being tested
- Toolbox for Lung Cancer Screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toolbox for Lung Cancer ScreeningOther
-Toolbox of evidence-based elements that a primary care or referral site could implement to address known barriers to screening and referral, as well as required elements for screening. These elements will be designed to be adaptable to the unique needs and screening processes of the participating practices.
- Patient education materials
- Primary care practice educational materials
- Pack-years/eligibility calculator
- Local referral process guide
- Smoking cessation materials and support
- Shared decision-making guide
- LDCT best practice guidelines
| Study group | Role | What they receive |
|---|---|---|
| Lung Cancer Screening Toolbox | Experimental | * WU Staff will train local screening staff using a train-the-trainer model three months prior to the intervention and will provide technical assistance on an ongoing basis.
* During the 3 hour train-the-trainer session, the selected staff from the referral sites will learn about the program, receive an orientation to the toolbox elements, and discuss how to adapt the elements of the toolbox to their referral sites. Receives: Other: Toolbox for Lung Cancer Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of initial low-dose CT (LDCT) scan screenings per month per screening center
-Screening will be defined as completed initial screen for lung cancer
Measured: Completion of study (estimated to be 21 months)
Secondary outcomes (3)
Number of primary care providers who refer at least two patients per month for LDCT
Measured: Completion of study (estimated to be 21 months)
Percent of patients referred who are screen-eligible
Defined as the number of screen-eligible patients divided by the total of screening procedures performed
Measured: Completion of study (estimated to be 21 months)
Percent of patients referred who complete screening
Defined as the number of patients referred for screening divided by the total number of screening procedures performed.
Measured: Completion of study (estimated to be 21 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start22 Apr 2019
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
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 Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Sequential
- Model description
- This is a stepped wedge cluster randomized trial in which the intervention condition (toolbox) is sequentially assigned to participating hospitals (screening centers) in 6 clusters at different time-delays and where pre-intervention data serves as the control. By the end of the study, all clusters have been exposed to the intervention and each cluster has provided data for the control and intervention conditions. Independent samples of primary care providers are enrolled at each period within a cluster, thus, it is a repeated cross-sectional study. The order of the entry into the intervention phase is randomized based on levels of readiness
- Masking
- None (open label)
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- BJC HealthCare, Barnes-Jewish St. Peters Hospital, Decatur Memorial Hospital, Memorial Health System, Sarah Bush Lincoln Health System, Southern Illinois Healthcare, Cox Health Systems
- Responsible party
- Sponsor
- Investigators
- Aimee S James, Ph.D., MPH, Principal investigator, Washington University School of MedicineGraham A Colditz, M.D., DrPH, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958253
- Sponsor's protocol ID
- 201811093
- Acronym
- I-STEP
- Status last verified
- Apr 2021
- First submitted
- 17 May 2019
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Practice level and screening center aggregate numbers may be made available to investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose
Publications
Salazar AS, Sekhon S, Rohatgi KW, Nuako A, Liu J, Harriss C, Brennan E, LaBeau D, Abdalla I, Schulze C, Muenks J, Overlot D, Higgins JA, Jones LS, Swick C, Goings S, Badiu J, Walker J, Colditz GA, James AS. A stepped-wedge randomized trial protocol of a community intervention for increasing lung screening through engaging primary care providers (I-STEP). Contemp Clin Trials. 2020 Apr;91:105991. doi: 10.1016/j.cct.2020.105991. Epub 2020 Mar 14.
PubMed 32184197
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I-STEP: Increasing Screening Through Engaging Primary Care Providers
- ClinicalTrials.gov ID
- NCT03958253
- Acronym / sponsor ID
- I-STEP / 201811093
- Conditions
- Lung Cancer Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- BJC HealthCare, Barnes-Jewish St. Peters Hospital, Decatur Memorial Hospital, Memorial Health System, Sarah Bush Lincoln Health System, Southern Illinois Healthcare, Cox Health Systems
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 21 May 2019 (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.
The successful implementation of lung cancer screening across diverse setting requires working with the community and primary care practices. Collaborating across diverse community-based sites will employ local knowledge and culture in the understanding of the health problem and identifying and implementing solutions that are appropriate for all partners (patients, primary care, referral centers). Enhanced, culturally-competent communication with patients at high risk for lung cancer can narrow inequities in screening awareness, referral, and utilization, as well as improve lung cancer outcomes across diverse patients and communities. Promoting partnerships among physicians, staff, and patients; creating routines; and tailoring materials to each clinician's situation have been show to increase the proportion of patients receiving screening.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a stepped wedge cluster randomized trial in which the intervention condition (toolbox) is sequentially assigned to participating hospitals (screening centers) in 6 clusters at different time-delays and where pre-intervention data serves as the control. By the end of the study, all clusters have been exposed to the intervention and each cluster has provided data for the control and intervention conditions. Independent samples of primary care providers are enrolled at each period within a cluster, thus, it is a repeated cross-sectional study. The order of the entry into the intervention phase is randomized based on levels of readiness
| Arm | Type | Receives |
|---|---|---|
| Lung Cancer Screening Toolbox | Experimental | Other: Toolbox for Lung Cancer Screening* WU Staff will train local screening staff using a train-the-trainer model three months prior to the intervention and will provide technical assistance on an ongoing basis. * During the 3 hour train-the-trainer session, the selected staff from the referral sites will learn about the program, receive an orientation to the toolbox elements, and discuss how to adapt the elements of the toolbox to their referral sites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- To be eligible to participate in the trial, screening centers have to be existing members of the BJC Collaborative.
- Primary Care Providers have to have a referral relationship with the screening center; serve adult patients who may be screening-eligible, and are willing to interact with the referral site to implement referral for LDCT.
Key exclusion criteria (1 listed)
- There are not any exclusion criteria for the study
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 |
|---|---|---|
| Toolbox for Lung Cancer Screening-Toolbox of evidence-based elements that a primary care or referral site could implement to address known barriers to screening and referral, as well as required elements for screening. These elements will be designed to be adaptable to the unique needs and screening processes of the participating practices. * Patient education materials * Primary care practice educational materials * Pack-years/eligibility calculator * Local referral process guide * Smoking cessation materials and support * Shared decision-making guide * LDCT best practice guidelines | Other | Lung Cancer Screening Toolbox |
Primary outcome
Number of initial low-dose CT (LDCT) scan screenings per month per screening center
Time frame: Completion of study (estimated to be 21 months)
-Screening will be defined as completed initial screen for lung cancer
3 secondary outcomes
Number of primary care providers who refer at least two patients per month for LDCT
Time frame: Completion of study (estimated to be 21 months)
Percent of patients referred who are screen-eligible
Time frame: Completion of study (estimated to be 21 months)
Percent of patients referred who complete screening
Time frame: Completion of study (estimated to be 21 months)
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 8 Apr 2021.
- Derived from this study: PubMed 32184197Salazar AS, Sekhon S, Rohatgi KW, Nuako A, Liu J, Harriss C, Brennan E, LaBeau D, Abdalla I, Schulze C, Muenks J, Overlot D, Higgins JA, Jones LS, Swick C, Goings S, Badiu J, Walker J, Colditz GA, James AS. A stepped-wedge randomized trial protocol of a community intervention for increasing lung screening through engaging primary care providers (I-STEP). Contemp Clin Trials. 2020 Apr;91:105991. doi: 10.1016/j.cct.2020.105991. Epub 2020 Mar 14.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Practice level and screening center aggregate numbers may be made available to investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose
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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.
Aimee S James, Ph.D., MPH principal investigator
Washington University School of Medicine
Graham A Colditz, M.D., DrPH principal investigator
Washington University School of Medicine
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toolbox for Lung Cancer Screening in people with Lung Cancer Screening, run by Washington University School of Medicine at 7 sites 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 2 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 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 initial low-dose CT (LDCT) scan screenings per month per screening center (time frame: Completion of study (estimated to be 21 months)). 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 NCT03958253, 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 8 Apr 2021.