Screening ComplianceNCT07287085
Increasing Lung Cancer Screening Uptake Among Emergency Department Patients
A study testing Facilitated referral and text messaging in people with Screening Compliance and Lung Cancer (Diagnosis), run by University of Rochester at 1 site in United States.
Trial summary
The objective of the proposed clinical trial is to determine if we can increase LCS among ED patients using a combination of facilitated referral to an LCS program plus text message reminders to get screened. Step 1 of the approach is to identify participants that are eligible for LCS. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Screening Compliance, Lung Cancer (Diagnosis), Lung Cancer Diagnosis
- What is being tested?
- Facilitated referral and text messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 349 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2026to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50 - 80
- ≥ 20 pack-year smoking history
- current smoker or quit within 15 years
- English speaking
- Current patient in URMC involved Emergency Department
Who cannot join
- Non-English
- Inability to provide consent (e.g. high clinical acuity, cognitive deficit)
- Lack of text-capable mobile phone and/or inability to use text function
- Not being a patient in URMC involved Emergency Department There are no restrictions for gender, racial and ethnic origins.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester
Rochester, New York, 14642
Peter MacDowell, 585-274-1509, peter_macdowell@urmc.rochester.edu
Nancy Wood
About this study
The objective of the proposed clinical trial is to determine if we can increase LCS among ED patients using a combination of facilitated referral to an LCS program plus text message reminders to get screened. Step 1 of the approach is to identify participants that are eligible for LCS. Step 2 is to randomize eligible study participants between two study arms: (1) basic referral for LCS (i.e.
verbal referral with written materials), and (2) facilitated referral for LCS (i.e. submission of a requisition to LCS program by staff) plus a subsequent series of text messages aimed at generating intention and motivation to get screened. The investigators' preliminary work showed this approach was feasible in the ED setting. The proposed study will build on this preliminary work with the goal of having a significant positive impact on LCS uptake.
A total of 300 individuals eligible for LCS will be recruited from a high-volume urban ED, randomized between study arms, and followed-up at 120 days to assess interval LCS uptake. The Specific Aims of the proposed project are, (1) Compare LCS uptake between the two study arms, (2) Identify predictors of individuals that are not up-to-date with LCS at the time of enrollment, and (3) Evaluate study participant feedback on (a) barriers and facilitators to getting screened and (b) acceptability and appropriateness of ED-based promotion of LCS. The study team is at the forefront of developing ED-based interventions to promote cancer screening. This project leverages the universal access setting of the ED to identify individuals at greatest risk for lung cancer and get them screened. A scalable ED-based intervention that increases LCS uptake would save lives.
- Being tested
- Facilitated referral and text messaging, Basic Referral (enhanced control arm)
- Keywords
- screening, lung cancer, screening compliance
- Medical subject headings
- Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitated referral and text messagingBehavioural
Participants randomized to the experimental arm will be instructed that the LCS program will reach out to them to discuss LCS and, if decided upon, schedule screening. An LCS Program Navigator will call the participant by phone, conduct a shared decision-making discussion, and schedule the screening CT scan (assuming eligibility is confirmed and the discussion results in the participant's decision to schedule screening). In addition, participants in Arm 2 will receive a series of text messages, grounded in the TPB, SDT, and HBM aimed at generating intention and motivation to get LCS.
Basic Referral (enhanced control arm)Behavioural
They will also be provided with written materials that include telephone contact information for the LCS Program Navigator. If contacted, the LCS Program Navigator will conduct a shared decision-making (SDM) discussion, schedule the screening CT scan at one of the 8 regional American College of Radiology-designated LCS centers and arrange follow-up as needed. Since determination of LCS needs is not routine during an ED visit, this "control arm" reflects an enhancement over usual care. It would not be ethical to identify a patient with screening needs without providing a referral.
| Study group | Role | What they receive |
|---|---|---|
| Basic Referral (enhanced control arm) | Active comparator | Participants assigned to Arm 1 will be referred to the UR Medicine LCS Program and their primary care provider (if they have one) to discuss LCS. They will also be provided with written materials that include telephone contact information for the LCS Program Navigator. Receives: Behavioral: Basic Referral (enhanced control arm) |
| Facilitated Referral + Text Messaging | Experimental | For participants assigned to Arm 2, an LCS requisition form will be submitted to the UR Medicine LCS Program on behalf of the participant during their ED visit. The participant's primary care provider (if they have one) will be CC'd on the requisition. Participants will be instructed that the LCS program will reach out to them to discuss LCS and, if decided upon, schedule screening. An LCS Program Navigator will call the participant by phone, conduct a shared decision-making discussion, and schedule the screening CT scan (assuming eligibility is confirmed and the discussion results in the participant's decision to schedule screening). In addition, participants in Arm 2 will receive a series of text messages, grounded in the TPB, SDT, and HBM aimed at generating intention and motivation to get LCS. Receives: Behavioral: Facilitated referral and text messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment for LCS Uptake and Downstream Care
The primary outcome, LCS uptake, will be assessed via telephone follow-up and EHR review.
Measured: From enrollment through participation with first assessment at ~ 120 days of participation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start18 Mar 2026
- Primary completionMar 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Screening ComplianceStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 349 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Lung Cancer Research Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287085
- Sponsor's protocol ID
- FP 9214
- Status last verified
- Apr 2026
- First submitted
- 2 Dec 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Lung Cancer Screening Uptake Among Emergency Department Patients
- ClinicalTrials.gov ID
- NCT07287085
- Acronym / sponsor ID
- FP 9214
- Keywords
- screening, lung cancer, screening compliance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 349 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Lung Cancer Research Foundation
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 17 Dec 2025 (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 objective of the proposed clinical trial is to determine if we can increase LCS among ED patients using a combination of facilitated referral to an LCS program plus text message reminders to get screened. Step 1 of the approach is to identify participants that are eligible for LCS. Step 2 is to randomize eligible study participants between two study arms: (1) basic referral for LCS (i.e.
verbal referral with written materials), and (2) facilitated referral for LCS (i.e. submission of a requisition to LCS program by staff) plus a subsequent series of text messages aimed at generating intention and motivation to get screened. The investigators' preliminary work showed this approach was feasible in the ED setting. The proposed study will build on this preliminary work with the goal of having a significant positive impact on LCS uptake.
A total of 300 individuals eligible for LCS will be recruited from a high-volume urban ED, randomized between study arms, and followed-up at 120 days to assess interval LCS uptake. The Specific Aims of the proposed project are, (1) Compare LCS uptake between the two study arms, (2) Identify predictors of individuals that are not up-to-date with LCS at the time of enrollment, and (3) Evaluate study participant feedback on (a) barriers and facilitators to getting screened and (b) acceptability and appropriateness of ED-based promotion of LCS. The study team is at the forefront of developing ED-based interventions to promote cancer screening. This project leverages the universal access setting of the ED to identify individuals at greatest risk for lung cancer and get them screened. A scalable ED-based intervention that increases LCS uptake would save lives.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Basic Referral (enhanced control arm) | Active comparator | Behavioral: Basic Referral (enhanced control arm)Participants assigned to Arm 1 will be referred to the UR Medicine LCS Program and their primary care provider (if they have one) to discuss LCS. They will also be provided with written materials that include telephone contact information for the LCS Program Navigator. |
| Facilitated Referral + Text Messaging | Experimental | Behavioral: Facilitated referral and text messagingFor participants assigned to Arm 2, an LCS requisition form will be submitted to the UR Medicine LCS Program on behalf of the participant during their ED visit. The participant's primary care provider (if they have one) will be CC'd on the requisition. Participants will be instructed that the LCS program will reach out to them to discuss LCS and, if decided upon, schedule screening. An LCS Program Navigator will call the participant by phone, conduct a shared decision-making discussion, and schedule the screening CT scan (assuming eligibility is confirmed and the discussion results in the participant's decision to schedule screening). In addition, participants in Arm 2 will receive a series of text messages, grounded in the TPB, SDT, and HBM aimed at generating intention and motivation to get LCS. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 50 - 80
- ≥ 20 pack-year smoking history
- current smoker or quit within 15 years
- English speaking
- Current patient in URMC involved Emergency Department
Key exclusion criteria (4 listed)
- Non-English
- Inability to provide consent (e.g. high clinical acuity, cognitive deficit)
- Lack of text-capable mobile phone and/or inability to use text function
- Not being a patient in URMC involved Emergency Department There are no restrictions for gender, racial and ethnic origins.
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 |
|---|---|---|
| Facilitated referral and text messagingParticipants randomized to the experimental arm will be instructed that the LCS program will reach out to them to discuss LCS and, if decided upon, schedule screening. An LCS Program Navigator will call the participant by phone, conduct a shared decision-making discussion, and schedule the screening CT scan (assuming eligibility is confirmed and the discussion results in the participant's decision to schedule screening). In addition, participants in Arm 2 will receive a series of text messages, grounded in the TPB, SDT, and HBM aimed at generating intention and motivation to get LCS. | Behavioural | Facilitated Referral + Text Messaging |
| Basic Referral (enhanced control arm)They will also be provided with written materials that include telephone contact information for the LCS Program Navigator. If contacted, the LCS Program Navigator will conduct a shared decision-making (SDM) discussion, schedule the screening CT scan at one of the 8 regional American College of Radiology-designated LCS centers and arrange follow-up as needed. Since determination of LCS needs is not routine during an ED visit, this "control arm" reflects an enhancement over usual care. It would not be ethical to identify a patient with screening needs without providing a referral. | Behavioural | Basic Referral (enhanced control arm) |
Primary outcome
Assessment for LCS Uptake and Downstream Care
Time frame: From enrollment through participation with first assessment at ~ 120 days of participation.
The primary outcome, LCS uptake, will be assessed via telephone follow-up and EHR review.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facilitated referral and text messaging in people with Screening Compliance and Lung Cancer (Diagnosis), run by University of Rochester 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 4 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter MacDowell (585-274-1509, peter_macdowell@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment for LCS Uptake and Downstream Care (time frame: From enrollment through participation with first assessment at ~ 120 days of participation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2026.