Lung CancerNCT05832008
Increasing Adherence to Lung Cancer Screening
A study testing Patient Nudge and Clinician Nudge in people with Lung Cancer and Adherence, Patient, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
Investigators are conducting a pragmatic randomized trial testing the effectiveness of patient and clinician nudge strategies on adherence to lung cancer screening (LCS) \& diagnostic follow-up across eligible primary care clinicians \& patients. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Lung Cancer, Adherence, Patient
- What is being tested?
- Patient Nudge and Clinician Nudge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 825 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2023to 28 Feb 2026
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinicians will be eligible if they:
- are practicing primary care or specialty care physicians at a recruiting site within the University of Pennsylvania Health System;
- care for patients who completed LCS via LDCT in 2019-2023; and
- do not opt-out of study participation.
- Patients will be eligible if they:
- are eligible for LCS based on 2021 US Preventive Services Task Force (USPSTF) population guidelines (aged 50-80; smoking history of 20-pack years; smoked within the last 15 years)
Show all 11Show fewer
- completed LCS via LDCT in 2019-2023;
- have not been diagnosed with lung cancer at the time of randomization;
- meet criteria for non-adherence;
- remain eligible for LCS during the trial enrollment period; and
- receive LCS care from a clinician that has not opted-out of study participation
Who cannot join
- Patients will be excluded if they:
- have a highly suspicious baseline LDCT (Lung-RADS 4B/X) given the presence of existing clinical pathways to ensure adherence in this group
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Increasing Equitable Adherence to Annual Lung Cancer Screening and Diagnostic Follow-up
Investigators are conducting a pragmatic randomized trial testing the effectiveness of patient and clinician nudge strategies on adherence to lung cancer screening (LCS) \& diagnostic follow-up across eligible primary care clinicians \& patients. Following the trial, a subsample of patients \& clinicians will be invited to one-time semi-structured interview \& survey to identify individual \& system-level factors that may restrict or enhance the impact of strategies.
Read the detailed description
Investigators will conduct a pragmatic clinical trial with a 2 x 2 factorial design with clinicians that provide care to screening-eligible patients who are overdue for annual screening or diagnostic evaluation. The specific nudge strategies to be tested are: 1) gain-framed messaging delivered via text messaging to prompt patient adherence to LCS guidelines (patient nudges); and 2) electronic health record (EHR) prompts alerting clinicians when their patients are due for annual screening or diagnostic follow-up (clinician nudges). The rationale for this study is that changing external stimuli to encourage adherence to evidence-based LCS guidelines will increase early detection of lung cancer by removing individual and system-level barriers to identifying and prompting patients who are due for care. The central hypothesis is that the combination of patient and clinician strategies will have the greatest effect on increasing adherence because it will target multilevel determinants of lung cancer screening identified in our prior research including limited screening knowledge and suboptimal EHR design. The proposed strategies are designed to support equitable implementation across diverse settings and populations.
- Conditions
- Lung Cancer, Adherence, Patient
- Being tested
- Patient Nudge, Clinician Nudge
- Keywords
- Screening, Nudge, Adherence, Implementation science, Behavioral science, Digital health
- Medical subject headings
- Lung Neoplasms, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient NudgeBehavioural
Brief persuasive messaging to increase awareness about the importance of annual lung cancer screening and completion of recommended follow-up sent to patients via text message.
Clinician NudgeBehavioural
EHR-based Prompts - an pended order and message that alerts a clinician if a patient is due for screening or diagnostic follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Clinician Nudge + Patient Nudge | Experimental | An EHR-prompt (pended order) will prompt clinicians in this arm when a patient is due for lung cancer screening or diagnostic follow-up.
Patients in this arm will receive messaging designed to increase awareness about the importance of annual screening and recommended follow-up Receives: Behavioral: Patient Nudge; Behavioral: Clinician Nudge |
| Clinician Nudge Only | Experimental | Clinicians in this arm will be prompted by a pended order when a patient is due for lung cancer screening or diagnostic follow-up.
Patients will receive usual care. Receives: Behavioral: Clinician Nudge |
| Patient Nudge Only | Experimental | Patients in this arm will receive messaging designed to increase awareness about the importance of annual screening and recommended follow-up.
Clinicians will receive usual care. Receives: Behavioral: Patient Nudge |
| Usual care (no nudges) | No intervention | Patients and clinicians in this arm will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
The primary outcome is adherence defined as timely completion of recommended scan (annual LDCT or diagnostic follow-up scan) based on clinical guidelines.
Measured: Initial measurement will occur 3 months after randomization
Secondary outcomes (1)
Reach
Reach defined by proportion of patients who receive patient nudges (i.e., text message) among those sent and by the proportion of patients whose clinician acts upon clinician nudge (i.e., signs pended orders) among those sent.
Measured: Initial measurement will occur 3 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start18 Oct 2023
- Primary completion31 Aug 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- At the start of the trial, clinicians who do not opt-out will be randomized to the intervention (clinician nudge) or control arm (no clinician nudge). Eligible patients will be randomized, stratified by clinician, to either the intervention (patient nudge) or control group (no patient nudge).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 825 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network, AstraZeneca
- Responsible party
- Principal investigator, Katharine Rendle, Abramson Cancer Center at Penn Medicine
- Investigators
- Katharine Rendle, PhD,MSW,MPH, Principal investigator, University of PennsylvaniaAnil Vachani, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832008
- Sponsor's protocol ID
- UPCC 09522
- Other IDs
- 851056
- Status last verified
- Oct 2026
- First submitted
- 23 Mar 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Equitable Adherence to Annual Lung Cancer Screening and Diagnostic Follow-up
- ClinicalTrials.gov ID
- NCT05832008
- Acronym / sponsor ID
- UPCC 09522
- Conditions
- Lung Cancer, Adherence, Patient
- Keywords
- Screening, Nudge, Adherence, Implementation science, Behavioral science, Digital health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 825 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network, AstraZeneca
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 27 Apr 2023 (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.
Investigators are conducting a pragmatic randomized trial testing the effectiveness of patient and clinician nudge strategies on adherence to lung cancer screening (LCS) \& diagnostic follow-up across eligible primary care clinicians \& patients. Following the trial, a subsample of patients \& clinicians will be invited to one-time semi-structured interview \& survey to identify individual \& system-level factors that may restrict or enhance the impact of strategies.
Detailed description
Investigators will conduct a pragmatic clinical trial with a 2 x 2 factorial design with clinicians that provide care to screening-eligible patients who are overdue for annual screening or diagnostic evaluation. The specific nudge strategies to be tested are: 1) gain-framed messaging delivered via text messaging to prompt patient adherence to LCS guidelines (patient nudges); and 2) electronic health record (EHR) prompts alerting clinicians when their patients are due for annual screening or diagnostic follow-up (clinician nudges). The rationale for this study is that changing external stimuli to encourage adherence to evidence-based LCS guidelines will increase early detection of lung cancer by removing individual and system-level barriers to identifying and prompting patients who are due for care. The central hypothesis is that the combination of patient and clinician strategies will have the greatest effect on increasing adherence because it will target multilevel determinants of lung cancer screening identified in our prior research including limited screening knowledge and suboptimal EHR design. The proposed strategies are designed to support equitable implementation across diverse settings and populations.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- At the start of the trial, clinicians who do not opt-out will be randomized to the intervention (clinician nudge) or control arm (no clinician nudge). Eligible patients will be randomized, stratified by clinician, to either the intervention (patient nudge) or control group (no patient nudge).
| Arm | Type | Receives |
|---|---|---|
| Clinician Nudge + Patient Nudge | Experimental | Behavioral: Patient Nudge, Behavioral: Clinician NudgeAn EHR-prompt (pended order) will prompt clinicians in this arm when a patient is due for lung cancer screening or diagnostic follow-up. Patients in this arm will receive messaging designed to increase awareness about the importance of annual screening and recommended follow-up |
| Clinician Nudge Only | Experimental | Behavioral: Clinician NudgeClinicians in this arm will be prompted by a pended order when a patient is due for lung cancer screening or diagnostic follow-up. Patients will receive usual care. |
| Patient Nudge Only | Experimental | Behavioral: Patient NudgePatients in this arm will receive messaging designed to increase awareness about the importance of annual screening and recommended follow-up. Clinicians will receive usual care. |
| Usual care (no nudges) | No intervention | –Patients and clinicians in this arm will receive usual care. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- are practicing primary care or specialty care physicians at a recruiting site within the University of Pennsylvania Health System;
- care for patients who completed LCS via LDCT in 2019-2023; and
- do not opt-out of study participation.
- are eligible for LCS based on 2021 US Preventive Services Task Force (USPSTF) population guidelines (aged 50-80; smoking history of 20-pack years; smoked within the last 15 years)
- completed LCS via LDCT in 2019-2023;
Key exclusion criteria (2 listed)
- have a highly suspicious baseline LDCT (Lung-RADS 4B/X) given the presence of existing clinical pathways to ensure adherence in this group
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 |
|---|---|---|
| Patient NudgeBrief persuasive messaging to increase awareness about the importance of annual lung cancer screening and completion of recommended follow-up sent to patients via text message. | Behavioural | Clinician Nudge + Patient Nudge, Patient Nudge Only |
| Clinician NudgeEHR-based Prompts - an pended order and message that alerts a clinician if a patient is due for screening or diagnostic follow-up. | Behavioural | Clinician Nudge + Patient Nudge, Clinician Nudge Only |
Primary outcome
Adherence
Time frame: Initial measurement will occur 3 months after randomization
The primary outcome is adherence defined as timely completion of recommended scan (annual LDCT or diagnostic follow-up scan) based on clinical guidelines.
1 secondary outcome
Reach
Time frame: Initial measurement will occur 3 months after 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 21 Oct 2026.
- 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.
Katharine Rendle, PhD,MSW,MPH principal investigator
University of Pennsylvania
Anil Vachani, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Nudge and Clinician Nudge in people with Lung Cancer and Adherence, Patient, run by Abramson Cancer Center at Penn Medicine 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 11 inclusion and 2 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 21 Oct 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?
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?
Adherence (time frame: Initial measurement will occur 3 months after randomization). 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 21 Oct 2026.