Early Detection of CancerITALCSNCT06638554
Integrating Telehealth to Advance Lung Cancer Screening
A study testing Active Choice, Telehealth Only and Low Touch Strategy in people with Early Detection of Cancer and Telemedicine, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
The goal of this pragmatic trial is to learn if telehealth strategies can increase shared decision-making (SDM) for lung cancer screening (LCS). It will also learn about the equity of these strategies by conducting non-inferiority analysis by race and sex. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Early Detection of Cancer, Telemedicine, Decision Making
- What is being tested?
- Active Choice, Telehealth Only and Low Touch Strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2024to 30 Jun 2027
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be eligible if:
- are aged 50 to 80
- have a history of tobacco use indicated by either: Documented 20 pack-year or greater smoking history in their electronic health record (EHR); OR Self-report via structured survey
- currently smoke or formerly smoked cigarettes
- have no documented history of lung cancer
- have no documented history of lung cancer screening in the 24 months prior to study enrollment
- have completed at least one primary care visit at Penn Medicine in the 3 years prior to study enrollment.
Who cannot join
- Participants who do not meet inclusion criteria will not be eligible.
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 Pennsylvania
Philadelphia, Pennsylvania, 19104
Katharine Rendle, PhD,MSW,MPH, 215-349- 5442, katharine.rendle@pennmedicine.upenn.edu
Hannah Toneff, MSW, MA, 267-882-3186, Hannah.Toneff@pennmedicine.upenn.edu
About this study
The goal of this pragmatic trial is to learn if telehealth strategies can increase shared decision-making (SDM) for lung cancer screening (LCS). It will also learn about the equity of these strategies by conducting non-inferiority analysis by race and sex. The main questions it aims to answer are:
- Does patient outreach using synchronous and asynchronous telehealth strategies increase completion of SDM visits for LCS?
- Is the effectiveness of these telehealth strategies similar by race and sex?
The study uses a Sequential Multiple Assignment Randomized Trial (SMART) design and includes two stages of interventions. The first stage of intervention includes direct patient outreach with an invitation to schedule either a 1) telehealth SDM visit or 2) telehealth or in-person SDM visit. Participants that do not respond to the first stage interventions receive a text message reminder encouraging SDM visit completion with or without digital care coordination.
Read the detailed description
Annual lung cancer screening using low-dose computed tomography (LDCT) is associated with decreased lung cancer mortality but also with harms. As such, it is recommended, and required for reimbursement, that patients complete an shared decision-making visit (SDM) prior to screening to discuss potential risks and benefits in the context of patient values. Despite guidelines recommending screening and national insurance coverage of LDCT, uptake of SDM visits and subsequent LDCT is remarkably low. We aim to address these gaps by comparing the effectiveness of synchronous and asynchronous telehealth strategies on SDM visits and subsequent LDCT in a pragmatic trial using a Sequential Multiple Assignment Randomized Trial (SMART) design. The specific first stage strategies to be tested are: a) Active Choice Outreach (invitation to schedule a telehealth or in-person SDM visit) vs b) Telehealth Only Outreach (invitation to schedule a telehealth SDM visit). The specific second stage strategies (delivered only if participants do not respond to first stage interventions) are a) text message reminders encouraging SDM visit completion (low-touch) alone or b) in combination with phone-based digital care coordination (high-touch). We will also assess non-inferiority of strategies by race and sex to assess equity of effectiveness.
- Conditions
- Early Detection of Cancer, Telemedicine, Decision Making
- Being tested
- Active Choice, Telehealth Only, Low Touch Strategy, High Touch Strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active ChoiceBehavioural
The participant will be send a letter inviting them to complete a SDM visit either in-person or via telehealth.
Telehealth OnlyBehavioural
The participant will be send a letter inviting them to complete a SDM visit via telehealth only.
Low Touch StrategyBehavioural
Patient will be sent asynchronous text messaging reminders encouraging SDM for LCS using framed messaging.
High Touch StrategyBehavioural
Patient will be sent asynchronous text messaging reminders encouraging SDM for LCS using framed messaging in combination with synchronous telephone-based digital care coordination.
| Study group | Role | What they receive |
|---|---|---|
| Active Choice (Stage 1) + Low Touch (Stage 2) | Experimental | Participants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth or in-person (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages alone (Stage 2) Receives: Behavioral: Active Choice; Behavioral: Low Touch Strategy |
| Active Choice (Stage 1) + High Touch (Stage 2) | Experimental | Participants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth or in-person (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages in combination with synchronous digital care coordination (Stage 2). Receives: Behavioral: Active Choice; Behavioral: High Touch Strategy |
| Telehealth Only (Stage 1) + Low Touch (Stage 2) | Experimental | Participants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth only (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages alone (Stage 2). Receives: Behavioral: Telehealth Only; Behavioral: Low Touch Strategy |
| Telehealth Only (Stage 1) + High Touch (Stage 2) | Experimental | Participants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth only (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages in combination with synchronous digital care coordination (Stage 2). Receives: Behavioral: Telehealth Only; Behavioral: High Touch Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shared decision making (SDM) for lung cancer screening (LCS)
Completion of an SDM visit (in person or telehealth) defined as any completed encounter that has documented SDM for LCS as indicated by 1) procedure code (G0296 or equivalent), or documentation of SDM conversation related to LCS in associated progress notes.
Measured: 90 days after randomization
Secondary outcomes (1)
Low-dose computed tomography (LDCT)
Completion of LDCT within 6 months of randomization date among individuals who complete SDM and are determined to be eligible for LCS.
Measured: 6 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 posted15 Oct 2024
- Study start9 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Detection of CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This study uses a sequential randomization design in which all eligible participants will be randomized into one of two interventions at Stage 1 and then participants that do not respond to Stage 1 interventions will be randomized to receive Stage 2 interventions
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Katharine Rendle, Abramson Cancer Center at Penn Medicine
- Investigators
- Katharine Rendle, PhD, Principal investigator, Abramson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638554
- Sponsor's protocol ID
- UPCC 04524
- Other IDs
- P50CA271338, 850376
- Acronym
- ITALCS
- Status last verified
- May 2026
- First submitted
- 9 Oct 2024
- Last updated
- 29 May 2026
- Results posted
- 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 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Telehealth to Advance Lung Cancer Screening
- ClinicalTrials.gov ID
- NCT06638554
- Acronym / sponsor ID
- ITALCS / UPCC 04524
- Conditions
- Early Detection of Cancer, Telemedicine, Decision Making
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Oct 2024 (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 goal of this pragmatic trial is to learn if telehealth strategies can increase shared decision-making (SDM) for lung cancer screening (LCS). It will also learn about the equity of these strategies by conducting non-inferiority analysis by race and sex. The main questions it aims to answer are:
- Does patient outreach using synchronous and asynchronous telehealth strategies increase completion of SDM visits for LCS?
- Is the effectiveness of these telehealth strategies similar by race and sex?
The study uses a Sequential Multiple Assignment Randomized Trial (SMART) design and includes two stages of interventions. The first stage of intervention includes direct patient outreach with an invitation to schedule either a 1) telehealth SDM visit or 2) telehealth or in-person SDM visit. Participants that do not respond to the first stage interventions receive a text message reminder encouraging SDM visit completion with or without digital care coordination.
Detailed description
Annual lung cancer screening using low-dose computed tomography (LDCT) is associated with decreased lung cancer mortality but also with harms. As such, it is recommended, and required for reimbursement, that patients complete an shared decision-making visit (SDM) prior to screening to discuss potential risks and benefits in the context of patient values. Despite guidelines recommending screening and national insurance coverage of LDCT, uptake of SDM visits and subsequent LDCT is remarkably low. We aim to address these gaps by comparing the effectiveness of synchronous and asynchronous telehealth strategies on SDM visits and subsequent LDCT in a pragmatic trial using a Sequential Multiple Assignment Randomized Trial (SMART) design. The specific first stage strategies to be tested are: a) Active Choice Outreach (invitation to schedule a telehealth or in-person SDM visit) vs b) Telehealth Only Outreach (invitation to schedule a telehealth SDM visit). The specific second stage strategies (delivered only if participants do not respond to first stage interventions) are a) text message reminders encouraging SDM visit completion (low-touch) alone or b) in combination with phone-based digital care coordination (high-touch). We will also assess non-inferiority of strategies by race and sex to assess equity of effectiveness.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- This study uses a sequential randomization design in which all eligible participants will be randomized into one of two interventions at Stage 1 and then participants that do not respond to Stage 1 interventions will be randomized to receive Stage 2 interventions
| Arm | Type | Receives |
|---|---|---|
| Active Choice (Stage 1) + Low Touch (Stage 2) | Experimental | Behavioral: Active Choice, Behavioral: Low Touch StrategyParticipants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth or in-person (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages alone (Stage 2) |
| Active Choice (Stage 1) + High Touch (Stage 2) | Experimental | Behavioral: Active Choice, Behavioral: High Touch StrategyParticipants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth or in-person (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages in combination with synchronous digital care coordination (Stage 2). |
| Telehealth Only (Stage 1) + Low Touch (Stage 2) | Experimental | Behavioral: Telehealth Only, Behavioral: Low Touch StrategyParticipants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth only (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages alone (Stage 2). |
| Telehealth Only (Stage 1) + High Touch (Stage 2) | Experimental | Behavioral: Telehealth Only, Behavioral: High Touch StrategyParticipants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth only (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages in combination with synchronous digital care coordination (Stage 2). |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- are aged 50 to 80
- have a history of tobacco use indicated by either: Documented 20 pack-year or greater smoking history in their electronic health record (EHR); OR Self-report via structured survey
- currently smoke or formerly smoked cigarettes
- have no documented history of lung cancer
- have no documented history of lung cancer screening in the 24 months prior to study enrollment
Key exclusion criteria (1 listed)
- Participants who do not meet inclusion criteria will not be eligible.
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 |
|---|---|---|
| Active ChoiceThe participant will be send a letter inviting them to complete a SDM visit either in-person or via telehealth. | Behavioural | Active Choice (Stage 1) + High Touch (Stage 2), Active Choice (Stage 1) + Low Touch (Stage 2) |
| Telehealth OnlyThe participant will be send a letter inviting them to complete a SDM visit via telehealth only. | Behavioural | Telehealth Only (Stage 1) + High Touch (Stage 2), Telehealth Only (Stage 1) + Low Touch (Stage 2) |
| Low Touch StrategyPatient will be sent asynchronous text messaging reminders encouraging SDM for LCS using framed messaging. | Behavioural | Active Choice (Stage 1) + Low Touch (Stage 2), Telehealth Only (Stage 1) + Low Touch (Stage 2) |
| High Touch StrategyPatient will be sent asynchronous text messaging reminders encouraging SDM for LCS using framed messaging in combination with synchronous telephone-based digital care coordination. | Behavioural | Active Choice (Stage 1) + High Touch (Stage 2), Telehealth Only (Stage 1) + High Touch (Stage 2) |
Primary outcome
Shared decision making (SDM) for lung cancer screening (LCS)
Time frame: 90 days after randomization
Completion of an SDM visit (in person or telehealth) defined as any completed encounter that has documented SDM for LCS as indicated by 1) procedure code (G0296 or equivalent), or documentation of SDM conversation related to LCS in associated progress notes.
1 secondary outcome
Low-dose computed tomography (LDCT)
Time frame: 6 months after randomization
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 29 May 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.
Katharine Rendle, PhD principal investigator
Abramson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Choice, Telehealth Only and Low Touch Strategy in people with Early Detection of Cancer and Telemedicine, 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 7 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: looking for participants now, as of the sponsor's last update on 29 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 Katharine Rendle, PhD (215-349-5442, katharine.rendle@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shared decision making (SDM) for lung cancer screening (LCS) (time frame: 90 days 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 29 May 2026.