Lung NeoplasmsTELESCOPE-HNCT07165691
TELEhealth Shared Decision-making COaching for Lung Cancer Screening in Primary Care (TELESCOPE) for Hispanics
A study testing TELESCOPE, Remote Decision Coaching with Navigation Intervention in people with Lung Neoplasms, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
Aim 1: Culturally adapt the TELESCOPE intervention for Hispanics. Using iterative qualitative feedback from a study-specific Community Advisory Board, focus groups, and interviews with community members, the investigators will culturally adapt the TELESCOPE intervention for Hispanics at high risk for lung cancer. Read more about this study
- Who is it for?
- Ages 50 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- TELESCOPE, Remote Decision Coaching with Navigation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2025to 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 77 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aim 1 (Cultural Adaptation):
- To be eligible, patients must:
- Identify as Hispanic and/or Latino(a)
- Able to read and speak in English or Spanish
- Be 50 to 77 years of age
- Be a current or former smoker
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- Have at least a 20-pack-year smoking history
- Aims 2-3 (Pilot Randomized Controlled Trial)
- To be eligible, patients must:
- Identify as Hispanic or Latino(a)
- Able to speak and read in English or Spanish
- Be 50 to 77 years of age
- Be a current or former smoker having quit within the past 15 years
- Have at least a 20 pack-year smoking history
- Be scheduled for a non-acute care visit at one of the study sites.
- Not coughing up blood in the last two weeks
- Interviews
- Providers completing the semi-structured interviews will be:
- A practicing primary care clinician or a clinic director (n=20), nursing director, or clinic practice administrator at one of the participating sites, or a TELESCOPE study patient navigator and nurse navigator
- Age 18 or older
- Fluent in English
- Online surveys
- Providers completing online PRISM construct surveys will be:
- A practicing primary care provider at one of the participating sites or a TELESCOPE study navigator
- Age 18 or older
- Fluent in English
Who cannot join
- For the cluster randomized trial, excluded will be patients who:
- Do not speak English
- Are not Hispanic or Latino(a)
- Have a history of lung cancer
- Had a CT scan in the past 12 months
- Has been coughing up blood in the last two weeks
Show all 12Show fewer
- Have health conditions that make them poor candidates for curative treatment as determined by the primary care provider,
- Are unable to provide informed consent Interviews
- Providers/administrators will be excluded if they:
- Are unable to provide informed consent Online surveys
- Are unable to provide informed consent
- Women who are pregnant.
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
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901
Evelyn Arana, DrPH, 908-642-0861, earana@cinj.rutgers.edu
Evelyn Arana, DrPH
About this study
Aim 1: Culturally adapt the TELESCOPE intervention for Hispanics. Using iterative qualitative feedback from a study-specific Community Advisory Board, focus groups, and interviews with community members, the investigators will culturally adapt the TELESCOPE intervention for Hispanics at high risk for lung cancer.
Aim 2: Assess the feasibility, acceptability, and implementation potential of the culturally adapted TELESCOPE intervention delivered by bilingual patient navigators for Hispanics. Hypothesis 1: The investigators expect a recruitment rate of ≥60%, ≥90% of Hispanic participants will complete the 1-week follow-up assessments, ≥80% of the key intervention components will be delivered with 80% fidelity by the patient navigators, and ≥90% of participants and clinicians will agree or completely agree that the intervention was feasible and acceptable.
Aim 3: Explore the impact of a culturally adapted TELESCOPE intervention delivered by bilingual patient navigators vs enhanced usual care (EUC) on the initial uptake of low-dose computed tomography (LDCT) and quality of the shared decision-making (SDM) process. Hypothesis 2: The investigators expect that an adapted TELESCOPE intervention will result in higher uptake of LDCT and higher SDM quality for lung cancer screening (LCS) compared to EUC.
Read the detailed description
This pilot feasibility trial aims to culturally adapt an existing TELESCOPE (R01HL158850) intervention to create a culturally appropriate SDM and navigation intervention for Hispanics in primary care settings. The investigators will assess its feasibility and acceptability (primary outcomes), and explore its impact on the uptake of LDCT (secondary outcome) compared to enhanced usual care (training clinicians to discuss LCS) for LCS in Hispanics.
- Conditions
- Lung Neoplasms
- Being tested
- TELESCOPE, Remote Decision Coaching with Navigation Intervention
- Keywords
- lung cancer screening, shared decision making, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Diseases, Lung Neoplasms
- Medical subject headings
- Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TELESCOPE, Remote Decision Coaching with Navigation InterventionBehavioural
The TELESCOPE intervention involves three complementary components: 1) decision aid and coaching for LCS, 2) referral of current smokers to evidence-based smoking cessation services, and 3) for participants interested in screening, navigation to complete LCS and diagnostic testing and oncology care as needed
| Study group | Role | What they receive |
|---|---|---|
| TELESCOPE intervention | Experimental | Participants will be surveyed at baseline and at one-week after the scheduled primary care office visit. If a participant is a current smoker then they are offered and navigated to evidence-based smoking cessation. If the participant is interested in screening, an LDCT is ordered. Support for screening, diagnostic testing and oncology care will be provided as needed from the Nurse Navigators. Receives: Behavioral: TELESCOPE, Remote Decision Coaching with Navigation Intervention |
| Enhanced Usual Care | No intervention | Participants will be surveyed at baseline and at one-week after the scheduled primary care office visit. Primary and secondary outcome data related to the office visit will be collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
The investigators expect a recruitment rate of ≥60%.
Measured: 1 week post-intervention
Participant Acceptability
The Ottawa Acceptability Measure will assess the acceptability of the TELESCOPE intervention from the patient's perspective at 1-week post-intervention. There is no total score for this measure. Responses will be reported descriptively in terms of proportions responding positively or negatively for each criteria.
Measured: 1 week post-intervention
Follow-up completion rate
The investigators expect that ≥90% of Hispanic participants will complete the 1-week follow-up assessments
Measured: 1 week post-intervention
Intervention Fidelity Rate
The investigators expect that ≥80% of the key intervention components will be delivered with 80% fidelity by the patient navigators.
Measured: 1 week post-intervention
Secondary outcomes (5)
Rate of participants that have completed LDCT
The investigators will assess the rates of completion of LDCT at 3 months post-intervention for all participants. This will be abstracted from patients' medical records.
Measured: 3 months post-intervention
To assess shared decision making quality
This will be assessed with the Shared Decision-Making Process Survey (SDM Process_4), which is a 4-item performance measure of the process and outcome of shared decision making. Scores range from 0 to 4, with higher scores indicating a better process.
Measured: 1 week post-intervention
Feasibility of intervention (Clinicians)
The feasibility of the intervention (FIM) measure will be completed by clinicians. The total score for this instrument ranges from 4 to 20, with higher scores indicating greater feasibility.
Measured: 12 months post-intervention
Clinicians Acceptability
The acceptability of the intervention (AIM) will be completed by clinicians. The total score ranges from 4 to 20, with higher scores indicating greater acceptability.
Measured: 12 months post-intervention
Intervention Appropriateness (Clinicians)
The Intervention Appropriateness Measure (IAM) will be completed by clinicians. The total score for each instrument ranges from 4 to 20, with higher scores indicating greater acceptability.
Measured: Post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start11 Sep 2025
- Primary completion30 Jun 2027 (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 Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Model description
- The investigators will conduct three focus groups and interviews to culturally adapt the intervention materials for a heterogeneous Hispanic population (Aim 1). After the intervention is culturally adapted, clinicians serving large numbers of Hispanic patients will be the unit of randomization (Aims 2-3). The investigators will randomize 1:1 clinicians to the culturally adapted intervention (TELESCOPE) versus enhanced usual care (EUC). Patients of clinicians will all be assigned to the arm to which the clinician was assigned.
- Masking
- None (open label)
- Enrolment
- 91 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- New Jersey Commission on Cancer Research
- Responsible party
- Principal investigator, Evelyn Arana, DrPH, Rutgers, The State University of New Jersey
- Investigators
- Evelyn Arana, DrPH, Principal investigator, Rutgers Cancer Institute of NJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165691
- Sponsor's protocol ID
- Pro2025001472
- Acronym
- TELESCOPE-H
- Status last verified
- Nov 2025
- First submitted
- 26 Aug 2025
- Last updated
- 2 Dec 2025
- 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 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TELEhealth Shared Decision-making COaching for Lung Cancer Screening in Primary Care (TELESCOPE) for Hispanics
- ClinicalTrials.gov ID
- NCT07165691
- Acronym / sponsor ID
- TELESCOPE-H / Pro2025001472
- Conditions
- Lung Neoplasms
- Keywords
- lung cancer screening, shared decision making, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 91 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- New Jersey Commission on Cancer Research
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 10 Sep 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.
Aim 1: Culturally adapt the TELESCOPE intervention for Hispanics. Using iterative qualitative feedback from a study-specific Community Advisory Board, focus groups, and interviews with community members, the investigators will culturally adapt the TELESCOPE intervention for Hispanics at high risk for lung cancer.
Aim 2: Assess the feasibility, acceptability, and implementation potential of the culturally adapted TELESCOPE intervention delivered by bilingual patient navigators for Hispanics. Hypothesis 1: The investigators expect a recruitment rate of ≥60%, ≥90% of Hispanic participants will complete the 1-week follow-up assessments, ≥80% of the key intervention components will be delivered with 80% fidelity by the patient navigators, and ≥90% of participants and clinicians will agree or completely agree that the intervention was feasible and acceptable.
Aim 3: Explore the impact of a culturally adapted TELESCOPE intervention delivered by bilingual patient navigators vs enhanced usual care (EUC) on the initial uptake of low-dose computed tomography (LDCT) and quality of the shared decision-making (SDM) process. Hypothesis 2: The investigators expect that an adapted TELESCOPE intervention will result in higher uptake of LDCT and higher SDM quality for lung cancer screening (LCS) compared to EUC.
Detailed description
This pilot feasibility trial aims to culturally adapt an existing TELESCOPE (R01HL158850) intervention to create a culturally appropriate SDM and navigation intervention for Hispanics in primary care settings. The investigators will assess its feasibility and acceptability (primary outcomes), and explore its impact on the uptake of LDCT (secondary outcome) compared to enhanced usual care (training clinicians to discuss LCS) for LCS in Hispanics.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will conduct three focus groups and interviews to culturally adapt the intervention materials for a heterogeneous Hispanic population (Aim 1). After the intervention is culturally adapted, clinicians serving large numbers of Hispanic patients will be the unit of randomization (Aims 2-3). The investigators will randomize 1:1 clinicians to the culturally adapted intervention (TELESCOPE) versus enhanced usual care (EUC). Patients of clinicians will all be assigned to the arm to which the clinician was assigned.
| Arm | Type | Receives |
|---|---|---|
| TELESCOPE intervention | Experimental | Behavioral: TELESCOPE, Remote Decision Coaching with Navigation InterventionParticipants will be surveyed at baseline and at one-week after the scheduled primary care office visit. If a participant is a current smoker then they are offered and navigated to evidence-based smoking cessation. If the participant is interested in screening, an LDCT is ordered. Support for screening, diagnostic testing and oncology care will be provided as needed from the Nurse Navigators. |
| Enhanced Usual Care | No intervention | –Participants will be surveyed at baseline and at one-week after the scheduled primary care office visit. Primary and secondary outcome data related to the office visit will be collected. |
Who may qualify
- Ages
- 50 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Identify as Hispanic and/or Latino(a)
- Able to read and speak in English or Spanish
- Be 50 to 77 years of age
- Be a current or former smoker
- Have at least a 20-pack-year smoking history
Key exclusion criteria (12 listed)
- Do not speak English
- Are not Hispanic or Latino(a)
- Have a history of lung cancer
- Had a CT scan in the past 12 months
- Has been coughing up blood in the last two weeks
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 |
|---|---|---|
| TELESCOPE, Remote Decision Coaching with Navigation InterventionThe TELESCOPE intervention involves three complementary components: 1) decision aid and coaching for LCS, 2) referral of current smokers to evidence-based smoking cessation services, and 3) for participants interested in screening, navigation to complete LCS and diagnostic testing and oncology care as needed | Behavioural | TELESCOPE intervention |
Primary outcome
Recruitment rate
Time frame: 1 week post-intervention
The investigators expect a recruitment rate of ≥60%.
Participant Acceptability
Time frame: 1 week post-intervention
The Ottawa Acceptability Measure will assess the acceptability of the TELESCOPE intervention from the patient's perspective at 1-week post-intervention. There is no total score for this measure. Responses will be reported descriptively in terms of proportions responding positively or negatively for each criteria.
Follow-up completion rate
Time frame: 1 week post-intervention
The investigators expect that ≥90% of Hispanic participants will complete the 1-week follow-up assessments
Intervention Fidelity Rate
Time frame: 1 week post-intervention
The investigators expect that ≥80% of the key intervention components will be delivered with 80% fidelity by the patient navigators.
5 secondary outcomes
Rate of participants that have completed LDCT
Time frame: 3 months post-intervention
To assess shared decision making quality
Time frame: 1 week post-intervention
Feasibility of intervention (Clinicians)
Time frame: 12 months post-intervention
Clinicians Acceptability
Time frame: 12 months post-intervention
Intervention Appropriateness (Clinicians)
Time frame: Post-intervention
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 2 Dec 2025.
- 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.
Evelyn Arana, DrPH principal investigator
Rutgers Cancer Institute of NJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TELESCOPE, Remote Decision Coaching with Navigation Intervention in people with Lung Neoplasms, run by Rutgers, The State University of New Jersey 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 26 inclusion and 12 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 2 Dec 2025. 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 Evelyn Arana, DrPH (9086420861, earana@cinj.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 1 week post-intervention). The study lists 4 primary outcomes in all. 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 2 Dec 2025.