Lung NeoplasmsNCT05491213
TELESCOPE- TELEhealth Shared Decision-making COaching
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 2 sites in United States.
Trial summary
Hypothesis 1a: The investigators anticipate that navigator decision coaching, compared to enhanced usual care (EUC) will result in higher quality SDM for lung cancer screening (LCS )(primary outcome), greater knowledge of lung cancer screening benefits and harms, and lower decisional conflict. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy 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
- 594 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Feb 2023to 16 Sep 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion Criteria Cluster Randomized Trial
- Eligibility of patients for the cluster randomized trial will follow United States Preventive Services Task Force criteria for lung cancer screening. Specifically, patients must:
- 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. Interviews (N=50)
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- Participants completing the semi-structured interviews will be:
- A practicing primary care clinician or a clinic director (n=20), nursing director, or clinic practice administrator (n=20) at one of the participating sites or a TELESCOPE study patient navigator (n=7) and nurse navigator (n = 3)
- Age 18 or older
- Fluent in English Online surveys (N=130)
- 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
- Cluster Randomized Trial
- Excluded will be patients who:
- Do not speak English
- Have a history lung cancer
- Were screened for lung cancer within the past 12 months
- Have health conditions that make them poor candidates for curative treatment as determined by the primary care provider
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- Are unable to provide informed consent Interviews (N=50)
- Providers/administrators will be excluded if they:
- Are unable to provide informed consent Online surveys (N=130)
- Are unable to provide informed consent
- Women who are pregnant. English proficiency is required for the completion of surveys, and the intervention will be conducted in English.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901
About this study
Official title: TELEhealth Shared Decision-making COaching for Lung Cancer Screening in Primary carE (TELESCOPE)
Hypothesis 1a: The investigators anticipate that navigator decision coaching, compared to enhanced usual care (EUC) will result in higher quality SDM for lung cancer screening (LCS )(primary outcome), greater knowledge of lung cancer screening benefits and harms, and lower decisional conflict.
Hypothesis 1b: Compared to enhanced usual care (EUC), we expect that TELESCOPE will result in more screening discussions, increased initial for lung cancer screening (LCS) with low-dose CT scan (LDCT) uptake among interested participants, increased adherence to repeat LCS and diagnostic testing, and increased smoking cessation referrals for current smokers.
Hypothesis 2: The investigators expect that a "booster" coaching session will increase adherence to repeat lung cancer screening (LCS).
Read the detailed description
The investigators' primary objective is to compare the effectiveness of the TELESCOPE intervention vs. enhanced usual care (EUC) on shared decision-making (SDM) for lung cancer screening.
Secondary objectives are to test the effectiveness of the TELESCOPE intervention vs. EUC on screening uptake, adherence with diagnostic testing and annual testing, and smoking cessation referrals and receipt of tobacco treatment for current smokers. The investigators will also use a mixed methods approach to evaluate the implementation potential of navigator-led decision coaching for lung cancer screening (LCS ) and identify components and organizational and individual level characteristics that might facilitate or interfere with successful implementation.
- Conditions
- Lung Neoplasms
- Being tested
- TELESCOPE, Remote Decision Coaching with Navigation Intervention
- Keywords
- Lung cancer screening, Shared decision making
- Medical subject headings
- Lung Neoplasms
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 (EUC) | 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.
To assess shared decision making
Semi-structured interviews (qualitative data)
Measured: The change in baseline, three months and five years
Secondary outcomes (2)
Tobacco treatment referral
Semi-structured interviews (qualitative data)
Measured: The change in baseline, three months and five years
Uptake of Low-Dose CT Screening for Lung Cancer
Proportion of participants who complete low-dose CT (LDCT) lung cancer screening within 6 months post-intervention.
Measured: Within 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start14 Feb 2023
- Primary completion2 Apr 2026
- Study completion16 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Quantitative measures of the PRISM constructs will be collected via internet surveys from the patient and nurse navigators, clinic directors, and clinicians (n = 130 surveys), and through medical record review. Participants followed at the TELESCOPE arm sites will also complete a measure of intervention acceptability at the one week survey for Aim 2. Semi-structured interviews will be conducted for Aim 2 with a mix of 20 clinical, nursing, and administrative directors at the participating sites. All 10 study navigators, and 20 clinicians from the TELESCOPE arm sites will also be interviewed.
- Masking
- None (open label)
- Enrolment
- 594 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Anita Y. Kinney, PhD, RN, Rutgers, The State University of New Jersey
- Investigators
- Anita Y Kinney, PhD, RN, Principal investigator, Rutgers Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491213
- Sponsor's protocol ID
- 132207
- Other IDs
- Pro2022000340, 1R01HL158850-01A1
- Status last verified
- Oct 2026
- First submitted
- 4 Aug 2022
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tan NQP, Lowenstein LM, Douglas EE, Silva J, Bershad JM, An J, Shete SS, Steinberg MB, Ferrante JM, Clark EC, Natale-Pereira A, Sahu NN, Hastings SE, Hoffman RM, Volk RJ, Kinney AY. The TELEhealth Shared decision-making COaching and navigation in Primary carE (TELESCOPE) intervention: a study protocol for delivering shared decision-making for lung cancer screening by patient navigators. BMC Prim Care. 2024 Oct 18;25(1):373. doi: 10.1186/s12875-024-02610-2.
PubMed 39425032Tan NQP, Lowenstein LM, Douglas EE, Silva J, Bershad JM, An J, Shete SS, Steinberg MB, Ferrante JM, Clark EC, Natale-Pereira A, Sahu NN, Hastings SE, Hoffman RM, Volk RJ, Kinney AY. The TELEhealth Shared decision-making Coaching and Navigation in Primary carE (TELESCOPE) intervention: a study protocol for delivering shared decision-making for lung cancer screening by patient navigators. Res Sq [Preprint]. 2024 Apr 22:rs.3.rs-4254047. doi: 10.21203/rs.3.rs-4254047/v1.
PubMed 38746205
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. 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)
- ClinicalTrials.gov ID
- NCT05491213
- Acronym / sponsor ID
- 132207
- Conditions
- Lung Neoplasms
- Keywords
- Lung cancer screening, Shared decision making
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 594 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 2 Apr 2026 (actual)
- Study completion
- 16 Sep 2027 (estimated)
- First posted
- 8 Aug 2022 (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.
Hypothesis 1a: The investigators anticipate that navigator decision coaching, compared to enhanced usual care (EUC) will result in higher quality SDM for lung cancer screening (LCS )(primary outcome), greater knowledge of lung cancer screening benefits and harms, and lower decisional conflict.
Hypothesis 1b: Compared to enhanced usual care (EUC), we expect that TELESCOPE will result in more screening discussions, increased initial for lung cancer screening (LCS) with low-dose CT scan (LDCT) uptake among interested participants, increased adherence to repeat LCS and diagnostic testing, and increased smoking cessation referrals for current smokers.
Hypothesis 2: The investigators expect that a "booster" coaching session will increase adherence to repeat lung cancer screening (LCS).
Detailed description
The investigators' primary objective is to compare the effectiveness of the TELESCOPE intervention vs. enhanced usual care (EUC) on shared decision-making (SDM) for lung cancer screening.
Secondary objectives are to test the effectiveness of the TELESCOPE intervention vs. EUC on screening uptake, adherence with diagnostic testing and annual testing, and smoking cessation referrals and receipt of tobacco treatment for current smokers. The investigators will also use a mixed methods approach to evaluate the implementation potential of navigator-led decision coaching for lung cancer screening (LCS ) and identify components and organizational and individual level characteristics that might facilitate or interfere with successful implementation.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Quantitative measures of the PRISM constructs will be collected via internet surveys from the patient and nurse navigators, clinic directors, and clinicians (n = 130 surveys), and through medical record review. Participants followed at the TELESCOPE arm sites will also complete a measure of intervention acceptability at the one week survey for Aim 2. Semi-structured interviews will be conducted for Aim 2 with a mix of 20 clinical, nursing, and administrative directors at the participating sites. All 10 study navigators, and 20 clinicians from the TELESCOPE arm sites will also be interviewed.
| 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 (EUC) | 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
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Inclusion Criteria Cluster Randomized Trial
- Eligibility of patients for the cluster randomized trial will follow United States Preventive Services Task Force criteria for lung cancer screening. Specifically, patients must:
- 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
Key exclusion criteria (11 listed)
- Cluster Randomized Trial
- Do not speak English
- Have a history lung cancer
- Were screened for lung cancer within the past 12 months
- Have health conditions that make them poor candidates for curative treatment as determined by the primary care provider
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
To assess shared decision making
Time frame: The change in baseline, three months and five years
Semi-structured interviews (qualitative data)
2 secondary outcomes
Tobacco treatment referral
Time frame: The change in baseline, three months and five years
Uptake of Low-Dose CT Screening for Lung Cancer
Time frame: Within 6 months 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 14 Oct 2026.
- Derived from this study: PubMed 39425032Tan NQP, Lowenstein LM, Douglas EE, Silva J, Bershad JM, An J, Shete SS, Steinberg MB, Ferrante JM, Clark EC, Natale-Pereira A, Sahu NN, Hastings SE, Hoffman RM, Volk RJ, Kinney AY. The TELEhealth Shared decision-making COaching and navigation in Primary carE (TELESCOPE) intervention: a study protocol for delivering shared decision-making for lung cancer screening by patient navigators. BMC Prim Care. 2024 Oct 18;25(1):373. doi: 10.1186/s12875-024-02610-2.
- Derived from this study: PubMed 38746205Tan NQP, Lowenstein LM, Douglas EE, Silva J, Bershad JM, An J, Shete SS, Steinberg MB, Ferrante JM, Clark EC, Natale-Pereira A, Sahu NN, Hastings SE, Hoffman RM, Volk RJ, Kinney AY. The TELEhealth Shared decision-making Coaching and Navigation in Primary carE (TELESCOPE) intervention: a study protocol for delivering shared decision-making for lung cancer screening by patient navigators. Res Sq [Preprint]. 2024 Apr 22:rs.3.rs-4254047. doi: 10.21203/rs.3.rs-4254047/v1.
- 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.
Anita Y Kinney, PhD, RN principal investigator
Rutgers Cancer Institute
2 sites 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 2 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 14 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 14 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 2 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?
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?
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?
To assess shared decision making (time frame: The change in baseline, three months and five years). 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 NCT05491213, which also lists 2 linked publications.
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 14 Oct 2026.