Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
594 participants
INTERVENTIONAL
2023-02-14
2027-01-31
Brief Summary
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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).
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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TELESCOPE intervention
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.
TELESCOPE, Remote Decision Coaching with Navigation Intervention
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
Enhanced usual care (EUC)
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.
No interventions assigned to this group
Interventions
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TELESCOPE, Remote Decision Coaching with Navigation Intervention
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
Eligibility Criteria
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Inclusion Criteria
* 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)
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
Exclusion Criteria
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
* 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.
18 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Rutgers, The State University of New Jersey
OTHER
Responsible Party
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Anita Y. Kinney, PhD, RN
Director at Rutgers Cancer Institute
Principal Investigators
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Anita Y Kinney, PhD, RN
Role: PRINCIPAL_INVESTIGATOR
Rutgers Cancer Institute
Locations
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Rutgers Cancer Institute
New Brunswick, New Jersey, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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. Res Sq [Preprint]. 2024 Apr 22:rs.3.rs-4254047. doi: 10.21203/rs.3.rs-4254047/v1.
Other Identifiers
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Pro2022000340
Identifier Type: OTHER
Identifier Source: secondary_id
132207
Identifier Type: -
Identifier Source: org_study_id
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