TELESCOPE- TELEhealth Shared Decision-making COaching

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).

Study Overview

• Status: Recruiting
• Conditions: Lung Neoplasms
• Intervention / Treatment: Behavioral: TELESCOPE, Remote Decision Coaching with Navigation Intervention

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 Type: Interventional
• Enrollment (Estimated): 594
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julie E Chapman-Greene, PhD, MPH; Phone Number: 732-865-3375; Email: chapmaje@cinj.rutgers.edu
• Study Contact Backup: Name: Rebecca Ayala; Phone Number: 732-258-6982; Email: raa191@cinj.rutgers.edu

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • Rutgers Cancer Institute
      • Contact: Julie E Chapman-Greene, PhD, MPH; Phone Number: 732-865-3375; Email: chapmaje@cinj.rutgers.edu
      • Contact: Rebecca Ayala; Phone Number: 732-258-6982; Email: raa191@cinj.rutgers.edu
  • Texas
    • Houston, Texas, United States, 77030
      • Active, not recruiting
      • The University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

- 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)

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:

- 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
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess shared decision making	Semi-structured interviews (qualitative data)	The change in baseline, three months and five years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tobacco treatment referral	Semi-structured interviews (qualitative data)	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.	Within 6 months post-intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Receipt of tobacco treatment	Semi-structured interviews (qualitative data).	The change in baseline, three months and five years
Completion of diagnostic testing	Semi-structured interviews (qualitative data).	The change in baseline, three months and five years

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Anita Y Kinney, PhD, RN, Rutgers Cancer Institute

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: August 4, 2022
• First Submitted That Met QC Criteria: August 4, 2022
• First Posted (Actual): August 8, 2022

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Shared decision making; Lung cancer screening
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Equipment and Supplies; Optical Devices; Telescopes
• Other Study ID Numbers: 132207; Pro2022000340 (Other Identifier: Rutgers); 1R01HL158850-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No