TELESCOPE- TELEhealth Shared Decision-making COaching

NCT05491213 | Recruiting DMC

• 3 other identifiers: 132207Pro20220003401R01HL158850-01A1
• Study Type: interventional
• Target: 594
• Locations: 1 country
• Sites: 2

Brief 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. 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).

Conditions

Lung Neoplasms

Keywords

Lung cancer screening; Shared decision making

Outcome Measures

Primary Outcomes (1)

• To assess shared decision making

  Semi-structured interviews (qualitative data)

  The change in baseline, three months and five years

Secondary Outcomes (2)

• Tobacco treatment referral

  The change in baseline, three months and five years

• Uptake of Low-Dose CT Screening for Lung Cancer

  Within 6 months post-intervention

Other Outcomes (2)

• Receipt of tobacco treatment

  The change in baseline, three months and five years

• Completion of diagnostic testing

  The change in baseline, three months and five years

Study Arms (2)

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.

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.

Interventions

TELESCOPE, Remote Decision Coaching with Navigation Intervention BEHAVIORAL

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

TELESCOPE intervention

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Rutgers Cancer Institute

New Brunswick, New Jersey, 08901, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

ACTIVE NOT RECRUITING

Related Publications (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. BMC Prim Care. 2024 Oct 18;25(1):373. doi: 10.1186/s12875-024-02610-2.

  PMID: 39425032 DERIVED

• 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.

  PMID: 38746205 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Telescopes

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies

Study Officials

• Anita Y Kinney, PhD, RN

  Rutgers Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie E Chapman-Greene, PhD, MPH

CONTACT

732-865-3375; chapmaje@cinj.rutgers.edu

Rebecca Ayala

CONTACT

732-258-6982; raa191@cinj.rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director at Rutgers Cancer Institute

Model Details: 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.

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 8, 2022
• Study Start: February 14, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)