TELESCOPE- TELEhealth Shared Decision-making COaching

Lung Neoplasms Clinical Trial

Official title:

TELEhealth Shared Decision-making COaching for Lung Cancer Screening in Primary carE (TELESCOPE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05491213
• Other study ID #: 132207
• Secondary ID: Pro20220003401R0
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: January 2024
• Source: Rutgers, The State University of New Jersey
• Contact: Sarah Foran
• Phone: 732-258-6045
• Email: sef123[@]cinj.rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inclusion Criteria Cluster Randomized Trial (N=420) 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 (N=420)

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.

Related Conditions & MeSH terms

• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Rutgers, Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Receipt of tobacco treatment	Semi-structured interviews (qualitative data).	The change in baseline, three months and five years
Other	Completion of diagnostic testing	Semi-structured interviews (qualitative data).	The change in baseline, three months and five years
Primary	To assess shared decision making	Semi-structured interviews (qualitative data)	The change in baseline, three months and five years
Secondary	Tobacco treatment referral	Semi-structured interviews (qualitative data)	The change in baseline, three months and five years