To hear about similar clinical trials, please enter your email below

Trial Title: TELESCOPE- TELEhealth Shared Decision-making COaching

NCT ID: NCT05491213

Condition: Lung Neoplasms

Conditions: Official terms:
Lung Neoplasms

Conditions: Keywords:
Lung cancer screening
Shared decision making

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention 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.

Primary purpose: Screening

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: TELESCOPE, Remote Decision Coaching with Navigation Intervention
Description: 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
Arm group label: TELESCOPE intervention

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).

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Gender based: Yes

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Rutgers, Cancer Institute of New Jersey

Address:
City: New Brunswick
Zip: 08901
Country: United States

Status: Recruiting

Contact:
Last name: Julie E Chapman-Greene, PhD, MPH

Phone: 732-865-3375
Email: chapmaje@cinj.rutgers.edu

Contact backup:
Last name: Rebecca Ayala

Phone: 732-258-6982
Email: raa191@cinj.rutgers.edu

Facility:
Name: The University of Texas MD Anderson Cancer Center

Address:
City: Houston
Zip: 77030
Country: United States

Status: Active, not recruiting

Start date: February 14, 2023

Completion date: December 31, 2027

Lead sponsor:
Agency: Rutgers, The State University of New Jersey
Agency class: Other

Collaborator:
Agency: National Institutes of Health (NIH)
Agency class: NIH

Collaborator:
Agency: National Heart, Lung, and Blood Institute (NHLBI)
Agency class: NIH

Source: Rutgers, The State University of New Jersey

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05491213

Login to your account

Did you forget your password?