Clinical trial NCT05491213: TELESCOPE- TELEhealth Shared Decision-making COaching
Official title: TELEhealth Shared Decision-making COaching for Lung Cancer Screening in Primary CarE (TELESCOPE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Neoplasms
Keywords: Lung cancer screening
Shared decision making
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-08-08
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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).

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.

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.

Primary outcomes:
measure: To assess shared decision making
timeFrame: The change in baseline, three months and five years
Secondary outcomes:
measure: Tobacco treatment referral
timeFrame: The change in baseline, three months and five years
Other outcomes:
measure: Receipt of tobacco treatment
timeFrame: The change in baseline, three months and five years
measure: Completion of diagnostic testing
timeFrame: The change in baseline, three months and five years
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute
state: New Jersey
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Rutgers Cancer Institute
name: Anita Y Kinney, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: