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