TELESCOPE- TELEhealth Shared Decision-making COaching

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT05491213
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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

Study Details

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).

Key Dates

Start date
Feb 14, 2023
Status verified
Dec 2025
Primary completion
May 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
594 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: TELESCOPE intervention
    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.
  • No Intervention: Enhanced usual care (EUC)
    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.

Primary Outcome Measure

To assess shared decision making [ Time Frame: The change in baseline, three months and five years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Rutgers Cancer InstituteNew BrunswickNew Jersey08901
Julie E Chapman-Greene, PhD, MPH
732-865-3375
Rebecca Ayala
732-258-6982
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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