TELESCOPE- TELEhealth Shared Decision-making COaching

Sponsor

Rutgers, The State University of New Jersey (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05491213

Collaborator

National Institutes of Health (NIH) (NIH)

420

Enrollment

Location

Arms

60.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Lung Neoplasms	Behavioral: TELESCOPE, Remote Decision Coaching with Navigation Intervention	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

420 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Quantitative measures of the PRISM constructs will be collected via internet surveys from the access and nurse navigators, clinic directors, and PCPs (n = 127 surveys), and through medical record review. Participants followed at TELESCOPE practices will also complete a measure of intervention acceptability at the one week survey for aim two semi-structured interviews will be conducted for aim two with a mix of 20 clinical, nursing, and administrative directors at the participating sites. All study navigators, seven, and 20 PCPs from TELESCOPE sites will also be interviewed.Quantitative measures of the PRISM constructs will be collected via internet surveys from the access and nurse navigators, clinic directors, and PCPs (n = 127 surveys), and through medical record review. Participants followed at TELESCOPE practices will also complete a measure of intervention acceptability at the one week survey for aim two semi-structured interviews will be conducted for aim two with a mix of 20 clinical, nursing, and administrative directors at the participating sites. All study navigators, seven, and 20 PCPs from TELESCOPE sites will also be interviewed.

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Anticipated Study Start Date :

Sep 30, 2022

Anticipated Primary Completion Date :

Jun 10, 2027

Anticipated Study Completion Date :

Oct 10, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TELESCOPE intervention 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 the the LDCT is ordered, support for screening, diagnostic testing and oncology care as needed from Nurse Navigator.	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
No Intervention: Enhanced usual care (EUC) Participants will be surveyed one week after the scheduled office visit (EUC patients) ) to collect primary and secondary outcome data related to the coaching and office visit.

Arm

Intervention/Treatment

Experimental: TELESCOPE intervention

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 the the LDCT is ordered, support for screening, diagnostic testing and oncology care as needed from Nurse Navigator.

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

No Intervention: Enhanced usual care (EUC)

Participants will be surveyed one week after the scheduled office visit (EUC patients) ) to collect primary and secondary outcome data related to the coaching and office visit.

Outcome Measures

Primary Outcome Measures

To assess hared decision making [The change in baseline, three months and five years]
Semi-structured interviews (qualitative data)

Secondary Outcome Measures

Tobacco treatment referral [The change in baseline, three months and five years]
Semi-structured interviews (qualitative data)

Other Outcome Measures

Receipt of tobacco treatment [The change in baseline, three months and five years]
Semi-structured interviews (qualitative data).
Completion of diagnostic testing [The change in baseline, three months and five years]
Semi-structured interviews (qualitative data).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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=47)

Participants completing the semi-structured interviews will be:

A practicing primary care provider or a clinic director, nursing director, or clinic administrative director (n=40) at one of the participating sites or a TELESCOPE study access navigator (n=5) and nurse navigator (n = 2)
Age 18 or older
Fluent in English Online surveys (N=127)

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=47)

Providers/administrators will be excluded if they:

Are unable to provide informed consent Online surveys (N=127)
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rutgers, Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08901

Sponsors and Collaborators

Rutgers, The State University of New Jersey
National Institutes of Health (NIH)

Investigators

Principal Investigator: Anita Y Kinney, PhD, Rutgers Cancer Institute of New Jersey

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anita Y. Kinney, PhD, RN, Director, Cancer Health Equity Center of Excellence, Rutgers, The State University of New Jersey

ClinicalTrials.gov Identifier:

NCT05491213

Other Study ID Numbers:

CINJ132207
Pro2022000340

First Posted:

Aug 8, 2022

Last Update Posted:

Aug 8, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Anita Y. Kinney, PhD, RN, Director, Cancer Health Equity Center of Excellence, Rutgers, The State University of New Jersey

Lung cancer screening

Additional relevant MeSH terms:

Lung Neoplasms

Study Results

No Results Posted as of Aug 8, 2022