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TELESCOPE- TELEhealth Shared Decision-making COaching

Primary Purpose

Lung Neoplasms

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

TELESCOPE, Remote Decision Coaching with Navigation Intervention

About this trial

This is an interventional screening trial for Lung Neoplasms focused on measuring Lung cancer screening, Shared decision making

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Rutgers, Cancer Institute of New JerseyRecruiting
The University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TELESCOPE intervention

Enhanced usual care (EUC)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

To assess shared decision making

Semi-structured interviews (qualitative data)

Secondary Outcome Measures

Tobacco treatment referral

Semi-structured interviews (qualitative data)

Full Information

NCT ID

NCT05491213

First Posted

August 4, 2022

Last Updated

July 20, 2023

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT05491213

Brief Title

TELESCOPE- TELEhealth Shared Decision-making COaching

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 14, 2023 (Actual)

Primary Completion Date

December 31, 2026 (Anticipated)

Study Completion Date

December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Neoplasms

Keywords

Lung cancer screening, Shared decision making

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TELESCOPE intervention

Arm Type

Experimental

Arm Description

Arm Title

Enhanced usual care (EUC)

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

TELESCOPE, Remote Decision Coaching with Navigation Intervention

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

Primary Outcome Measure Information:

Title

To assess shared decision making

Description

Semi-structured interviews (qualitative data)

Time Frame

The change in baseline, three months and five years

Secondary Outcome Measure Information:

Title

Tobacco treatment referral

Description

Semi-structured interviews (qualitative data)

Time Frame

The change in baseline, three months and five years

Other Pre-specified Outcome Measures:

Title

Receipt of tobacco treatment

Description

Semi-structured interviews (qualitative data).

Time Frame

The change in baseline, three months and five years

Title

Completion of diagnostic testing

Description

Semi-structured interviews (qualitative data).

Time Frame

The change in baseline, three months and five years

10. Eligibility

Sex

All

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sarah Foran

Phone

732-258-6045

sef123@cinj.rutgers.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anita Y Kinney, PhD, RN

Organizational Affiliation

Rutgers Cancer Institute of New Jersey

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rutgers, Cancer Institute of New Jersey

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08901

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sarah Foran

Phone

732-235-8871

sarah.foran@rutgers.edu

Facility Name

The University of Texas MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD

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