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| ID | Type | Description | Link |
|---|---|---|---|
| Pro2022000340 | Other Identifier | Rutgers | |
| 1R01HL158850-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TELESCOPE intervention | Experimental | 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. |
|
| Enhanced usual care (EUC) | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess shared decision making | Semi-structured interviews (qualitative data) | The change in baseline, three months and five years |
| Measure | Description | Time Frame |
|---|---|---|
| Tobacco treatment referral | Semi-structured interviews (qualitative data) | The change in baseline, three months and five years |
| Uptake of Low-Dose CT Screening for Lung Cancer | Proportion of participants who complete low-dose CT (LDCT) lung cancer screening within 6 months post-intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Receipt of tobacco treatment | Semi-structured interviews (qualitative data). | The change in baseline, three months and five years |
| Completion of diagnostic testing | Semi-structured interviews (qualitative data). |
Inclusion Criteria:
- Inclusion Criteria Cluster Randomized Trial
Eligibility of patients for the cluster randomized trial will follow United States Preventive Services Task Force criteria for lung cancer screening. Specifically, patients must:
Participants completing the semi-structured interviews will be:
Providers completing online PRISM construct surveys will be:
Exclusion Criteria:
- Cluster Randomized Trial
Excluded will be patients who:
Providers/administrators will be excluded if they:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie E Chapman-Greene, PhD, MPH | Contact | 732-865-3375 | chapmaje@cinj.rutgers.edu | |
| Rebecca Ayala | Contact | 732-258-6982 | raa191@cinj.rutgers.edu |
| Name | Affiliation | Role |
|---|---|---|
| Anita Y Kinney, PhD, RN | Rutgers Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers Cancer Institute | Recruiting | New Brunswick | New Jersey | 08901 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39425032 | Derived | Tan NQP, Lowenstein LM, Douglas EE, Silva J, Bershad JM, An J, Shete SS, Steinberg MB, Ferrante JM, Clark EC, Natale-Pereira A, Sahu NN, Hastings SE, Hoffman RM, Volk RJ, Kinney AY. The TELEhealth Shared decision-making COaching and navigation in Primary carE (TELESCOPE) intervention: a study protocol for delivering shared decision-making for lung cancer screening by patient navigators. BMC Prim Care. 2024 Oct 18;25(1):373. doi: 10.1186/s12875-024-02610-2. | |
| 38746205 |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D061351 | Telescopes |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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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.
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|
| Within 6 months post-intervention |
| The change in baseline, three months and five years |
| The University of Texas MD Anderson Cancer Center | Active, not recruiting | Houston | Texas | 77030 | United States |
| Tan NQP, Lowenstein LM, Douglas EE, Silva J, Bershad JM, An J, Shete SS, Steinberg MB, Ferrante JM, Clark EC, Natale-Pereira A, Sahu NN, Hastings SE, Hoffman RM, Volk RJ, Kinney AY. The TELEhealth Shared decision-making Coaching and Navigation in Primary carE (TELESCOPE) intervention: a study protocol for delivering shared decision-making for lung cancer screening by patient navigators. Res Sq [Preprint]. 2024 Apr 22:rs.3.rs-4254047. doi: 10.21203/rs.3.rs-4254047/v1. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |