TELESCOPE- TELEhealth Shared Decision-making COaching

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• To assess shared decision making [Срок оценки: The change in baseline, three months and five years]

Вторичные конечные точки (2)

• Tobacco treatment referral [Срок оценки: The change in baseline, three months and five years]
• Uptake of Low-Dose CT Screening for Lung Cancer [Срок оценки: Within 6 months post-intervention]

Критерии участия

Критерии включения

\- 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:

• 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

Критерии исключения

\- Cluster Randomized Trial

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

США · 2 центра

• Rutgers Cancer Institute — New Brunswick
• The University of Texas MD Anderson Cancer Center — Houston

Публикации

• 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 C PMID 39425032
• 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 [Pr PMID 38746205

Идентификаторы

NCT: NCT05491213 · 132207 · Pro2022000340 · 1R01HL158850-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗