Tailored Patient Navigation to Improve the Uptake of Lung Cancer Screening in Tribal Communities in Western Washington State, SACRED LUNGS Trial

Официальное название

Strengthening Awareness and Community Resources for Early Detection of Lung Cancer Through Navigation Guided Screening Trial (SACRED LUNGS Aims 1.2-3)

Обзор

This clinical trial studies whether tailored patient navigation (PN) works to improve the uptake of lung cancer screening (LCS) in tribal communities in western Washington state. Lung cancer is the leading cause of cancer death in the United States among American Indian (AI) and Alaska Native (AN) people, and the incidence of lung cancer is higher in this population in the Northern and Southern Plains, Alaska, and Pacific Coast regions. In Washington state, AI/AN people also have twice the rate of commercial cigarette smoking than the overall population. LCS with annual low-dose chest computed tomography (CT) can reduce lung cancer death and is recommended in people 50-80 years of age with current or recent (within 15 years) tobacco use and a 20 pack-year or greater smoking history. Despite this, AI and AN people are less likely to receive LCS which may be due to barriers they face making it difficult to receive LCS. PN services are designed to guide a patient through the healthcare system and reduce barriers to timely screening, follow-up, diagnosis, treatment, and supportive care. The PN services in this trial have been tailored for the tribal communities in western Washington state. The services are designed to help participants overcome the unique barriers that their tribal communities face and improve the uptake of LCS.

Подробное описание

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM 1: Participants receive tailored PN activities in support of the uptake and follow-up of LCS for 21 months. Participants also receive an educational handout on LCS on study.

ARM 2: Participants receive enhanced usual care consisting of an educational handout on LCS and a warm hand-off to discuss LCS with their primary care physician (PCP) for 6 months. Participants then receive tailored PN services in support of the uptake and follow-up of LCS for 15 months.

Вмешательства

• Поведенческое Patient Navigation
  Receive tailored PN activities
• Другое Educational Intervention
  Receive LCS educational handout
• Другое Best Practice
  Receive enhanced usual care
• Другое Interview
  Ancillary studies
• Другое Survey Administration
  Ancillary studies
• Другое Electronic Health Record Review
  Ancillary studies

Первичные конечные точки

• Completion of chest computed tomography (CT) (Aim 1.2) [Срок оценки: Up to 6 months]

Вторичные конечные точки (8)

• Completion of low dose computed tomography of the chest (Aim 1.2) [Срок оценки: Up to 21 months]
• Lung cancer screening (LCS) knowledge (Aim 1.2) [Срок оценки: At 21 months]
• Health-related quality of life (Aim 1.2) [Срок оценки: At 21 months]
• Rate of reported 30-day cessation period (Aim 1.2) [Срок оценки: Up to 6 months]
• Completion of chest CT (Aim 2) [Срок оценки: Up to 6 months]
• Navigation care engagement (Aim 2) [Срок оценки: Up to 21 months]
• Completion of chest CT (Aim 3) [Срок оценки: Up to 15 months]
• Completion of next diagnostic step in LCS follow-up [Срок оценки: Up to 15 months]

Критерии участия

Критерии включения

• AIM 1.2 RANDOMIZED CONTROLLED TRIAL: Between ages 50-77
• AIM 1.2 RANDOMIZED CONTROLLED TRIAL: Self-reported 20-pack year smoking history
• AIM 1.2 RANDOMIZED CONTROLLED TRIAL: Ongoing commercial tobacco use within the past 15 years
• AIM 1.2 RANDOMIZED CONTROLLED TRIAL: Seen by a PCP at a participating clinic (South Puget Intertribal Planning Agency \[SPIPA\] or Muckleshoot) within the past three years

• Potential participants who want to establish care at an eligible clinic will be connected to a PCP
• AIM 2 CLINICAL STAFF SURVEYS AND SEMI-STRUCTURED INTERVIEWS: At least 18 years of age
• AIM 2 CLINICAL STAFF SURVEYS AND SEMI-STRUCTURED INTERVIEWS: Affiliation with Muckleshoot or SPIPA (one of the 6 community partnering clinics) as a provider, or supportive staff member
• AIM 2 PATIENT SURVEYS AND SEMI-STRUCTURED INTERVIEWS: Patient participated in the aim 1.2 trial
• AIM 3 CLINICAL STAFF SURVEYS AND SEMI-STRUCTURED INTERVIEWS: At least 18 years of age
• AIM 3 CLINICAL STAFF SURVEYS AND SEMI-STRUCTURED INTERVIEWS: Affiliation with Muckleshoot or SPIPA (one of the 6 community partnering clinics) as a provider, or supportive staff member
• AIM 3 PATIENT SURVEYS AND SEMI-STRUCTURED INTERVIEWS: Patient participated in the aim 1.2 trial

Критерии исключения

• AIM 1.2 RANDOMIZED CONTROLLED TRIAL: Has had a documented chest CT within the past one year
• AIM 1.2 RANDOMIZED CONTROLLED TRIAL: Personal history of lung cancer or symptoms associated with lung cancer

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

Простое слепое

Основная цель

Скрининг

Центры проведения

США · 2 центра

• Muckleshoot Tribal Clinic — Auburn
• South Puget Intertribal Planning Agency (SPIPA) — Shelton

Публикации

• Triplette M, Walsh C, Shah PD, Hippe DS, Louie T, Anderson N, Long S, Omernik B, Schwartz J, Nelson L, Parker M, Mendoza J, Nikander J, Ramachandran M, Carey A, Tsosie U. Strengthening awareness and community resources for early detection of lung cancer through navigation guided screening in American Indian/Alaska Native clinics (SACRED LUNGS): Study protocol. Contemp Clin Trials. 2026 Jul 20:1084 PMID 42476254

Идентификаторы

NCT: NCT07176000 · RG1125421 · NCI-2025-06016 · FHIRB0020813 · U19MD020533

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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