Health Education Approach to Lung Screening

Официальное название

Health Education Approach to Lung Screening (HEALS)

Обзор

Evaluate the impact of the patient navigation program on the proportion of patients who complete lung cancer screening (LCS), defined as undergoing a low dose computed tomography (LDCT)

Подробное описание

This is a single-arm study of a patient navigation intervention to increase access to lung cancer screening (LCS).

Вмешательства

• Поведенческое Patient Navigation
  Navigation will address the following 4 domains of barriers to screening: * Individual * Organizational * Economic * Sociocultural At the first visit, navigators will assess the participant's barriers in each of these domains. Any follow-up visits, if necessary, will be used to help the participant overcome these barriers to screening

Первичные конечные точки

• Number of study patients who complete lung cancer screening (LCS) through the patient navigation process [Срок оценки: 2 weeks to 10 months following day 1, varies by participant]

Вторичные конечные точки (6)

• Assess the feasibility and acceptability of the patient navigation program [Срок оценки: Day 1]
• Assess the feasibility and acceptability of the patient navigation program [Срок оценки: 2 weeks to 10 months following day 1, varies by participant]
• Assess the impact of the patient navigation program on patient health-related quality of life at baseline. [Срок оценки: Day 1]
• Assess the impact of the patient navigation program on patient health-related quality of life after navigation intervention. [Срок оценки: 2 weeks to 10 months following day 1, varies by participant]
• Assess the impact of the patient navigation program on patient financial distress [Срок оценки: Day 1]
• Assess the impact of the patient navigation program on patient financial distress [Срок оценки: 2 weeks to 10 months following day 1, varies by participant]

Критерии участия

Критерии включения

• Meets current USPSTF guidelines for lung cancer screening (LCS)
• 20 pack-year smoking history Note: A pack-year is a way of calculating how much a person has smoked in their lifetime.

One pack-year is the equivalent of smoking an average of 20 cigarettes-1 pack-per day for a year.

• Currently smokes or has quit smoking within the past 15 years
• Identifies as Black or African-American Note: Both Hispanic/Latino and Non-Hispanic/Latino patients are eligible as long as they also identify as Black or African-American (eg, Afro-Latino).
• Willing to complete all navigation-related study activities
• Able to understand and the willingness to sign a written informed consent document

Критерии исключения

A patient who meets any of the following exclusion criteria is ineligible to participate in the study:

• Known history of cancer (except squamous cell skin cancer), or coughing up blood in the past 5 years, as reported by the individual
• Has undergone a previous lung cancer screening
• Inability to speak English
• Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

США · 3 центра

• University of North Carolina-Chapel Hill — Carrboro
• Medical University of South Carolina — Charleston
• Virginia Commonwealth University — Richmond

Идентификаторы

NCT: NCT06070870 · SU2C-WINN · HM20026222

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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