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Идёт набор NCT05857995

Precision Lung Cancer Survivorship Care Intervention

Без фазы С лечением Lung Cancer Pulmonary Neoplasm Neoplasms, Lung Neoplasms, Pulmonary

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program, Enhanced Usual Care.
Кому может быть актуально
Состояния в реестре: Lung Cancer, Pulmonary Neoplasm, Neoplasms, Lung, Neoplasms, Pulmonary. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Precision Lung Cancer Survivorship Care Intervention: A Randomized Controlled Trial Serving Rural Survivors and Communities

Обзор

The overarching goal of the Kentucky LEADS Collaborative Lung Cancer Survivorship Care program is to reduce the burden of lung cancer by offering an innovative survivorship care approach that improves lung cancer quality of life, overcomes lung cancer stigma, and helps survivors engage with care. The project involves a two-group parallel randomized clinical trial comparing the impact of the Kentucky LEADS Collaborative Lung Cancer Survivorship Care program (KLCLCSC) among lung cancer survivors (N=300) against an enhanced usual care condition (bibliotherapy+assessment) on quality of life outcomes.

Подробное описание

Among the devastating illnesses impacting rural America, few exact the physical, social, psychological, and economic toll of lung cancer. Lung cancer is the leading cause of cancer death in rural America, and the levy is particularly acute in Kentucky - a state that not only leads the nation in lung cancer incidence and mortality but is a global epicenter of lung cancer. Despite the prevailing nihilism regarding lung cancer care, lung cancer survivors are living longer. Innovations in prevention, early detection, and treatment, have created substantial optimism and opportunities for long-term lung cancer survivorship. These dramatic changes in the lung cancer care landscape have invigorated the need for quality lung cancer survivorship interventions. The overarching goal of the Kentucky LEADS Collaborative Lung Cancer Survivorship Care program is to reduce the burden of lung cancer by offering an innovative survivorship care approach that improves lung cancer quality of life, overcomes lung cancer stigma, and helps survivors engage with care. Using a novel precision survivorship approach and developed in collaboration with rural community stakeholders, the program's foundation incorporates principles of patient-centered care, shared decision making, and motivational interviewing to build survivor engagement. A large acceptability and feasibility trial conducted in collaboration with nine lung cancer care facilities in Kentucky with lung cancer survivors (N=140) demonstrated the acceptability of the intervention among survivors, caregivers, and lung cancer care clinicians. The study also revealed the feasibility of conducting the proposed study methods in rural cancer care facilities. The project continues this program of research by conducting a two-group parallel randomized clinical trial comparing the impact of the Kentucky LEADS Collaborative Lung Cancer Survivorship Care program (KLCLCSC) among lung cancer survivors (N=300) against an enhanced usual care condition (bibliotherapy+assessment) on quality of life outcomes. Rural-residing lung cancer survivors will be recruited from ten oncology care facilities throughout Kentucky. The project's first aim compares the efficacy of the interventions with regard to lung cancer quality of life among survivors as measured by the FACT-L and other rigorous assessments of patient engagement, symptom burden, psychosocial well-being, and behavior change. The project's second aim evaluates the moderating impact of including caregivers as intervention partners on survivor quality of life outcomes. A third aim evaluates the cost-effectiveness of the KLCLCSC intervention in comparison to the enhanced usual care condition. Based on highly encouraging pilot data collected in collaboration with oncology care programs in Kentucky, this research holds credible potential to establish a new paradigm for addressing the challenges associated with lung cancer and for delivering quality survivorship care to rural-residing, economically distressed lung cancer survivors.

Вмешательства

  • Поведенческое Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program
    KLCLCSC is a survivor or survivor plus caregiver-focused psychosocial and behavioral intervention designed to engage lung cancer survivors and improve lung cancer outcomes.
  • Поведенческое Enhanced Usual Care
    EUC involves a combination of the standard of care plus a bibliotherapy intervention and assessment.

Первичные конечные точки

  • Change from Baseline (T0) in Mean Lung Cancer Quality of Life at 6 Months (T2) [Срок оценки: Baseline (T0) and 6 Months (T2)]
Вторичные конечные точки (12)
  • Change from Baseline (T0) in Total Survivor Engagement at 6 Months (T2) [Срок оценки: Baseline (T0) and 6 Months (T2)]
  • Change from Baseline (T0) in Mean Lung Cancer Knowledge at 6 Months (T2) [Срок оценки: Baseline (T0) and 6 Months (T2)]
  • Change from Baseline (T0) in Mean Fatigue Symptoms at 6 Months (T2) [Срок оценки: Baseline (T0) and 6 Months (T2)]
  • Change from Baseline (T0) in Mean Sleep Disturbance at 6 Months (T2) [Срок оценки: Baseline (T0) and 6 Months (T2)]
  • Change from Baseline (T0) in Pulmonary Symptoms at 6 Months (T2) [Срок оценки: Baseline (T0) and 6 Months (T2)]
  • Change from Baseline (T0) in Mean Pain Interference at 6 Months (T2) [Срок оценки: Baseline (T0) and 6 Months (T2)]
  • Change from Baseline (T0) in Mean Emotional Social Support at 6 Months (T2) [Срок оценки: Baseline (T0) and 6 Months (T2)]
  • Change from Baseline (T0) in Mean Knowledge of Palliative Care at 6 Months (T2) [Срок оценки: Baseline (T0) and 6 Months (T2)]
  • Change from Baseline (T0) in Psychological Distress at 6 Months (T2) [Срок оценки: Baseline (T0) and 6 Months (T2)]
  • Change from Baseline (T0) in Mean Physical Activity at 6 Months (T2) [Срок оценки: Baseline (T0) and 6 Months (T2)]
  • Change from Baseline (T0) in Smoking Status at 6 Months (T2) [Срок оценки: Baseline (T0) and 6 Months (T2)]
  • Change from Baseline (T0) in Lung Cancer Stigma at 6 Months (T2) [Срок оценки: Baseline (T0) and 6 Months (T2)]

Критерии участия

Критерии включения

  • Have been diagnosed with lung cancer
  • Reside in a rural county as determined by a Rural Urban Continuum Code (RUC) of 4 or higher
  • Be at least 18 years of age or older
  • Be able to communicate effectively in English

Критерии исключения

  • Have significant psychiatric disturbance that requires a higher level of care
  • Have substance abuse/dependence that requires a higher level of care
  • Are participating in another lung cancer survivorship care intervention
  • Have previously participated in the Kentucky LEADS Lung Cancer Survivorship Care Program

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • Markey Cancer Center — Lexington

Идентификаторы

NCT: NCT05857995 · 94571 · R01CA254734

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗