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Набор по приглашению NCT05407844

Community Health Worker Based Intervention to Improve Palliative Care

Без фазы С лечением Cancer End Stage Cancer Malignancy Advanced Cancer

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: Community Health Worker (CHW) based palliative care.
Кому может быть актуально
Состояния в реестре: Cancer, End Stage Cancer, Malignancy, Advanced Cancer. 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 →

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Обзор

The study aims to find out if community health worker (CHW) support will improve palliative care outcomes in African American patients with advanced cancer, by comparing the quality of life of patients who are receiving standard care to those whose standard care is supplemented with CHW support.

Подробное описание

This research is being done to establish the effectiveness of a Community Health Worker based palliative care intervention among African American patients with advanced solid organ malignancies and their care givers.

The investigators' long-term goal is to reduce the research-to-practice gap in utilization of evidence-based palliative care (PC) in African Americans with advanced cancer. The objectives of this study are to establish the effectiveness of a CHW-based palliative care intervention and develop generalizable knowledge on how contextual factors influence implementation.

Вмешательства

  • Другое Community Health Worker (CHW) based palliative care
    Those in the intervention group will receive support from a dedicated CHW trained in motivational interviewing, components of palliative care communication, and social determinants of health.

Первичные конечные точки

  • Number of participants who completed Advance Directives [Срок оценки: 6 months after enrollment]
Вторичные конечные точки (6)
  • Functional Assessment of Chronic Illness Therapy-Palliative Subscale (FACIT-PAL) score [Срок оценки: 6 months after enrollment]
  • Number of participants who utilize hospice care [Срок оценки: 6 months after enrollment]
  • Goals of care as assessed by Quality of communication (QOC) scale [Срок оценки: 6 months after enrollment]
  • Symptom Intensity as assessed by the Edmonton Symptom Assessment Score (ESAS) [Срок оценки: 6 months after enrollment]
  • Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D) [Срок оценки: 6 months after enrollment]
  • Quality of life assessed by the 5-Level EuroQol 5-Dimensional (EQ-5D-5L) [Срок оценки: 6 months after enrollment]

Критерии участия

Patient Inclusion Criteria:

  • Self-identified African American patients with advanced (AJCC stage III or IV) solid organ malignancy
  • >=18 years old
  • English speaking
  • Intact cognition and ability to provide informed consent

Patient Exclusion Criteria:

  • Participants < 18 years of age
  • Participants who are already receiving palliative care services

Caregiver Inclusion Criteria:

  • Adult (>=18 years old) caregivers providing informal (unpaid) care to an eligible African American cancer patient (related or unrelated)
  • English speaking
  • Intact cognition and ability to provide informed consent

Caregiver Exclusion Criteria:

  • Participants < 18 years of age

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
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 4 центра
  • University of Alabama at Birmingham — Birmingham
  • Johns Hopkins University School of Medicine — Baltimore
  • TidalHealth Peninsula Regional, Inc. — Salisbury
  • Atrium Health Wake Forest Baptist — Winston-Salem

Публикации

  • Johnston FM, Neiman JH, Parmley LE, Conca-Cheng A, Freund KM, Concannon TW, Smith TJ, Cooper LA. Stakeholder Perspectives on the Use of Community Health Workers To Improve Palliative Care Use by African Americans with Cancer. J Palliat Med. 2019 Mar;22(3):302-306. doi: 10.1089/jpm.2018.0366. Epub 2018 Nov 2. PMID 30388060
  • Monton O, Drabo EF, Masroor T, Fuller S, Woods AP, Siddiqi A, Malone TB, Johnston FM. Economic evaluation of a hybrid type 1 effectiveness-implementation trial comparing a community health worker palliative care intervention to enhanced standard of care in African American patients across four cancer centres in the USA: a study protocol. BMJ Open. 2025 Nov 4;15(11):e096402. doi: 10.1136/bmjopen-20 PMID 41193212
  • Siddiqi A, Monton O, Woods A, Masroor T, Fuller S, Owczarzak J, Yenokyan G, Cooper LA, Freund KM, Smith TJ, Kutner JS, Colborn KL, Joyner R, Elk R, Johnston FM. Dissemination and Implementation of a Community Health Worker Intervention for Disparities in Palliative Care (DeCIDE PC): a study protocol for a hybrid type 1 randomized controlled trial. BMC Palliat Care. 2023 Sep 18;22(1):139. doi: 10.1 PMID 37718442

Идентификаторы

NCT: NCT05407844 · IRB00119097 · 1R01CA252101-01A1 · 1R01MD016935-01 · IRB00283002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗