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Идёт набор NCT04984551

Impact of Project ECHO on Improving the Quality of Palliative Care in Patients With Advanced Cancer and Their Caregivers in Underserved Areas of Kenya, Nigeria, Ghana, South Africa, India, and Ethiopia

Фаза II С лечением Advanced Malignant Solid Neoplasm Hematopoietic and Lymphoid Cell Neoplasm

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: Extension of Community Health (ECHO) Telementoring Clinic, In-Country Workshops, Professional Oncology Educations Programs, Medical Chart Review.
Кому может быть актуально
Состояния в реестре: Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm. Базовые параметры: Без ограничений · 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

ECHO Telementoring to Improve Quality Palliative Care in Underserved Areas of Kenya, Nigeria, Ghana, South Africa, India, and Ethiopia

Обзор

This trial investigates the experience and satisfaction of care in patients with cancer that has spread to other places in the body (advanced) and their caregivers living in underserved areas of Kenya, Nigeria, Ghana, South Africa, India and Ethiopia as part of Project Extension for Community Healthcare Outcomes (ECHO). Project ECHO is a model of medical education and care management that empowers clinicians to provide better care to more people where they live. Understanding the experiences and satisfaction of patients and caregivers may help improve healthcare workforce capacity and increase access to specialty care for the world's rural and underserved populations.

Подробное описание

PRIMARY OBJECTIVE:

I. To evaluate the effects of Project ECHO on patient-reported quality of life (QOL) (as assessed by the change in Functional Assessment of Cancer Illness Therapy FACT-General \[G\]) in seriously ill patients of providers receiving ECHO model-based comprehensive educational and telementoring intervention (ECHO-Palliative Care, or ECHO-PCT).

SECONDARY/EXPLORATORY OBJECTIVES:

I. To examine the effects of ECHO-PCT on patients' symptom distress as assessed by the Edmonton Symptom Assessment Scale (ESAS), Symptom Distress Scores (SDS), as well as patient and caregiver experience and satisfaction as assessed by the FAMCARE-P 16-item (16)-patient and FAMCARE-caregiver questionnaires.

II. To explore the effects of ECHO-PCT on providers' efficacy in, knowledge of, and competence to deliver Palliative Care to Patients with serious life limiting illness, as well as their satisfaction with providing Palliative Care services as assessed by Palliative Care Participant Initial Survey, Palliative Care Participant Follow Up Survey, and Feedback Survey.

IIa. Increase patient access to quality palliative care in these regions (morphine consumption).

IIb. Increase patient access to quality palliative care in these regions (morphine consumption).

IIc. Increased patient access to palliative care (PC) measured by the number of patient visits (new and follow-ups).

IId. Provider turnover. IIe. Adherence, measured by the number of ECHO sessions held, the number of ECHO participants at each session, and the number of cases reviewed.

IIf. Comfort with the ECHO platform and ability to learn/engage via distance technology, assessed by the Palliative Care Participant Initial Survey and Palliative Care Participant Follow Up Survey.

OUTLINE: Participants are assigned to 1 of 3 arms.

ARM I (ECHO PARTICIPANTS): Participants participate in online ECHO clinics over 1 hour twice monthly for 12 months and in-country workshops twice per year. Participants complete 5 online surveys between baseline through end of year 2 for up to a total of 26 minutes .Participants complete a 15-minute interview in person or phone about their experience in the ECHO project.

ARM II (PATIENTS): Patients complete 3 in-person or phone questionnaires over a total of 20 minutes every 3 months for 2 years about their symptoms, emotional and physical well-being, and their experience and satisfaction with outpatient oncology care. Patients' medical charts are reviewed for data collection. Patients complete a 15-minute interview in person or phone about their care received by their physician at baseline, end of month 4 and month 12.

ARM III (CAREGIVERS): Caregivers complete an in-person or phone questionnaire over 5 minutes up to 8 times about their experience and satisfaction with the cancer care their family member has received. Caregivers complete a 15 minute interview in person or by phone about the care their family member received by their physician.

Вмешательства

  • Другое Extension of Community Health (ECHO) Telementoring Clinic
    Participate in ECHO clinics presenting cases for guidance and feedback
  • Другое In-Country Workshops
    In-Country Workshops Participate in hands-on training and workshops
  • Другое Professional Oncology Educations Programs
    Receive 5 core online lectures
  • Другое Medical Chart Review
    Medical charts are reviewed for data collection
  • Другое Questionnaire Administration
    Complete questionnaire(s)

Первичные конечные точки

  • Change in patients' quality of life [Срок оценки: Baseline up to 12 months]
Вторичные конечные точки (8)
  • Change in patients' symptom distress [Срок оценки: Baseline up to 2 years]
  • Patients' satisfaction of care [Срок оценки: Baseline up to 2 years.]
  • Caregivers' satisfaction of care [Срок оценки: Baseline up to 2 years]
  • Providers' efficacy in knowledge of delivering palliative care [Срок оценки: Baseline]
  • Providers' efficacy in knowledge of delivering palliative care [Срок оценки: Up to 2 years]
  • Providers' competence to deliver palliative care [Срок оценки: Baseline up to 2 years]
  • Providers' Satisfaction and feedback [Срок оценки: Baseline up to 2 years]
  • Burnout among ECHO participant [Срок оценки: Baseline up to 2 years]

Критерии участия

Критерии включения

  • PATIENT: Scheduled to receive treatment at participating primary care practice for advanced cancer
  • PATIENT: 18 years or older
  • PATIENT: Willing to be accessible to the research team for follow-up by telephone or in person
  • PATIENT: Prognosis of at least 1 year as ascertained by the treating physician
  • PATIENT: Able to read and understand English as assessed by the treating physician
  • CAREGIVER: Identified or self-identified as primary caregiver of the patient
  • CAREGIVER: Willing to be accessible to the research team for follow-up by telephone or in person
  • CAREGIVER: 18 years or older
  • CAREGIVER: Able to read and understand English as assessed by the treating physician
  • ECHO PARTICIPANT: Participant must be a health care provider interested to participate in the study for 2 years and understand the protocol and provide consent
  • ECHO PARTICIPANT: Able to read and understand English as assessed by principal investigator (PI)

Критерии исключения

  • Unable to understand and sign consent

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • M D Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT04984551 · 2019-0462 · NCI-2020-06074 · 2019-0462

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗