A Telehealth Advance Care Planning Intervention
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: Telehealth Serious Illness Care Program, Education Control.
- Кому может быть актуально
- Состояния в реестре: Myeloid Malignancy, Acute Myeloid Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasm. Базовые параметры: от 60 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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Официальное название
A Telehealth Advance Care Planning Intervention for Older Patients With Myeloid Malignancies: A Pilot Randomized Controlled Trial
Обзор
The objective of this project is to conduct a pilot randomized trial to assess the preliminary efficacy of a telehealth-delivered Serious Illness Care Program on healthcare communication, patient anxiety and distress, as well as completion of advance directives (specifically MOLST and healthcare proxy forms) for older patients with acute myeloid leukemia, myelodysplastic syndrome, and similar myeloid malignancies.
Подробное описание
The Serious Illness Care Program (SICP) is an evidence-based intervention to enhance serious illness conversations between physicians and patients with advanced cancer. It consists of the Serious Illness Conversation Guide as well as training and system-level support for clinicians to conduct serious illness conversations. The investigators have previously adapted the SICP to be delivered via telehealth for older adults with myeloid malignancies. In this study, they will conduct a pilot randomized trial to assess the preliminary efficacy of a telehealth-delivered Serious Illness Care Program compared to an education control.
Вмешательства
- Поведенческое Telehealth Serious Illness Care Program
The adapted telehealth Serious Illness Care Program is a multilevel intervention engaging the patient, caregiver, clinician, and system. It consists of tools, training, and system change. Tools include: 1) The Serious Illness Conversation Guide for clinicians; and 2) Education materials for patients on the importance of Serious Illness Conversations (Patient Preparation Pamphlet) and of the involvement of caregivers (Family Communication Guide). - Другое Education Control
Education materials developed by the NCI on "Communication in Cancer Care (PDQ®) - Patient Version"
Первичные конечные точки
- Healthcare Communication: Health Care Climate Questionnaire [Срок оценки: Month 2]
Вторичные конечные точки (3)
- Distress: Distress Thermometer [Срок оценки: Month 2]
- Anxiety Symptoms: Generalized Anxiety Disorder-7 (GAD-7) [Срок оценки: Month 2]
- Completion of advance directives [Срок оценки: Throughout the study, up to 2 years]
Критерии участия
Inclusion and Exclusion Criteria for Patients
Критерии включения
- Age ≥60 years
- A diagnosis of AML, MDS, and similar myeloid malignancies (including but not limited to MDS/MPN overlap syndrome, myelofibrosis)
- Being managed in the outpatient settings
- Able to provide informed consent
- English-speaking
Критерии исключения
\- None
Inclusion and Exclusion Criteria for Caregivers
Критерии включения
- Age ≥18 years
- Selected by patient when asked if there is a "family member, partner, friend, or caregiver with whom you discuss or who can be helpful in health-related matters"
- Able to provide informed consent
- English-speaking
Критерии исключения
\- None
Inclusion and Exclusion Criteria for Oncology Providers
Критерии включения
\- Oncologists and/or APPs who will be conducting the telehealth-delivered ACP visit
Критерии исключения
\- None
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 · 1 центр
- University of Rochester — Rochester
Публикации
- LoCastro M, Sanapala C, Mendler JH, Norton S, Bernacki R, Carroll T, Klepin HD, Watson E, Liesveld J, Huselton E, O'Dwyer K, Baran A, Flannery M, Kluger B, Loh KP. Adaptation of Serious Illness Care Program to be delivered via telehealth for older patients with hematologic malignancy. Blood Adv. 2023 May 9;7(9):1871-1884. doi: 10.1182/bloodadvances.2022008996. PMID 36521100
- LoCastro M, Sanapala C, Mendler JH, Norton S, Bernacki R, Carroll T, Klepin H, Watson E, Liesveld J, Huselton E, O'Dwyer K, Baran A, Flannery M, Kluger BM, Loh KP. Advance care planning in older patients with acute myeloid leukemia and myelodysplastic syndromes. J Geriatr Oncol. 2023 Jan;14(1):101374. doi: 10.1016/j.jgo.2022.09.003. Epub 2022 Sep 10. PMID 36100548
Идентификаторы
NCT: NCT05875805 · UOCPC23038