Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With 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: Receive technology-based supportive cancer care, Receive redesigned team-based supportive cancer care.
- Кому может быть актуально
- Состояния в реестре: End of Life, 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
This cluster-randomized comparative effectiveness trial compares a technology-based supportive cancer care (SCC) approach with a redesigned team-based supportive cancer care (SCC) approach.
Подробное описание
PRIMARY OBJECTIVES:
I. Greater intervention effects on health-related quality of life
SECONDARY OBJECTIVES:
I. Greater intervention effects on patient activation II. Greater satisfaction with care and decision-making III. Greater documentation of goals of care and symptoms IV. To lower acute care V. Greater palliative care and hospice
OUTLINE: Sites are randomized to 1 of 2 arms.
ARM A: Patients receive educational materials to assist with advance care planning and symptom management through a technology-based supportive cancer care weekly during months 1-4 and every other week during months 5-12.
ARM B: Patients are paired with a lay health worker who will discuss the same educational materials from ARM A either in person or by telephone discussions weekly during months 1-4 and every other week during months 5-12.
All participants complete a baseline interview upon enrollment during the initial consent phone contact and then a survey at 3-, 6-and 12-months post enrollment.
Вмешательства
- Другое Receive technology-based supportive cancer care
All participants will receive an electronic health record message or email with standardized information provided regarding advance care planning and symptom management. - Поведенческое Receive redesigned team-based supportive cancer care
Lay Health Workers will meet with 1:1 with participants over 12 months to discuss advance care planning, surrogate decision-makers, advance directives and physician orders for life sustaining treatment.
Первичные конечные точки
- Change in health-related quality of life as assessed by the Functional Assessment of Cancer Therapy (FACT-G). [Срок оценки: Change in health-related quality of life from baseline to 3 months]
Вторичные конечные точки (10)
- Change in health-related quality of life as assessed by the Functional Assessment of Cancer Therapy (FACT-G). [Срок оценки: Change in health-related quality of life from baseline to 6, and 12 months]
- Change in patient activation using the Patient Activation Measure (PAM-13). [Срок оценки: Change in patient activation from baseline to 3, 6, and 12 months]
- Change in satisfaction with care using the Consumer Assessment of Health Care (Providers and Systems (CAHPS) Cancer Care Survey Questions #39 and #42. [Срок оценки: Change in satisfaction with care from baseline to 3, 6, and 12 months]
- Change in satisfaction with decision using the Satisfaction with Decision Scale (SWD) [Срок оценки: Change in satisfaction with decision from baseline to 3, 6, and 12 months]
- Palliative Care Use (Self-reported and Chart Review) [Срок оценки: 3, 6, and 12 months after patient enrollment]
- Hospice Care Use (Self-reported and Chart Review) [Срок оценки: 3, 6, and 12 months after patient enrollment]
- Emergency Department Visits (Self-reported and Chart Review) [Срок оценки: 3, 6, and 12 months after patient enrollment]
- Hospitalization Visits (Self-reported and Chart Review) [Срок оценки: 3, 6, and 12 months after patient enrollment]
- Documentation of goals of care discussions (Chart Review) [Срок оценки: 3, 6, and 12 months after patient enrollment]
- Documentation of symptom discussions (Chart Review) [Срок оценки: 3, 6, and 12 months after patient enrollment]
Критерии участия
Критерии включения
- Newly diagnosed patients with solid tumor cancer diagnosis or recurrence of the disease.
- Patients must have the ability to understand and willingness to provide verbal consent.
- Participants must speak English, Spanish, Chinese, or Vietnamese.
Критерии исключения
- Inability to consent to the study
- Plans to change oncologist within 12 months
- Employed by the practice site
- Patients who anticipate moving from the area within 12 months
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
- Простое слепое
- Основная цель
- Организация здравоохранения
Центры проведения
США · 17 центров
- University of Alabama at Birmingham — Birmingham
- University of South Alabama — Mobile
- Beckman Research Institute of City of Hope — Duarte
- VA Medical Center, Fresno — Fresno
- Santa Clara Valley Medical Center — Fruitdale
- St Jude Heritage Medical Group — Fullerton
- Oncology Institute for Hope and Innovation — Los Angeles
- Sacramento VA Medical Center - VA Northern California Health Care System — Mather
- … и ещё 9 центров
Идентификаторы
NCT: NCT05297734 · 63646