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Идёт набор NCT05297734

Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer

Без фазы С лечением End of Life 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 →

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

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗