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Идёт набор NCT05646576

Defining the Role of Palliative carE for Patients With Hematologic Malignancies Undergoing Adoptive CEllular Therapy

Без фазы С лечением Hematologic Malignancy Blood Cancer Lymphoma Leukemia

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: Palliative Care, Usual Care.
Кому может быть актуально
Состояния в реестре: Hematologic Malignancy, Blood Cancer, Lymphoma, Leukemia. 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
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Официальное название

Defining the Role of Palliative carE for Patients With Hematologic Malignancies Undergoing Adoptive CEllular Therapy: The PEACE Study

Обзор

The goal of this study is to determine whether a palliative care intervention (PEACE) can improve the quality of life and experiences of participants with Lymphoma, Leukemia, or Multiple Myeloma receiving adoptive cellular therapy (ACT). After completion of an open pilot, participants will be randomly assigned into one of two study intervention groups. The names of the study intervention groups involved in this study are: * Palliative care (PEACE) plus usual oncology care * Usual care (standard oncology care) Participation in this research study is expected to last for up to 2 years. It is expected that about 90 people will take part in this research study.

Подробное описание

This is a single-center, parallel-group, randomized controlled study to determine whether a palliative care intervention (PEACE) can improve the quality of life and experiences of participants with Lymphoma, Leukemia, or Multiple Myeloma receiving adoptive cellular therapy (ACT).

10 participants with planned ACT will be enrolled into an open pilot and will receive a palliative care intervention (PEACE) for the duration of treatment. Once the palliative care intervention has been refined by feedback from the pilot participants, the study will enroll 80 participants and will randomly assign the participants into one of two study intervention groups. Randomization means that a participant is put into a group by chance.

The names of the study intervention groups involved in this study are:

* Palliative care intervention (PEACE) plus usual oncology care * Usual care (standard oncology care)

Participation in this research study is expected to last for up to 2 years.

It is expected that about 90 people will take part in this research study.

The American Society of Clinical Oncology is supporting this research study by providing funding support.

Вмешательства

  • Поведенческое Palliative Care
    * Palliative care (PC) intervention tailored to ACT recipients and addressing multiple PC domains with the input of ACT clinical experts, PC clinicians, and patients and caregivers. * Domains discussed include therapeutic relationship, symptom management, prognostic awareness and illness understanding, coping with illness, treatment decision-making, EOL care. * The palliative care intervention will be refined for the randomized control trial based on the feedback from the open pilot.
  • Поведенческое Usual Care
    Standard care for ACT per the treating team.

Первичные конечные точки

  • Percentage of Eligible Participants Enrolled to Palliative Care Intervention (PEACE) (Feasibility) [Срок оценки: 1 day]
Вторичные конечные точки (9)
  • Acceptability [Срок оценки: Up to Day 90]
  • Quality of Life - FACT-G [Срок оценки: Baseline to day 90]
  • Anxiety Symptoms [Срок оценки: Baseline to day 90]
  • Depression Symptoms [Срок оценки: Baseline to day 90]
  • Post-Traumatic Stress Disorder (PTSD) Symptoms [Срок оценки: Baseline to day 90]
  • Physical Symptom Burden [Срок оценки: Baseline to day 90]
  • Coping [Срок оценки: Baseline to day 90]
  • Prognostic Understanding [Срок оценки: Baseline to day 90]
  • End-of-Life Communication [Срок оценки: Baseline to day 90]

Критерии участия

Критерии включения

  • Age 18 years or older.
  • Ability to complete surveys in English or with assistance of an interpreter.
  • Diagnosis of a hematologic malignancy.
  • Receiving autologous adoptive cellular therapy (ACT) at MGH with an FDA approved cellular therapy product.

Критерии исключения

  • Impaired cognition or uncontrolled mental illness that prohibits study compliance based on the oncology clinician assessment.
  • Already receiving palliative care (PC).

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
  • Massachusetts General Hospital Cancer Center — Boston

Идентификаторы

NCT: NCT05646576 · 22-487

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗