Targeted Palliative Care Intervention for Patients With Metastatic Breast Cancer

Официальное название

Randomized Trial of a Targeted Palliative Care Intervention for Patients With Metastatic Breast Cancer

Обзор

Many people living with metastatic breast cancer face challenging symptoms and frequent medical visits. At the same time, conversations about personal goals, values, and preferences for care may not always happen as early or as often as patients and families would like. This multi-site study will test the effectiveness of a five-session palliative care program, designed specifically for people with metastatic breast cancer and their caregivers, to strengthen communication with clinicians about what matters most in their care. The study aims to inform how palliative care services can be delivered in a more timely, personalized, and scalable way for people living with advanced cancers who have long disease trajectories, such as metastatic breast cancer.

Подробное описание

The diagnosis of metastatic breast cancer can bring many challenges including physical symptoms, treatment side effects, and emotional stress for patients and their families. Palliative care specialists work alongside the oncology team to help patients and families manage symptoms, communicate effectively with their clinicians, and cope with the impact of living with cancer.

Research has shown that when palliative care and oncology teams collaborate closely, patients often experience better symptom relief, clearer communication about their goals and preferences, improved quality of life and mood, and a stronger understanding of their illness. Caregivers also report feeling more supported and less distressed.

The purpose of this research study is to learn whether a personalized palliative care program for people with metastatic breast cancer and their caregivers, called TARGET-PC, can further improve communication, symptom management, coping skills, and understanding of care.

In this study, 400 patients with metastatic breast cancer and their caregivers will be randomly assigned to receive either the TARGET-PC program or enhanced usual care. Enhanced usual care includes an electronic prompt that reminds oncology clinicians to discuss and record each patient's goals and preferences for care. The study will take place at the Massachusetts General Hospital Cancer Center, Penn Abramson Cancer Center, and Duke Cancer Center.

Вмешательства

• Другое Palliative Care Intervention, "TARGET-PC"
  Palliative care intervention focused on eliciting patients' goals and values to facilitate discussion and documentation of health care preferences.
• Другое Enhanced Usual Care
  Oncology clinicians will receive an electronic message to encourage them to discuss and document their patients' health care preferences.

Первичные конечные точки

• Documentation of End-of-Life Care Preferences [Срок оценки: From date of randomization until date of death or last follow up assessed up to 60 months]

Вторичные конечные точки (4)

• Hospice Utilization [Срок оценки: From date of randomization until date of death or last follow up assessed up to 60 months]
• Hospice Length of Stay [Срок оценки: From date of randomization until date of death or last follow up assessed up to 60 months]
• Death in the Hospital [Срок оценки: From date of randomization until date of death or last follow up assessed up to 60 months]
• Patient-reported Communication about End-of-Life Care Preferences [Срок оценки: From date of randomization until date of death or last follow up assessed up to 60 months]

Критерии участия

Patient Inclusion Criteria:

• age ≥18 years
• diagnosed with metastatic breast cancer
• within 8 weeks of the oncology visit at which they were identified as having an eligible Epic EOL Care Index (≥ 15)
• functioning independently per an Eastern Cooperative Oncology Group performance status ≤2
• receiving their cancer care at one of the participating institutions
• able to complete questionnaires in English or Spanish

Patient Exclusion Criteria:

• received outpatient palliative care visit within the last six months
• enrolled in hospice services
• diagnosed with a comorbid condition that impairs their ability to understand study procedures and/or consent for the trial as per the report of the oncology clinician(s)

Caregiver Inclusion Criteria:

• age ≥18 years
• identified by the patient as a family member or friend who is primarily involved in their care
• able to complete questionnaires in English or Spanish

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

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 3 центра

• Massachusetts General Hospital — Boston
• Duke University — Durham
• University of Pennsylvania — Philadelphia

Публикации

• Greer JA, Moy B, El-Jawahri A, Jackson VA, Kamdar M, Jacobsen J, Lindvall C, Shin JA, Rinaldi S, Carlson HA, Sousa A, Gallagher ER, Li Z, Moran S, Ruddy M, Anand MV, Carp JE, Temel JS. Randomized Trial of a Palliative Care Intervention to Improve End-of-Life Care Discussions in Patients With Metastatic Breast Cancer. J Natl Compr Canc Netw. 2022 Feb;20(2):136-143. doi: 10.6004/jnccn.2021.7040. PMID 35130492

Идентификаторы

NCT: NCT06795529 · 24-723 · R01CA299956

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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