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Идёт набор NCT06405828

Enhancing Access to Supportive Services for Women of Color With Metastatic Breast Cancer

Без фазы С лечением Metastatic Breast Cancer Stage IV Breast Cancer AJCC V7

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: ACCESS Supportive Care, Phone sessions.
Кому может быть актуально
Состояния в реестре: Metastatic Breast Cancer, Stage IV Breast Cancer AJCC V7. Базовые параметры: от 18 лет · Женщины.
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

Project ACCESS: A Pilot Randomized Controlled Trial of a Navigator Delivered Model to Enhance Access to Supportive Services for Women of Color With Metastatic Breast Cancer

Обзор

Black and Latina women experience disparities in supportive and palliative care access and outcomes. The goal of the proposed pilot study is to evaluate the feasibility and acceptability of a community navigator delivered supportive care intervention for historically underserved populations of women with metastatic breast cancer.

Подробное описание

Primary Objectives:

1. Establish the feasibility and acceptability of an adapted navigator delivered supportive care model called ACCESS to address supportive care needs for Black and Latina women with Metastatic Breast Cancer. 2. Determine the potential impact of ACCESS on cancer related distress, symptom burden, and utilization of supportive care services.

OUTLINE: Participants (N=60) are randomized to 1 of 2 groups:

GROUP 1/Intervention Group: Participants complete 6 individualized behavioral/educational sessions focused on social determinants of health and supportive care with a trained community navigator followed by monthly phone call check ins for 4 months. Participants complete questionnaires over the phone with a research coordinator at baseline, 6 and 9 months.

GROUP 2/Attention Control group: Participants complete 6 phone calls with a research coordinator focused on supportive care resources followed by monthly phone call check ins for 4 months. Participants complete questionnaires over the phone with a research coordinator at baseline, 6 months and 9 months.

.

Вмешательства

  • Поведенческое ACCESS Supportive Care
    ACCESS Supportive Care includes: 1. Coaching sessions: 6 one-hour weekly Community Navigator led supportive and early palliative care health coaching sessions. Sessions will be hybrid (in-person or virtual) per participant preference. 2. Monthly check-in: Monthly check-ins (\~5-10 minutes) about their supportive care and social determinants of health needs over 16 weeks. 3. Scheduling of outpatient supportive oncology appointment if interested. 4. Community linkage: Warm hand offs and connectio
  • Поведенческое Phone sessions
    6 weekly phone sessions, approximately 10 minutes in length each, to review breast cancer and supportive and palliative care resources in NYC and online. The 6 weekly phone sessions will include the topics discussed in the intervention arm but will be informational in nature. The phone sessions will be followed by monthly check-ins (\~5 minutes) to review and answer questions about the resources for the duration of 16 weeks.

Первичные конечные точки

  • Number of participants recruited [Срок оценки: at 9 months]
  • Number of participants remaining in study [Срок оценки: at 9 months]
  • Number of times navigator communicates with oncology team [Срок оценки: 9 months]
  • Number of times participants connect to resources [Срок оценки: 9 months]
  • Number of visits [Срок оценки: 6 months]
  • Number of phone calls [Срок оценки: 9 months]
  • Number of visits conducted according to the ACCESS manual [Срок оценки: 9 months]
  • Change in The Impact of Event Scale - Revised (IES-R) scores [Срок оценки: Baseline and 9 months]
  • Change in The Memorial Symptom Assessment Scale (MSAS) [Срок оценки: Baseline and 9 months]

Критерии участия

Критерии включения

  • Women ≥18 years of age
  • English and/or Spanish speaking
  • Self-identify as Latina and/or African American/Black
  • Ability to understand and the willingness to sign a written informed consent
  • Stage IV breast cancer diagnosis, no time component

Критерии исключения

  • Moderate to severe cognitive impairment
  • receiving inpatient hospice care
  • if patients were previously enrolled in Aim 1 and Aim 2
  • currently working with a community navigator

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 · 1 центр
  • Mount Sinai Hospital — New York

Идентификаторы

NCT: NCT06405828 · Study-21-01250 · K08CA267309

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗