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Набор скоро начнётся NCT07599618

Evaluation of a Patient-Centered Decision-Making Support Tool for Older Adults With Advanced Breast Cancer and Their Care Partners

Без фазы С лечением Metastatic Breast 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: Decision-making support tool.
Кому может быть актуально
Состояния в реестре: Metastatic Breast Cancer. Базовые параметры: от 65 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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Обзор

The purpose of this study is to determine the feasibility for a patient centered decision-making support tool for older adults with metastatic breast cancer and their care partners.

Подробное описание

The primary objective (Aim 1) of this study will be to evaluate feasibility of utilizing the patient-centered decision-making (PCDM) tool for older adults with metastatic breast cancer (mBC). The PCDM tool has been developed by the investigators in collaboration with Manta Cares, Inc. During the development process, we have integrated Geriatric Assessment (GA), completed fully by patients, into the PCDM tool, along with potential supportive care strategies (e.g., recommendations) that could be considered by patients and their care partners if areas of impairment are noted on the GA embedded into the PDCM tool. Feasibility of the adapted PCDM tool will be assessed both quantitatively and qualitatively, and through mixed methods (integrating quantitative and qualitative data) to provide a deeper understanding of aspects of implementation across settings.

Вмешательства

  • Другое Decision-making support tool
    Determine the feasibility for a patient centered decision-making support tool for older adults with metastatic breast cancer and their care partners.

Первичные конечные точки

  • Patient and care partner Acceptability of Intervention (AIM) [Срок оценки: Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)]
  • Intervention Appropriateness Measure (IAM) [Срок оценки: Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)]
  • Feasibility of Intervention (FIM) [Срок оценки: Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)]
Вторичные конечные точки (5)
  • Patient Activation Measure-13 (PAM-13) [Срок оценки: Time Point 1: (within 2 months of informed consent) Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)]
  • Decision Self-Efficacy Scale (DSE) [Срок оценки: Time Point 1: (within 2 months of informed consent) Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)]
  • Shared Decision-Making Questionnaire (SDM-Q-9) [Срок оценки: Time Point 1: (within 2 months of informed consent) Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)]
  • Caregiver Activation Measure (CG-PAM) [Срок оценки: Time Point 1: (within 2 months of informed consent) Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)]
  • Heath Care Climate Questionnaire (HCCQ) [Срок оценки: Time Point 1: (within 2 months of informed consent) Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)]

Критерии участия

Критерии включения

Patient Inclusion Criteria:

  • A diagnosis of metastatic breast cancer
  • Age 65 or older
  • Currently receiving systemic treatment for metastatic breast cancer or considering a plan to initiate systemic treatment for metastatic breast cancer
  • Able to speak and read English (because the Manta Cares platform is presently only offered in English only)
  • Able to provide informed consent

Care Partner Inclusion Criteria:

  • Age 18 or older
  • Able to speak and read English (because the Manta Cares platform is presently only offered in English only)
  • Able to provide informed consent
  • Verbal permission from patient to enroll their designated care partner

Критерии исключения

Patient Exclusion Criteria:

  • Early-stage breast cancer
  • Diagnosis of any other cancer besides metastatic breast cancer

Care Partner Exclusion Criteria:

1\. Verbal permission from patient to enroll care partner not received.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • University of Rochester — Rochester

Идентификаторы

NCT: NCT07599618 · UOCPC25063 · STUDY00010968

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗