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Идёт набор NCT06470750

Feasibility of Patient-Centered Home Care (PCHC) to Reduce Disparities in High-Risk Black Men (BM) With Prostate Cancer (CaP)

— Наблюдательное Prostate Adenocarcinoma

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: Non-Interventional Study.
Кому может быть актуально
Состояния в реестре: Prostate Adenocarcinoma. Базовые параметры: от 18 лет · Мужчины.
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

Feasibility of Patient-Centered Home Care (PCHC) to Reduce Disparities in High-Risk Black Men (BM) With Advanced Prostate Cancer (CaP)

Обзор

This study evaluates the possibility of patient-centered home care as a new model of cancer care to reduce disparities and improve health related quality of life and patient-reported outcomes in Black patients with prostate cancer.

Подробное описание

PRIMARY OBJECTIVES:

I. To evaluate a highly innovative project evaluating the feasibility of patient-centered home care PCHC as a new model of cancer care to reduce disparities and improve health related QoL (HRQoL) and patient reported-outcomes (PROs) in Black patients with advanced prostate cancer (CaP). (Phase I) II. Establish patient-centeredness by exploring patients' choice relative to the place of CaP treatment for certain aspects of therapy as well as end-of-life care.

III. Establish the acceptance and impact of PCHC on PROs and HRQoL in BM with advanced CaP.

OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.

GROUP 1: Participants take part in a focus group or complete questionnaires and may take part in an interview on study.

GROUP 2: Participants complete questionnaires throughout the study.

Вмешательства

  • Другое Non-Interventional Study
    Non-interventional study

Первичные конечные точки

  • Feasibility of Patient-centered Home Care (PCHC) [Срок оценки: Up to 6 months]
Вторичные конечные точки (2)
  • Time to emergency room visit [Срок оценки: Up to 6 months]
  • Time to hospital visit [Срок оценки: Up to 6 months]

Критерии участия

Критерии включения

  • GROUP 1 FOCUS GROUPS:
  • Individuals identifying as Black and male who are familiar with the landscape of medical care and cancer
  • GROUP 1 SURVEYS:
  • Are 18 years of age or older
  • Have histologic evidence of prostate adenocarcinoma
  • Are requiring, have required, or will require prostate cancer treatment
  • Have an understanding of the protocol and its requirements
  • Are willing to fill in a questionnaire and participate in a focused interview
  • Are able and willing to sign an informed consent
  • GROUP 1 INTERVIEWS:
  • Enrollment in the survey phase of the protocol
  • GROUP 2:
  • Are 18 years of age or older
  • Are Black men or other discounted patients (older adults, individuals residing in rural or remote areas, and those facing transportation challenges)
  • Have histologic evidence of prostate adenocarcinoma
  • Are requiring active standard hormone-based therapies (degarelix or leuprolide), antibone resorptive agents (zoledronic acid or denosumab), oral anticancer treatments (abiraterone or second-generation androgen receptor blockers) or intravenous chemotherapy (docetaxel)
  • Are receiving part of supportive care/symptom management and/or anti-cancer therapy in the home as part of Cancer Care Beyond Walls (CCBW)
  • Have an understanding of the protocol and its requirements
  • Are able and willing to sign informed consent

Критерии исключения

  • GROUP 1 FOCUS GROUPS:
  • Individuals who do not identify as Black or male or who have had no extensive interaction with the healthcare system
  • GROUP 1 SURVEYS:
  • Do not identify as Black men
  • Have not been diagnosed with prostate cancer
  • GROUP 1 INTERVIEWS:
  • Not enrolled in the survey phase of the protocol
  • GROUP 2:
  • Do not identify as Black men or other discounted patients (older adults, individuals residing in rural or remote areas, and those facing transportation challenges)
  • Have not been diagnosed with histologic evidence of prostate adenocarcinoma
  • Are not requiring active standard anti-cancer therapy

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Mayo Clinic in Florida — Jacksonville

Идентификаторы

NCT: NCT06470750 · CaP PCHC · W81XWH2210969 · W81XWH2210968 · NCI-2024-04792 · 22-004375 · CaP PCHC

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗