Меню
Набор скоро начнётся NCT07126548

A Point of Prostate Cancer Diagnosis Virtual Reality Assistant Intervention in Supporting Newly Diagnosed Black Men

Без фазы С лечением Prostate Carcinoma

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: Best Practice, Discussion, Survey Administration, Virtual Reality.
Кому может быть актуально
Состояния в реестре: Prostate Carcinoma. Базовые параметры: Без ограничений · 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Pragmatic Clinical Trial to Evaluate the Effect of a Point of Prostate Cancer Diagnosis (PPCD) Virtual Reality Assistant (ViRA) in Supporting Newly Diagnosed Black Men

Обзор

This clinical trial tests how well a point of prostate cancer diagnosis (PPCD) virtual reality assistant (ViRA) intervention works in supporting Black men with newly diagnosed prostate cancer. Cancer is the second leading cause of death for African American/Black men, with prostate cancer leading in estimated new cancer cases and second in estimated new cancer deaths. Over 40,000 African American/Black men are diagnosed with prostate cancer annually, with 1 in 6 lifetime probability of developing prostate cancer compared to 1 in 8 probability in White men. The PPCD ViRA provides psycho-oncology support, social determinants of health navigation and emotional support for ethnically diverse African American/Black men newly diagnosed with prostate cancer using artificial intelligence and augmented reality. Using PPCD ViRA may close the prostate cancer care gap for African American/Black men across the cancer continuum and provide emotional, educational, and resource needs of this population when they are visiting a doctor about their prostate health or prostate cancer.

Подробное описание

PRIMARY OBJECTIVES:

I. Evaluate the effectiveness of the PPCD ViRA (i) on the delivery of PPCD support in a clinic setting, at home and community setting; and (ii) in providing social determinants of health (SDOH) navigation, emotional support and psycho-oncology support for African American/Black men (AA/BM) newly diagnosed with prostate cancer (CaP).

II. Assess the effectiveness of the PPCD ViRA in reducing emotional distress and improving other patient reported outcomes (PROs).

III. Using a mixed-method approach, explore the factors that uniquely influence the implementation of the PPCD ViRA in a clinic setting, at home and community setting.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (DELAYED-START INTERVENTION): Patients receive standard care and then receive access to the ViRA application (app) (on a \[virtual reality\] VR headset, smartphone, iPAD or computer) and are presented with short screening questions, which an AI engine uses to recommend personalized and culturally tailored VR ready CaP interventions facilitated by a digital human character (CaP survivor, physician, or a psycho-oncologist) 3 months later on study.

ARM II (EARLY START INTERVENTION): Patients receive access to the ViRA app (on a VR headset, smartphone, iPAD or computer) and are presented with short screening questions, which an AI engine uses to recommend personalized and culturally tailored VR ready CaP interventions facilitated by a digital human character (CaP survivor, physician, or a psycho-oncologist) on study.

After completion of study intervention, patients are followed up at 1, 3, 6, 9 and 12 months.

Вмешательства

  • Другое Best Practice
    Receive standard care
  • Другое Discussion
    Ancillary studies
  • Другое Survey Administration
    Ancillary studies
  • Процедура Virtual Reality
    Receive access to ViRA application

Первичные конечные точки

  • Reach - enrollment [Срок оценки: Baseline]
  • Reach - acceptance of ViRA [Срок оценки: Baseline]
  • Reach - initiation of ViRA [Срок оценки: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months]
  • Utilization of the PPCD ViRA [Срок оценки: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months]
Вторичные конечные точки (3)
  • Change in social determinants of health (SDOH) navigation [Срок оценки: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months]
  • Change in emotional support [Срок оценки: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months]
  • Psycho-oncology support [Срок оценки: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months]

Критерии участия

Критерии включения

  • African American/Black male
  • Diagnosed with CaP within two months
  • Be a patient at a participating clinic or affiliates with one of our community sites
  • Consent to participating in the study

Критерии исключения

  • Do not speak or understand English
  • Unable to read or write

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
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • Mayo Clinic in Florida — Jacksonville

Идентификаторы

NCT: NCT07126548 · MC250501 · HT94252411104 · PC230672P11 · 24-013879

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗