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Идёт набор NCT03322891

Improving Health Literacy in African-American Prostate Cancer Patients

Без фазы С лечением Prostate 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: Educational Supplement, Standard Practice Education.
Кому может быть актуально
Состояния в реестре: Prostate Cancer. Базовые параметры: 25 лет — 100 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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Обзор

Investigators propose an observational interview study to explore how patients understand treatment conversations with their physicians within the framework of health literacy. The study team will test whether patients' understanding of treatment options and side effects can be improved when patients receive a low literacy educational supplement after meeting with their urologist. Investigators will interview a group of newly diagnosed, early stage, African American prostate cancer patients.

Подробное описание

Investigators propose an observational interview study to explore how patients understand treatment conversations with their physicians within the framework of health literacy. The study team will test whether patients' understanding of treatment options and side effects can be improved when patients receive a low literacy educational supplement after meeting with their urologist. Investigators will interview a group of newly diagnosed, early stage, African American prostate cancer patients.

Investigators hypothesize that the delivery of a scripted, tailored, low literacy educational supplement will result in a statistically significant decrease in decisional conflict, and a statistically significant improvement in comprehension of cancer treatment and its side effects compared to standard practice.

The study team will measure patients' comprehension of treatment options and side effects, as well as decisional conflict; after standard practice, and again after exposure to the educational supplement. Investigators will compare the urologists' assessment of patients' 1) health literacy 2) preferences for side effects 3) stage of decision making, 4) treatment choice or predisposition toward treatment choice. 5) preference for role in decision making (active, passive, or shared with physician); to measures obtained from patients. These comparisons will allow investigators to quantify the potential benefit to the physician of information obtained through the interview and low literacy educational supplement.

Вмешательства

  • Другое Educational Supplement
    Participants will receive education about prostate cancer and treatments using models and props during a face-to-face interview. During the interview, participants will also be asked about medical terms and treatments regarding prostate cancer. The interview will last 45 to 60 minutes.
  • Другое Standard Practice Education
    Participants will receive traditional standard of care education regarding prostate cancer treatments and side effects provided by their physician.

Первичные конечные точки

  • Change in Decisional Conflict Scale Score [Срок оценки: Baseline, Post-Intervention (Up to 6 Weeks)]
  • Change in Comprehension of Treatment Options Score assessed by Interview [Срок оценки: Baseline, Post-Intervention (Up to 6 Weeks)]
  • Change in Comprehension of Side Effects Score assessed by Interview [Срок оценки: Baseline, Post-Intervention (Up to 6 Weeks)]
Вторичные конечные точки (2)
  • Rapid Estimate of Adult Literacy in Medicine (REALM) Score [Срок оценки: Baseline]
  • Change in the Stage of Decision Making Scale Score [Срок оценки: Baseline, Post-Intervention (Up to 6 Weeks)]

Критерии участия

Критерии включения

  • Patients who have undergone pathology review of their prostate biopsy at Emory University, Grady Memorial Hospital, Saint Joseph's Hospital, and Atlanta VA Medical Center with AJCC clinical stage T1-T2 prostate cancer by physical exam

Критерии исключения

  • RN or MD degree
  • History of head injury or dementia
  • History of cognitive impairment
  • Unable to undergo the informed consent process and the study interview in English per the judgment of the primary urologist or urological provider

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

США · 4 центра
  • Atlanta VA Medical Center — Atlanta
  • Grady Memorial Hospital — Atlanta
  • Emory University — Atlanta
  • Emory Saint Joseph's Hospital — Atlanta

Идентификаторы

NCT: NCT03322891 · IRB00091879

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗