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Идёт набор NCT07696637

Access My Breast Cancer Care App

Без фазы С лечением Breast Reconstruction 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: Access My Breast Cancer Care App, Standard Pathway.
Кому может быть актуально
Состояния в реестре: Breast Reconstruction, Breast Cancer. Базовые параметры: от 19 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
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Access my Breast Cancer Care - Use of an eHealth App in Navigating the Breast Cancer Trajectory: A Randomized Controlled Trial

Обзор

The Access my Breast Cancer Care application was developed by a multidisciplinary team with the intention of providing breast cancer patients with a centralized area to navigate their journey. Several of the research team members (Dr. Macadam, Dr. Isaac, Selena (CNS) and Pauline (CNS)) provided clinical expertise to ensure accuracy of clinical content. The application houses educational resources, a calendar, symptom tracker, customizable care pathway, community forum and a chat feature. The study will be designed as a randomized controlled trial (RCT) to measure the effect of the application on patient-centered outcomes of 1) satisfaction with care 2) reduction in adverse events, 3) usability. The investigators will conduct focus groups to understand the benefit of the app from the patient perspective.

Подробное описание

Background: This App has been developed by stakeholders engaged in breast cancer reconstruction, including patients, physicians, allied health workers, hospital administration, and hospital leadership. Its development and evaluation follow the Cancer Care Research framework to ensure its utility and integration are optimized for impact in cancer care

Purpose: To evaluate whether a centralized breast cancer care app can improve patient navigation, empowerment, and decision-making, while also reducing the number of in person clinic visits, and time from symptom onset to specialist review. The investigators will also evaluate app usability and usage.

Hypothesis: Providing patients with access to the "Access my Breast Cancer Care" app will improve patient care satisfaction and patient outcomes compared to usual standard care, resulting in fewer in person clinic visits, high satisfaction of care, earlier detection of complications, and greater patient confidence in managing their care.

Justification: Breast cancer patients often face fragmented care and difficulty accessing timely resources. A centralized app may provide consistent support, improve communication, and enhance efficiency in care delivery. Evaluating its impact is necessary to determine the benefits to patients and potential cost savings for the healthcare system.

Objectives: 1) To evaluate, from the patient perspective, the impact of a centralized breast cancer app on navigation of the breast cancer journey when undergoing reconstruction; 2) To evaluate the impact of a centralized breast cancer app on the delivery of care, including number of in-person specialist visits and time from symptom onset to specialist review; 3) To evaluate the app usability and usage during the breast cancer journey.

Research design: A mixed methods approach will be utilized. A randomized control trial with both quantitative and qualitative data will be collected and analyzed. Quantitative outcomes include BREAST-Q scores, MARS scores, SUS scores, and delivery of care quality indicators.

Statistical analysis: Qualitative analysis will be completed using constant comparison and retrieval of themes. Primary analysis of patient care satisfaction using the BREAST-Q will be conducted using ANCOVA. For secondary outcomes, the investigators will apply negative binomial regression for number of in person visits, survival analysis using Kaplan-Meier curves, and log-rank test for time to specialist review, gamma regression with log link to assess information seeking time, and wilcoxon sum for app usability using the MARS and/or SUS scale. The investigators will use measures of central tendency to evaluate app usage (# of logins and # of education resources accessed).

Вмешательства

  • Другое Access My Breast Cancer Care App
    App designed by our VCH team for patients with breast cancer to navigate their care pathways
  • Другое Standard Pathway
    These patients will undergo standard breast cancer care without access to the app

Первичные конечные точки

  • Does access to a centralized breast cancer app improve patient navigation during breast cancer reconstruction journey [Срок оценки: 1 month and 6 months]
Вторичные конечные точки (2)
  • Does the app improve reduce the amount of emergency room visits? [Срок оценки: 1 month and 6 months]
  • Does the app reduce wait times to specialist review? [Срок оценки: 1 month and 6 month]

Критерии участия

Критерии включения

  • You are at least 19 years of age (the team only treats adult patients)
  • You have a diagnosis of breast cancer, or a BRCA mutation, and will be -having breast surgery with reconstruction (the app is tailored the breast cancer journey)
  • You have access to a smartphone or computer (individuals participating in the study will require access to a smart phone or computer to access the application if randomized to the intervention group)
  • Must have basic reading skills in English (the app is only available in English language)

Критерии исключения

  • You do not have access to a smartphone or computer (a computer or smart phone is required to access the application)
  • You are <19 years of age (the team does not treat pediatric patients)
  • You do not have breast cancer or a BRCA mutation (the application is specific to the breast cancer journey)
  • You decline breast reconstruction (the application was designed by the plastics and reconstructive team, and with the app being in an infancy stage, the bulk of the content focuses on breast reconstruction surgery)
  • You are not able to read English (the app is only available in English language)

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
Открытое
Основная цель
Организация здравоохранения

Центры проведения

Канада · 2 центра
  • Providence Health Care — Vancouver
  • Vancouver Coastal Health — Vancouver

Идентификаторы

NCT: NCT07696637 · H25-03017

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗