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Идёт набор NCT06860425

Use of a Comprehensive, Mobile Application to Assist Cancer Patients With Diet, Nutrition and Activity

Без фазы С лечением Mobile Applications Cancer Patients

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: RestoreMe.
Кому может быть актуально
Состояния в реестре: Mobile Applications, Cancer Patients. Базовые параметры: от 18 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The overarching purpose of this study is to assess whether patients will use the app throughout treatment on a regular basis, as the ultimate goal is to provide an educational platform that can impact patient behaviors and understanding towards health.

Подробное описание

In the last decade, smartphones have become an essential part of society with the mobile application market offering services across all aspects of life, including healthcare. Mobile health care apps have developed a field of their own termed "mobile health" or m-health with apps available to help patients do everything from managing symptoms and tracking medications to improving treatment compliance.

Apps have been developed specifically tailored for oncology patients. One randomized controlled trial provided oncology patients receiving palliative care with a mobile application that used artificial intelligence (AI) to regularly monitor and manage pain between clinic visits. Results showed that the app was an effective tool to manage pain. Patients who used the app reported an overall decrease in pain severity and experienced fewer inpatient hospitalizations due to cancer-related pain compared with patients who did not use the app. M-health applications are well utilized in low-income populations and among both English and Spanish speakers.

Despite the exciting potential m-Health offers for providers and patients, it also presents challenges. One systematic review identified barriers to adoption of m-health apps by health care professionals including difficult user experience (i.e., users found the app difficult to use and navigate), design and technical issues, security concerns, and perceived usefulness. Therefore, when designing an m-Health app, care must be taken to ensure that it is functional, easy to use, and provides patients and providers with valuable information in order to ensure that users will engage with the app. M-health apps should also be designed to supplement information exchanged during clinical encounters, fill in gaps in clinical workflow, and be appropriate for the target patient population.

Low socioeconomic status is associated with increased disease prevalence and low quality of life after diagnosis. Bronx county, New York, which is coterminous with the New York City borough of The Bronx, is an urban, medically underserved and economically depressed area, which is associated with an elevated relative rate of chronic diseases including obesity, diabetes, hypertension and cardiovascular disease. Over 70% of patients served by the Montefiore-Einstein Cancer Center (MECC) live beneath the poverty line suggesting that the patient population served by MECC is at risk for poor nutrition status.

With the goal of improving availability of evidence-based nutritional information to MECC patients, both in the active-treatment and survivorship settings, the study team has developed "RestoreMe," an easy-to-use mobile device application that provides nutrition education, personalized recommendations, recipes, exercises and more. RestoreMe also allows cancer patients and providers an easy-to-use resource with which to communicate directly with one another, which may increase patient engagement and compliance with their overall care.

In this study, the study team will investigate the regularity of app use by patients and which functions of the app are used effectively and most often. Usage trends specific to particular patient subgroups will also be evaluated. The results of this feasibility study will inform a future prospective interventional study using the RestoreMe app.

Вмешательства

  • Другое RestoreMe
    Comprehensive mobile device application

Первичные конечные точки

  • Patient Satisfaction [Срок оценки: Upon completion of treatment regimen or up to 12 months (+/1 month) after study entry]
Вторичные конечные точки (10)
  • Frequency of Dailly Engagement - Patients [Срок оценки: Up to approximately 12 months (+/1 month) after study entry]
  • Frequency of Weekly Engagement - Patients [Срок оценки: Up to approximately 12 months (+/1 month) after study entry]
  • Frequency of Monthly Engagement - Patients [Срок оценки: Up to approximately 12 months (+/1 month) after study entry]
  • Frequency of Daily Engagement - Providers [Срок оценки: Up to approximately 12 months (+/1 month) after study entry]
  • Frequency of Weekly Engagement - Providers [Срок оценки: Up to approximately 12 months (+/1 month) after study entry]
  • Frequency of Monthly Engagement - Providers [Срок оценки: Up to approximately 12 months (+/1 month) after study entry]
  • Average Daily Interaction Time - Patients [Срок оценки: Up to approximately 12 months (+/1 month) after study entry]
  • Average Weekly Interaction Time - Patients [Срок оценки: Up to approximately 12 months (+/1 month) after study entry]
  • Average Monthly Interaction Time - Patients [Срок оценки: Up to approximately 12 months (+/1 month) after study entry]
  • Drop-out over time. [Срок оценки: Up to approximately 12 months (+/1 month) after study entry]

Критерии участия

Критерии включения

  • Diagnosis of invasive malignancy of the brain, head and neck region, lung, breast (DCIS and invasive disease allowed), prostate, gastrointestinal system or gynecological region
  • Planned to receive, or have received, radiation therapy treatment with curative intent
  • Note: Patients undergoing systemic therapy are eligible
  • Note: Any dose/fractionation of curative-intent radiation therapy is eligible
  • Patients must have a smartphone or other device with the ability to receive text messages, download and use mobile applications
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Ability to read and write in English
  • Provide written informed consent to participate in the study o NOTE: Patients enrolled on another clinical trial are eligible

Критерии исключения

  • Metastatic cancer
  • Undergoing treatment with palliative intent
  • Poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL despite attempts to improve glucose control by fasting duration and adjustment of medications)
  • Uncontrolled hypertension
  • Any medical condition requiring fluid restriction or nutrient restrictions

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • Montefiore Einstein Comprehensive Cancer Center — The Bronx

Публикации

  • Gagnon MP, Ngangue P, Payne-Gagnon J, Desmartis M. m-Health adoption by healthcare professionals: a systematic review. J Am Med Inform Assoc. 2016 Jan;23(1):212-20. doi: 10.1093/jamia/ocv052. Epub 2015 Jun 15. PMID 26078410
  • Kamdar, Mihir M., et al.
  • Liu, Patrick, et al.
  • Mielck A, Vogelmann M, Leidl R. Health-related quality of life and socioeconomic status: inequalities among adults with a chronic disease. Health Qual Life Outcomes. 2014 Apr 25;12:58. doi: 10.1186/1477-7525-12-58. PMID 24761773
  • NYS DOH. 2013-2014 NYS Expanded Behavioral Risk Factor Surveillance System, data as of 2015. Available: https://www.health.ny.gov/statistics/chac/general/g75.htm. Accessed 23 September 2016.
  • Pierce JP, Faerber S, Wright FA, Rock CL, Newman V, Flatt SW, Kealey S, Jones VE, Caan BJ, Gold EB, Haan M, Hollenbach KA, Jones L, Marshall JR, Ritenbaugh C, Stefanick ML, Thomson C, Wasserman L, Natarajan L, Thomas RG, Gilpin EA; Women's Healthy Eating and Living (WHEL) study group. A randomized trial of the effect of a plant-based dietary pattern on additional breast cancer events and survival: PMID 12505249
  • Chan DSM, Vieira AR, Aune D, Bandera EV, Greenwood DC, McTiernan A, Navarro Rosenblatt D, Thune I, Vieira R, Norat T. Body mass index and survival in women with breast cancer-systematic literature review and meta-analysis of 82 follow-up studies. Ann Oncol. 2014 Oct;25(10):1901-1914. doi: 10.1093/annonc/mdu042. Epub 2014 Apr 27. PMID 24769692
  • Protani M, Coory M, Martin JH. Effect of obesity on survival of women with breast cancer: systematic review and meta-analysis. Breast Cancer Res Treat. 2010 Oct;123(3):627-35. doi: 10.1007/s10549-010-0990-0. Epub 2010 Jun 23. PMID 20571870

Идентификаторы

NCT: NCT06860425 · 2022-13979

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗