Using a mHealth App to Improve Quality-of-Life Outcomes in Black Prostate Cancer Survivors

Официальное название

Development and Preliminary Evaluation of a Tailored mHealth App Designed to Improve Quality-of-Life Outcomes in Ethnically-Diverse Black Prostate Cancer Survivors (SAFE-CaPs)

Обзор

The goal of this clinical trial is to ensure that the mobile health application for Black patients with prostate cancer (either actively undergoing treatment or survivors) is usable and acceptable to patients, get feedback about how to improve the app and assess its usefulness in examining their quality of life.

Подробное описание

The purpose of this study is to test the effectiveness of a culturally appropriate and specific mobile app for ethnically diverse Black men with prostate cancer (either those actively undergoing treatment or survivors) to empower them to be active participants in their care. This app will provide 1) relevant information/education about prostate cancer-specific to Black men; 2) symptoms monitoring - allowing participants to report difficulties and prompting providers to respond to concerns; and 3) testimonials from other patients with shared experiences.

All participants will be asked to complete surveys online when they start and then again at 3, 6, 9, and 12 months. A subset of randomized participants will be provided access to this app, which they will be asked to use at home for 12 months. The app users will answer daily surveys about their symptoms and activities as well as weekly mood assessments for 3 months. At the end of the 12 months, interviews will be conducted to receive feedback regarding the app.

Вмешательства

• Поведенческое Surveys for Quality of Life
  This group will take scheduled electronic surveys (at the beginning of the study, months 3, 6, 9, and 12) to assess the overall impact of prostate cancer on quality of life (QoL).
• Поведенческое Surveys and mHealth App access
  This group will take scheduled electronic surveys (at the beginning of the study, months 3, 6, 9, and 12) to assess the overall impact of prostate cancer on quality of life (QoL). Additionally, they will have a brief "initial study visit," in-person or virtually, to review the app use. This arm of participants will use the mobile application at home for 12 months. During the first 12 weeks, the application will send daily surveys about symptoms, dietary and physical activities, weekly surveys ab

Первичные конечные точки

• Overall Quality of Life (QoL) assessment in Black men with prostate cancer [Срок оценки: 12 months]

Критерии участия

Критерии включения

\- Ethnically-diverse Black prostate cancer (CaP) survivors who are either native-born, Caribbean-born, or African-born

Критерии исключения

• Men from other races.
• Men who have never been diagnosed with CaP
• Men who have the inability to speak English

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

Поддерживающая терапия

Центры проведения

США · 3 центра

• Florida State University — Tallahassee
• Georgia College & State University — Milledgeville
• University of Oklahoma HSC — Oklahoma City

Публикации

• Kumar G, Ghasemi P, Alexander AC, Dwyer K, Neil JM, Cole P, Beckford P, Reese D, Montgomery E, Odeleye R, Harris MA, Zhao YD, Nagykaldi Z, McIntosh AG, Kaninjing E, Young ME, Dickey S, Morton DJ, Bolajoko O, Odedina FT, Planas LG, Businelle MS, Kendzor DE, Ogunsanya ME. A Culturally Tailored Mobile Health Intervention to Improve Quality of Life in Black Survivors With Prostate Cancer: Protocol for PMID 41875429

Идентификаторы

NCT: NCT06651359 · OU202403MA-MHEALTH · PC230551

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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