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临床试验/NCT07575685
NCT07575685尚未招募不适用

Enhancing Cancer Care: RestoreMe Application for Personalized Nutrition and Activity in Cancer Patients

Montefiore Medical Center0 个研究点目标入组 150 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
150

研究概览

简要总结

This is a single institution feasibility study of the updated RestoreMe app. The investigators plan to recruit 150 participants to this study with participants being recruited either prior to the initiation of their curative treatment or during and after completion of their cancer therapy. This design will allow the investigators to assess the feasibility of using the RestoreMe app in both the active treatment setting and follow up/survivorship setting. Information gathered from this feasibility study will inform future trial design for prospective intervention using the RestoreMe app.

详细描述

Building on user experience data from the first version of the application, the investigators have enhanced the "RestoreMe" appl to offer an even more refined experience. The updated version incorporates valuable feedback, resulting in improved functionality, more personalized features, and a more intuitive design. It also allows for connectivity to Bluetooth devices and Apple health integration to obtain weight, blood pressure, heart rate, temperature, and step counts. It features customized questionnaires [Patient Reported Outcomes (PROs)] and relevant patient information including Body Mass Index, cancer diagnosis/treatment, and preferences/restrictions to evaluate nutritional status and provide personalized and curated recommendations regarding nutrition (calorie requirements, superfoods, weekly meal plans, shopping lists, supplements), hydration, physical activity and disease education/navigation.

The investigators believe that collection of patient-generated health data, which includes physical activity metrics, physiologic data (e.g., heart rate), and PROs and their integration with symptom reporting and nutritional assessments will significantly enhance the RestoreMe® app enabling it to provide tailored diet, hydration and activity recommendations, robust personalized learning section (disease specific and curated), provide remote symptom and activity monitoring, and promote self-management (through goals and progress). The implementation of RestoreMe® in diverse populations, such as those in the Bronx, has the potential to significantly improve cancer care outcomes. These populations often face additional barriers, including language and cultural differences, that further complicate nutritional management. Multi-language translation, food preferences/restrictions, caregiver engagement and easy-to-use features are built in RestoreMe® to address these barriers.

The investigators expect that most study participants will be enrolled during their visits. At the time of study enrollment, subjects will be provided with access to the RestoreMe app and the devices listed below. Participants will receive a written guide as well as training on device use. Of note, these devices will be provided with no cost to study participants. These devices (with the exception of Garmin Vivofits, which participants can keep and use as long as they wish) will be returned at the time of study completion, either during an in-person clinic visit or using pre-packaged shipping materials.

  • Garmin Vivofits
  • iHealth Fit Nexus HS2S Weighing scale
  • iHealth Track KN550BT blood pressure monitor

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18
  • Planned to receive, or have received, cancer treatments including radiation therapy, chemotherapy, immunotherapy, or surgery
  • Must have a smartphone or other device with the ability to receive text messages, download and use mobile applications.
  • Ability to read and write English
  • Provide written informed consent to participate in the study.
  • Concurrent enrollment on other trials is permitted.

排除标准

  • Poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL despite attempts to improve glucose control by fasting duration and adjustment of medications).
  • Any medical condition requiring fluid restriction or nutrient restrictions.

研究组 & 干预措施

Intervention

Experimental

RestoreMe mobile phone application for cancer patients undergoing active cancer therapy or in follow-up/survivorship care

干预措施: RestoreMe (Other)

研究者

申办方类型
Other
责任方
Sponsor

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