Clinical trial NCT06860425: Use of a Comprehensive, Mobile Application to Assist Cancer Patients With Diet, Nutrition and Activity
Official title: Use of a Comprehensive, Mobile Application to Assist Cancer Patients With Diet, Nutrition and Activity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mobile Applications
Cancer Patients
Keywords: Diet
Nutrition
Activity
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Patient Satisfaction
timeFrame: Upon completion of treatment regimen or up to 12 months after study entry
Secondary outcomes:
measure: Frequency of Engagement - Patients
timeFrame: Up to approximately 12 months after study entry
measure: Frequency of Engagement - Providers
timeFrame: Up to approximately 12 months after study entry
measure: Frequency of Engagement - Patients
timeFrame: Up to approximately 12 months after study entry
measure: Frequency of Engagement - Providers
timeFrame: Up to approximately 12 months after study entry
measure: Average Interaction Time - Patients
timeFrame: Up to approximately 12 months after study entry
measure: Drop-out over time.
timeFrame: Up to approximately 12 months after study entry
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Einstein Comprehensive Cancer Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Rafi Kabarriti, MD
role: PRINCIPAL_INVESTIGATOR
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