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

February 20, 2026 updated by: Montefiore Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Einstein Comprehensive Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Active Treatment
25 patients who prior to initiation of curative treatment.
Other: RestoreMe
Comprehensive mobile device application
Other: Follow-up/Survivorship Care
25 patients who are in post-radiation therapy follow-up/survivorship care after completing definitive treatment.
Other: RestoreMe
Comprehensive mobile device application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: Upon completion of treatment regimen or up to 12 months (+/1 month) after study entry
Patient satisfaction with the RestoreMe app will be measured using the Technology Acceptability Survey (TAS). The TAS consists of 10 questions including 7 quantitative items which will be used to assess Patient Satisfaction for the purposes of the study. Each of the 7 quantitative items on the survey represent a unique satisfaction parameter and are scored on a 5-point ordinal scale ranging from 1-5. Lower scores for an item correlate with increased satisfaction with the specific parameter and higher scores for an item correlate with decreased satisfaction for the specific parameter, yielding an overall possible scoring range of 7-35. Group scores will be summarized using basic descriptive statistics.
Upon completion of treatment regimen or up to 12 months (+/1 month) after study entry

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Dailly Engagement - Patients
Time Frame: Up to approximately 12 months (+/1 month) after study entry
Frequency of patient engagement will be assessed by the number/percentage of patients who interact with the RestoreMe app on a daily basis (i.e., number/percentage per day) as well as the number/percentage of days with at least one RestoreMe app engagement on a per patient basis (i.e., number/percentage of days with at least one patient engagement). Results will be summarized and reported by study arm/group using basic descriptive statistics.
Up to approximately 12 months (+/1 month) after study entry
Frequency of Weekly Engagement - Patients
Time Frame: Up to approximately 12 months (+/1 month) after study entry
Frequency of patient engagement will be assessed by the number/percentage of patients who interact with the RestoreMe app on a weekly basis (i.e., number/percentage per week) as well as the number/percentage of weeks with at least one RestoreMe app engagement on a per patient basis (i.e., number/percentage of weeks with at least one patient engagement). Results will be summarized and reported by study arm/group using basic descriptive statistics.
Up to approximately 12 months (+/1 month) after study entry
Frequency of Monthly Engagement - Patients
Time Frame: Up to approximately 12 months (+/1 month) after study entry
Frequency of patient engagement will be assessed by the number/percentage of patients who interact with the RestoreMe app on a monthly basis (i.e., number/percentage per month) as well as the number/percentage of months with at least one RestoreMe app engagement on a per patient basis (i.e., number/percentage of months with at least one patient engagement). Results will be summarized and reported by study arm/group using basic descriptive statistics.
Up to approximately 12 months (+/1 month) after study entry
Frequency of Daily Engagement - Providers
Time Frame: Up to approximately 12 months (+/1 month) after study entry
Frequency of provider engagement will be assessed by the number/percentage of providers who interact with the RestoreMe app on a daily basis (i.e., number/percentage per day) as well as the number/percentage of days with at least one RestoreMe app engagement on a per provider basis (i.e., number/percentage of days with at least one provider engagement). Results will be summarized and reported by study arm/group using basic descriptive statistics.
Up to approximately 12 months (+/1 month) after study entry
Frequency of Weekly Engagement - Providers
Time Frame: Up to approximately 12 months (+/1 month) after study entry
Frequency of provider engagement will be assessed by the number/percentage of providers who interact with the RestoreMe app on a weekly basis (i.e., number/percentage per week) as well as the number/percentage of weeks with at least one RestoreMe app engagement on a per provider basis (i.e., number/percentage of weeks with at least one provider engagement). Results will be summarized and reported by study arm/group using basic descriptive statistics.
Up to approximately 12 months (+/1 month) after study entry
Frequency of Monthly Engagement - Providers
Time Frame: Up to approximately 12 months (+/1 month) after study entry
Frequency of provider engagement will be assessed by the number/percentage of providers who interact with the RestoreMe app on a monthly basis (i.e., number/percentage per month) as well as the number/percentage of months with at least one RestoreMe app engagement on a per provider basis (i.e., number/percentage of months with at least one provider engagement). Results will be summarized and reported by study arm/group using basic descriptive statistics.
Up to approximately 12 months (+/1 month) after study entry
Average Daily Interaction Time - Patients
Time Frame: Up to approximately 12 months (+/1 month) after study entry
Average patient interaction time with the RestoreMe app will be measured on a daily basis to evaluate interaction over time. Group mean daily interaction time will be summarized and reported by study arm/group.
Up to approximately 12 months (+/1 month) after study entry
Average Weekly Interaction Time - Patients
Time Frame: Up to approximately 12 months (+/1 month) after study entry
Average patient interaction time with the RestoreMe app will be measured on a weekly basis to evaluate interaction over time. Group mean weekly interaction time will be summarized and reported by study arm/group.
Up to approximately 12 months (+/1 month) after study entry
Average Monthly Interaction Time - Patients
Time Frame: Up to approximately 12 months (+/1 month) after study entry
Average patient interaction time with the RestoreMe app will be measured on a monthly basis to evaluate interaction over time. Group mean monthly interaction time will be summarized and reported by study group.
Up to approximately 12 months (+/1 month) after study entry
Drop-out over time.
Time Frame: Up to approximately 12 months (+/1 month) after study entry
The proportion/percentage of patients who drop out of regular interaction with the RestoreMe app will be summarized and reported.
Up to approximately 12 months (+/1 month) after study entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Rafi Kabarriti, MD, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 6, 2025

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-13979

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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