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

Not Applicable

Active, not recruiting

• Conditions: Mobile Applications; Cancer Patients

• Registration Number: NCT06860425
• Lead Sponsor: Montefiore Medical Center

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.

Study Timeline

• Study Start: 2023-02-28
• Status Verified: 2025-03
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Study First Posted: 2025-03-06
• Last Update Posted: 2025-03-06
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction	Upon completion of treatment regimen or up to 12 months 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.

Secondary Outcome Measures

Name	Time	Method
Frequency of Engagement - Providers	Up to approximately 12 months after study entry	Frequency of provider engagement will also be assessed by the number and proportion/percentage of weeks with at least one RestoreMe app engagement on a per provider basis. Group results will be summarized and reported by study group using basic descriptive statistics.
Average Interaction Time - Patients	Up to approximately 12 months after study entry	Average patient interaction time with the RestoreMe app will be measured on a daily, weekly, and monthly basis to evaluate interaction over time. Group mean daily, weekly, and monthly interaction time will be summarized and reported by study group.
Drop-out over time.	Up to approximately 12 months after study entry	The proportion/percentage of patients who drop out of regular interaction with the RestoreMe app will be summarized and reported.
Frequency of Engagement - Patients	Up to approximately 12 months after study entry	Frequency of patient engagement will also be assessed by the number and proportion/percentage of weeks with at least one RestoreMe app engagement on a per patient basis. Group results will be summarized and reported by study group using basic descriptive statistics.

Trial Locations

Locations (1)

Montefiore Einstein Comprehensive Cancer Center; 🇺🇸 Bronx, New York, United States