Use of a Comprehensive, Mobile Application to Assist Cancer Patients With Diet, Nutrition and Activity
NCT ID: NCT06860425
Last Updated: 2025-03-06
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
50 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-02-28
Study Completion Date
2026-01-31
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Mobile Applications
Cancer Patients
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
SEQUENTIAL
Primary Study Purpose
HEALTH_SERVICES_RESEARCH
Blinding Strategy
NONE
Study Groups
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Active Treatment
25 patients who prior to initiation of curative treatment.
Group Type
OTHER
RestoreMe
Intervention Type
OTHER
Comprehensive mobile device application
Follow-up/Survivorship Care
25 patients who are in post-radiation therapy follow-up/survivorship care after completing definitive treatment.
Group Type
OTHER
RestoreMe
Intervention Type
OTHER
Comprehensive mobile device application
Interventions
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RestoreMe
Comprehensive mobile device application
Intervention Type
OTHER
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Montefiore Medical Center
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Rafi Kabarriti, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
Locations
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Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York, United States
Site Status
Countries
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United States
References
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Asaro, A. M., Garg, M. K., Haynes, H., & Kabarriti, R. (2018). Customized Text Messaging to Assist Cancer Patients with Diet, Nutrition and Activity: a Pilot Study. International Journal of Radiation Oncology• Biology• Physics, 102(3), e412.
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Other Identifiers
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2022-13979
Identifier Type: -
Identifier Source: org_study_id
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