Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York, 10461, United States
Location status: Recruiting
NCT Number: NCT06860425
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
The Bronx, New York, 10461, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Comprehensive mobile device application
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Rafi Kabarriti, MD
CONTACT
Rikin Gandhi
CONTACT
Montefiore Medical Center
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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