Cancer, Dietary Recommendations, Mobile Applications, Nutrition Aspect of Cancer
Conditions
Keywords
Patient Reported Outcomes, Biomarker, Activity
Brief summary
This is a single institution feasibility study of the updated RestoreMe app. The investigators plan to recruit 150 participants to this study with participants being recruited either prior to the initiation of their curative treatment or during and after completion of their cancer therapy. This design will allow the investigators to assess the feasibility of using the RestoreMe app in both the active treatment setting and follow up/survivorship setting. Information gathered from this feasibility study will inform future trial design for prospective intervention using the RestoreMe app.
Detailed description
Building on user experience data from the first version of the application, the investigators have enhanced the "RestoreMe" appl to offer an even more refined experience. The updated version incorporates valuable feedback, resulting in improved functionality, more personalized features, and a more intuitive design. It also allows for connectivity to Bluetooth devices and Apple health integration to obtain weight, blood pressure, heart rate, temperature, and step counts. It features customized questionnaires \[Patient Reported Outcomes (PROs)\] and relevant patient information including Body Mass Index, cancer diagnosis/treatment, and preferences/restrictions to evaluate nutritional status and provide personalized and curated recommendations regarding nutrition (calorie requirements, superfoods, weekly meal plans, shopping lists, supplements), hydration, physical activity and disease education/navigation. The investigators believe that collection of patient-generated health data, which includes physical activity metrics, physiologic data (e.g., heart rate), and PROs and their integration with symptom reporting and nutritional assessments will significantly enhance the RestoreMe® app enabling it to provide tailored diet, hydration and activity recommendations, robust personalized learning section (disease specific and curated), provide remote symptom and activity monitoring, and promote self-management (through goals and progress). The implementation of RestoreMe® in diverse populations, such as those in the Bronx, has the potential to significantly improve cancer care outcomes. These populations often face additional barriers, including language and cultural differences, that further complicate nutritional management. Multi-language translation, food preferences/restrictions, caregiver engagement and easy-to-use features are built in RestoreMe® to address these barriers. The investigators expect that most study participants will be enrolled during their visits. At the time of study enrollment, subjects will be provided with access to the RestoreMe app and the devices listed below. Participants will receive a written guide as well as training on device use. Of note, these devices will be provided with no cost to study participants. These devices (with the exception of Garmin Vivofits, which participants can keep and use as long as they wish) will be returned at the time of study completion, either during an in-person clinic visit or using pre-packaged shipping materials. * Garmin Vivofits * iHealth Fit Nexus HS2S Weighing scale * iHealth Track KN550BT blood pressure monitor
Interventions
OTHERRestoreMe
RestoreMe mobile device application
Sponsors
Montefiore Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
All participants will receive the same intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 * Planned to receive, or have received, cancer treatments including radiation therapy, chemotherapy, immunotherapy, or surgery * Must have a smartphone or other device with the ability to receive text messages, download and use mobile applications. * Ability to read and write English * Provide written informed consent to participate in the study. * Concurrent enrollment on other trials is permitted.
Exclusion criteria
* Poorly controlled diabetes (defined as fasting glucose level \> 200 mg/dL despite attempts to improve glucose control by fasting duration and adjustment of medications). * Any medical condition requiring fluid restriction or nutrient restrictions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| User satisfaction of RestoreMe application | Every 4 weeks after enrollment until 12 months after study entry | To evaluate user satisfaction of RestoreMe app in delivering ongoing nutritional education and personalized dietary recommendations for cancer patients undergoing active cancer therapy or in follow-up/survivorship care as measured by the Technology Acceptability Survey. The overall satisfaction score at 4 weeks will be calculated from adding the scores of 10 individual scorable items (Score range: 10-50) on the Technology Acceptability Survey. The overall score of 3 or below is considered satisfactory. To estimate the mean overall score, we will calculate 95% t-confidence interval. As secondary analyses, we will calculate the confidence intervals for different time points and for individual items. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of patient-generated health data collection using Garmin Vivofits- Step Counts | First 6 weeks from 7th day after enrollment | Participants will be asked to wear the Garmin Vivofits continuously during the study period. Data collected using the Garmin Vivofits will include step counts. The investigators will calculate the rate of collecting measurements from more than 50% of the subjects. They define the rate as measurement-specific feasibility rate. To estimate the rate, they will calculate 95% exact binomial confidence interval. |
| Feasibility of patient-generated health data collection using Garmin Vivofits- Sedentary and Active Time | First 6 weeks from 7th day after enrollment | Participants will be asked to wear the Garmin Vivofits continuously during the study period. Data collected using the Garmin Vivofits will include measures of sedentary and active time. The investigators will calculate the rate of collecting measurements from more than 50% of the subjects. They define the rate as measurement-specific feasibility rate. To estimate the rate, they will calculate 95% exact binomial confidence interval. |
| Feasibility of patient-generated health data collection using Garmin Vivofits- Heart Rate | First 6 weeks from 7th day after enrollment | Participants will be asked to wear the Garmin Vivofits continuously during the study period. Data collected using the Garmin Vivofits will include heart rate. The investigators will calculate the rate of collecting measurements from more than 50% of the subjects. They define the rate as measurement-specific feasibility rate. To estimate the rate, they will calculate 95% exact binomial confidence interval. |
| Feasibility of patient-generated health data collection using iHealth Fit Nexus HS2S Weighing scale | First 6 weeks from 7th day after enrollment | Participants will be asked to use the iHealth Fit Nexus HS2S Weighing scale once a week during the study period. The investigators will calculate the rate of collecting measurements from more than 50% of the subjects. They define the rate as measurement-specific feasibility rate. To estimate the rate, they will calculate 95% exact binomial confidence interval. |
| Feasibility of patient-generated health data collection using iHealth Track KN550BT blood pressure monitor | First 6 weeks from 7th day after enrollment | Participants will be asked to use iHealth Track KN550BT blood pressure monitor once a week during the study period. The investigators will calculate the rate of collecting measurements from more than 50% of the subjects. They define the rate as measurement-specific feasibility rate. To estimate the rate, they will calculate 95% exact binomial confidence interval. |
Contacts
CONTACTRafi Kabarriti, MD
CONTACTAkash Shah
PRINCIPAL_INVESTIGATORRafi R Kabarriti, MD
Montefiore Medical Center
Outcome results
None listed