Enhancing Cancer Care: RestoreMe App for Personalized Nutrition and Activity in Cancer Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontefiore Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
RestoreMe
Other interventionRestoreMe mobile device application
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
User satisfaction of RestoreMe application
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.
Time frame
Every 4 weeks after enrollment until 12 months after study entrySecondary outcomes
1
Feasibility of patient-generated health data collection using Garmin Vivofits- Step Counts
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.
Time frame
First 6 weeks from 7th day after enrollment2
Feasibility of patient-generated health data collection using Garmin Vivofits- Sedentary and Active Time
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.
Time frame
First 6 weeks from 7th day after enrollment3
Feasibility of patient-generated health data collection using Garmin Vivofits- Heart Rate
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.
Time frame
First 6 weeks from 7th day after enrollment4
Feasibility of patient-generated health data collection using iHealth Fit Nexus HS2S Weighing scale
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.
Time frame
First 6 weeks from 7th day after enrollmentLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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