Use of a Comprehensive, Mobile Application to Assist Cancer Patients With Diet, Nutrition and Activity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontefiore Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
RestoreMe
Other interventionComprehensive mobile device application
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Active TreatmentOther 1 intervention
Group B: Follow-up/Survivorship CareOther 1 intervention
Trial outcomes
Primary outcomes
1
Patient Satisfaction
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
Upon completion of treatment regimen or up to 12 months (+/1 month) after study entrySecondary outcomes
1
Frequency of Dailly Engagement - Patients
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 entry2
Frequency of Weekly Engagement - Patients
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 entry3
Frequency of Monthly Engagement - Patients
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 entry4
Frequency of Daily Engagement - Providers
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 entrySponsors and contacts
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Source ClinicalTrials.gov