Mobile APP Utilization for Enhanced Post-Operative Nutritional Recovery

This study is to assess the usability and acceptability of a digital food consumption diary as part of the perioperative management of gastrointestinal oncology patients and to evaluate the impact of a digital food diary on adherence to dietician-recommended plan and on quality recovery, using a commercially available smart phone application.

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Key information

Conditions

GI Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Malnutrition Neoplasms Neoplasms by Site Nutrition Disorders Nutritional Deficiency Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

H Lee Moffitt Cancer & Research Institute

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of gastrointestinal (GI) cancers confirmed by tissue diagnosis and/or clinical presentation as judged by the treating physician
Candidate for curative-intent surgery
Participants will be eligible for participation regardless of degree of malnutrition (as determined at pre-operative dietary consultation)
Own a smartphone with iOS or Android operating systems with WiFi or 3G/4G connection
Willingness to download the Livestrong.com MyPlate Calorie Tracker onto a personal smart phone with assumption and responsibility for individual data usage, and creation of login for website data extraction
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study.
Sufficient English language proficiency to execute study tasks

Exclusion criteria

Participants with tube feeds and/or need for parenteral/enteral nutrition
Participants not willing to download or utilize the commercially available weight monitoring application

Treatment and study plan

My Plate Calorie Tracker

Other

My Plate Calorie Tracker is a user-friendly weight management, calorie record application, available for smart phone devices. Users have the option to input items manually (i.e., calories, carbohydrates, fats, and proteins), select from a list of popular food items, or scan barcodes on the food packaging. In addition to food entries, users can also enter daily water intake and physical activities. Once an account is created, data entered into the mobile application can be sync'd to the "My Plate Calorie Tracker" website.

Other names: mobile application

Primary outcomes

Usability of Smart Phone Application

Time frame: Up to 3 months

Usability of smart phone application will be captured by (1) number of days that entries have been made by the study participants and recorded as a percentage of the total number of days after discharge from the hospital (obtained from mobile application (2) number of meals recorded in the application per day (obtained from mobile application) and (3) Exit Questionnaire (6 questions of 12). The Exit Questionnaire includes a mixture of 5-point Likert-scale, yes or no, and open-ended items to assess usability. Questions on the 5 point scale use 1 as an indication of difficulty in using application and 5 would be ease of use.
Acceptability of Smart Phone Application

Time frame: Up to 3 months

Patient's acceptability of the mobile application to assist with postoperative nutrition goals will be captured by the Exit Questionnaire (6 questions of 12). The Exit Questionnaire includes a mixture of 5-point Likert-scale, yes or no, and open-ended items to assess acceptability. Questions on the 5 point scale use 1 as an indication of acceptability issues of the application and 5 would be acceptability.

Secondary outcomes

Adherence to Recommended Nutritional Plan

Time frame: Up to 3 months

Adherence to the participant's recommended nutritional plan will be calculated by participant's energy (caloric) intake over time, as recorded in the digital food diary, and compared to estimates of the optimum energy needs established by the dietician. Adherence will be reported as a percentage of estimated energy requirements.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2022
First posted: Sep 16, 2019
Registry last updated: Apr 11, 2023

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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Completed