Mobile APP Utilization for Enhanced Post-Operative Nutritional Recovery

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04091165
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Anticipated Duration (Months): 47.6
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
GI Cancer; Nutritional Deficiency	Other: My Plate Calorie Tracker

Study Design

• Study Type: Observational
• Actual Enrollment: 23 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Mobile APP Utilization for Enhanced Post-Operative Nutritional Recovery
• Actual Study Start Date: Sep 23, 2019
• Actual Primary Completion Date: Jul 23, 2020
• Anticipated Study Completion Date: Sep 11, 2023

Arms and Interventions

Arm

Intervention/Treatment

Study Group Participants will be identified for inclusion by leaders of the GI Clinic after GI surgery has been scheduled. Upon consenting, participants will be instructed how to download and use the mobile phone application "My Plate Calorie Counter".

Other: My Plate Calorie Tracker; 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

Outcome Measures

Primary Outcome Measures

1. Usability of Smart Phone Application [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.

2. Acceptability of Smart Phone Application [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 Outcome Measures

1. Adherence to Recommended Nutritional Plan [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	H Lee Moffitt Cancer & Research Institute	Tampa	Florida	United States	33612

Sponsors and Collaborators

• H. Lee Moffitt Cancer Center and Research Institute

Investigators

• Principal Investigator: Pamela Hodul, MD, H. Lee Moffitt Cancer Center and Research Institute

Study Documents (Full-Text)

• Informed Consent Form - Jun 14, 2019

More Information

Additional Information:

• Moffitt Cancer Center Clinical Trials website

Publications

None provided.

• Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
• ClinicalTrials.gov Identifier: NCT04091165
• Other Study ID Numbers: MCC-19978
• First Posted: Sep 16, 2019
• Last Update Posted: Jun 2, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by H. Lee Moffitt Cancer Center and Research Institute: food diary; malnutrition
• Additional relevant MeSH terms: Malnutrition

Study Results

No Results Posted as of Jun 2, 2022