GI CancerNCT04091165
Mobile APP Utilization for Enhanced Post-Operative Nutritional Recovery
An observational study of GI Cancer and Nutritional Deficiency, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GI Cancer, Nutritional Deficiency
- What is being tested?
- My Plate Calorie Tracker
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2019to 7 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for surgery in the Moffitt GI Clinic
Who may be able to join
- 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
Who cannot join
- Participants with tube feeds and/or need for parenteral/enteral nutrition
- Participants not willing to download or utilize the commercially available weight monitoring application
Trial locations and contacts
1 site in 1 country.
United States1 site
H Lee Moffitt Cancer & Research Institute
Tampa, Florida, 33612
About this study
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.
- Conditions
- GI Cancer, Nutritional Deficiency
- Being tested
- My Plate Calorie Tracker
- Keywords
- food diary, malnutrition
- Medical subject headings
- Gastrointestinal Neoplasms, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My Plate Calorie TrackerOther
Also called mobile application
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.
| Study group | Role | What they receive |
|---|---|---|
| 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". Receives: Other: My Plate Calorie Tracker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of Smart Phone Application
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.
Measured: Up to 3 months
Acceptability of Smart Phone Application
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.
Measured: Up to 3 months
Secondary outcomes (1)
Adherence to Recommended Nutritional Plan
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.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start23 Sep 2019
- Primary completion23 Jul 2020
- Study completion7 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GI CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pamela Hodul, MD, Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091165
- Sponsor's protocol ID
- MCC-19978
- Status last verified
- Apr 2023
- First submitted
- 12 Sep 2019
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Allenson K, Turner K, Gonzalez BD, Gurd E, Zhu S, Misner N, Chin A, Adams M, Cooper L, Nguyen D, Naffouje S, Castillo DL, Kocab M, James B, Denbo J, Pimiento JM, Malafa M, Powers BD, Fleming JB, Anaya DA, Hodul PJ. Pilot trial of remote monitoring to prevent malnutrition after hepatopancreatobiliary surgery. BMC Nutr. 2021 Dec 9;7(1):82. doi: 10.1186/s40795-021-00487-3.
PubMed 34886909
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile APP Utilization for Enhanced Post-Operative Nutritional Recovery
- ClinicalTrials.gov ID
- NCT04091165
- Acronym / sponsor ID
- MCC-19978
- Conditions
- GI Cancer, Nutritional Deficiency
- Keywords
- food diary, malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 23 Jul 2020 (actual)
- Study completion
- 7 Jan 2022 (actual)
- First posted
- 16 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: My Plate Calorie TrackerParticipants 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". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for surgery in the Moffitt GI Clinic
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Participants with tube feeds and/or need for parenteral/enteral nutrition
- Participants not willing to download or utilize the commercially available weight monitoring application
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| My Plate Calorie TrackerAlso: mobile applicationMy 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 | Study Group |
Primary outcome
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.
1 secondary outcome
Adherence to Recommended Nutritional Plan
Time frame: Up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Derived from this study: PubMed 34886909Allenson K, Turner K, Gonzalez BD, Gurd E, Zhu S, Misner N, Chin A, Adams M, Cooper L, Nguyen D, Naffouje S, Castillo DL, Kocab M, James B, Denbo J, Pimiento JM, Malafa M, Powers BD, Fleming JB, Anaya DA, Hodul PJ. Pilot trial of remote monitoring to prevent malnutrition after hepatopancreatobiliary surgery. BMC Nutr. 2021 Dec 9;7(1):82. doi: 10.1186/s40795-021-00487-3.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela Hodul, MD principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GI Cancer and Nutritional Deficiency, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of Smart Phone Application (time frame: Up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04091165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.