23 Participants Needed

Remote Nutrition Support for Gastroesophageal Cancer

(STRONG-GEC Trial)

AH
KT
EH
Overseen ByEmma Hume
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on nutrition support during cancer treatment, so it's best to ask the trial coordinators for more details.

What data supports the effectiveness of the treatment Remote Nutrition Support for Gastroesophageal Cancer?

Research shows that early and intensive nutrition care, delivered via phone or mobile app, can improve quality of life for people with upper gastrointestinal cancer. This approach helps manage malnutrition, which is common in these patients and linked to worse health outcomes.12345

Is remote nutrition support safe for humans?

The studies reviewed did not report any safety concerns related to using diet tracking apps or remote nutrition support, suggesting these methods are generally safe for human use.678910

How does the Remote Nutrition Support treatment for gastroesophageal cancer differ from other treatments?

This treatment is unique because it uses mobile health (mHealth) technology to provide early and intensive nutrition support remotely, before patients are admitted to the hospital. This approach aims to improve nutritional status and quality of life by connecting patients with dietitians through phone calls or mobile apps, which is not a standard practice in traditional cancer care.348910

What is the purpose of this trial?

The purpose of the study is to assess the feasibility and patient satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides nutrition support for participants living with gastroesophageal cancer who are receiving chemotherapy and radiation treatment

Research Team

Moffitt Cancer Center ...

Kea Turner, PhD

Principal Investigator

Moffitt Cancer Center

Dr. Jose Pimiento Appointed American ...

Jose M Pimiento, MD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

The STRONG program is for adults over 18 with gastroesophageal cancer who are starting chemoradiation treatment and plan to have surgery at Moffitt. They must be able to understand and speak English, give informed consent, and not use feeding tubes before joining.

Inclusion Criteria

My cancer is advanced or has spread beyond where it started.
I am scheduled for chemoradiation or radiation with plans for surgery or definitive treatment at Moffitt.
Able to provide informed consent
See 1 more

Exclusion Criteria

I do not use a feeding tube.
Documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g., psychosis, active substance abuse)
I am currently being treated for another type of cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy and Radiation Treatment

Participants receive chemotherapy and radiation treatment while participating in the STRONG program, which includes bi-weekly nutrition counseling and remote monitoring

12 weeks
Bi-weekly telehealth visits with a dietician

Follow-up

Participants are monitored for safety and effectiveness after treatment, including retention and compliance assessments

12 months

Treatment Details

Interventions

  • Fitbit Data Collection
  • Nutrition Counseling
  • Survey
Trial Overview This study tests the STRONG program's effectiveness in providing nutritional support via Fitbit data collection, nutrition counseling, and surveys for patients undergoing chemotherapy and radiation therapy for gastroesophageal cancer.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: STRONG-GECExperimental Treatment3 Interventions
Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth and remote monitoring through a smart phone app and wearable sensor to allow participants to log food intake while sharing their data with a dietician.

Find a Clinic Near You

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials
576
Recruited
145,000+

Findings from Research

This study aims to evaluate the effectiveness of early nutrition intervention delivered via telephone or mobile health (mHealth) for patients with upper gastrointestinal cancers, with a focus on improving quality of life and nutritional status over an 18-week period.
The trial involves 18 weeks of tailored nutritional support for participants, with the hypothesis that those receiving early intervention will experience more quality-adjusted life years compared to those receiving standard care, highlighting the potential of mHealth in cancer treatment.
Effect of early and intensive nutrition care, delivered via telephone or mobile application, on quality of life in people with upper gastrointestinal cancer: study protocol of a randomised controlled trial.Hanna, L., Huggins, CE., Furness, K., et al.[2019]
The 'myfood24 Healthcare' app was found to be acceptable for both patients and healthcare professionals in a feasibility study involving 48 participants from weight management and gastroenterology surgery programs.
Compliance with the app was reasonable, with 50% of users recording their dietary intake for four or more days, indicating potential for effective dietary monitoring and support in clinical settings.
Usability of myfood24 Healthcare and Mathematical Diet Optimisation in Clinical Populations: A Pilot Feasibility Randomised Controlled Trial.Threapleton, DE., Beer, SL., Foley, DJ., et al.[2023]
The Keenoa™ app was preferred over traditional pen and paper methods for diet recording among participants, indicating a positive user experience with digital data collection.
While the app had strengths like picture recognition and a pleasant interface, challenges such as barcode scanning issues and a limited food database were noted, suggesting areas for improvement to enhance its efficacy.
Evaluation of the Diet Tracking Smartphone Application Keenoa™: A Qualitative Analysis.Bouzo, V., Plourde, H., Beckenstein, H., et al.[2022]

References

Cachexia and Dietetic Interventions in Patients With Esophagogastric Cancer: A Multicenter Cohort Study. [2021]
Assessment of energy intake and total energy expenditure in a series of patients who have undergone oesophagectomy following neoadjuvant treatment. [2021]
Effect of early and intensive nutrition care, delivered via telephone or mobile application, on quality of life in people with upper gastrointestinal cancer: study protocol of a randomised controlled trial. [2019]
The roles of the dietitian in an 18-week telephone and mobile application nutrition intervention for upper gastrointestinal cancer: a qualitative analysis. [2023]
Attitudes of Australian Patients Undergoing Treatment for Upper Gastrointestinal Cancers to Different Models of Nutrition Care Delivery: Qualitative Investigation. [2021]
Usability of myfood24 Healthcare and Mathematical Diet Optimisation in Clinical Populations: A Pilot Feasibility Randomised Controlled Trial. [2023]
Evaluation of the Diet Tracking Smartphone Application Keenoa™: A Qualitative Analysis. [2022]
An integrated Diet Monitoring Solution for nutrigenomic research. [2016]
What Healthcare Professionals Think of "Nutrition & Diet" Apps: An International Survey. [2021]
Impact on Dietary Intake of Two Levels of Technology-Assisted Personalized Nutrition: A Randomized Trial. [2021]
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