Remote Nutrition Support for Gastroesophageal Cancer

(STRONG-GEC Trial)

Overseen By Emma Hume

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Psychiatric disorders, Neurological disorders, Secondary cancer, Feeding tubes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

23 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{3 4 8 9 10}

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

Kea Turner, PhD

Principal Investigator

Moffitt Cancer Center

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

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

Group I: STRONG-GEC Experimental Treatment 3 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.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Diet Tracking Smartphone Application Keenoa™: A Qualitative Analysis. Bouzo, V., Plourde, H., Beckenstein, H., et al.[2022]

A survey of 1001 healthcare professionals revealed that while 45.5% have recommended nutrition and diet (ND) apps to patients, a significant portion (22.5%) are unaware of such apps, indicating a need for better awareness and education about these tools.

Key features that healthcare professionals look for in ND apps include ease of use (87.1%), being free of charge (72.6%), and having validated information (69%), while barriers to adoption include concerns about inaccurate food databases and lack of local food support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Healthcare Professionals Think of "Nutrition & Diet" Apps: An International Survey. Vasiloglou, MF., Christodoulidis, S., Reber, E., et al.[2021]

A study with 50 participants showed that high personalization in nutrition support, which included video calls with a dietitian and dietary self-monitoring, led to significantly greater improvements in diet quality compared to low personalization using only a web-based report.

Participants in the high personalization group experienced notable dietary changes, including increased intake of healthy foods and reduced consumption of energy-dense, nutrient-poor foods, highlighting the effectiveness of combining technology with personalized dietary advice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact on Dietary Intake of Two Levels of Technology-Assisted Personalized Nutrition: A Randomized Trial. Rollo, ME., Haslam, RL., Collins, CE.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Cachexia and Dietetic Interventions in Patients With Esophagogastric Cancer: A Multicenter Cohort Study. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Assessment of energy intake and total energy expenditure in a series of patients who have undergone oesophagectomy following neoadjuvant treatment. [2021]

3. England pubmed.ncbi.nlm.nih.gov

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]

4. Germany pubmed.ncbi.nlm.nih.gov

The roles of the dietitian in an 18-week telephone and mobile application nutrition intervention for upper gastrointestinal cancer: a qualitative analysis. [2023]

5. Canada pubmed.ncbi.nlm.nih.gov

Attitudes of Australian Patients Undergoing Treatment for Upper Gastrointestinal Cancers to Different Models of Nutrition Care Delivery: Qualitative Investigation. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Usability of myfood24 Healthcare and Mathematical Diet Optimisation in Clinical Populations: A Pilot Feasibility Randomised Controlled Trial. [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

Evaluation of the Diet Tracking Smartphone Application Keenoa™: A Qualitative Analysis. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

An integrated Diet Monitoring Solution for nutrigenomic research. [2016]

9. Switzerland pubmed.ncbi.nlm.nih.gov

What Healthcare Professionals Think of "Nutrition & Diet" Apps: An International Survey. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Impact on Dietary Intake of Two Levels of Technology-Assisted Personalized Nutrition: A Randomized Trial. [2021]