Remote Nutrition Support for Gastroesophageal Cancer

(STRONG-GEC Trial)

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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)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness and satisfaction of a remote nutrition program for individuals with gastroesophageal cancer undergoing chemotherapy and radiation. Participants will use a Fitbit and a smartphone app to track their food intake, sharing this data with a dietician who will provide personalized nutrition advice via telehealth. The study seeks participants with advanced gastroesophageal cancer who are beginning treatment and do not currently use feeding tubes. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could improve nutritional support for future patients.

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 prior data suggests that the STRONG program is safe for participants with gastroesophageal cancer?

Research has shown that nutrition counseling is generally safe for people with cancer. Studies indicate that working with a dietitian can improve swallowing and reduce the risk of malnutrition. As a result, patients are more likely to maintain stable weight and strength during treatment.

In the STRONG program, participants use a smartphone app and a wearable sensor to track their food intake and share this information with a dietitian. This tech-based method is non-invasive, meaning it involves no medical procedures, making it very safe.

Overall, evidence suggests that the STRONG program, which combines nutrition counseling with remote monitoring, is well-tolerated and has no reported side effects.12345

Why are researchers excited about this trial?

Researchers are excited about the Remote Nutrition Support for gastroesophageal cancer because it offers a personalized and tech-driven approach to patient care. Unlike traditional treatments that primarily focus on surgery, chemotherapy, or radiation, this method integrates wearable technology and telehealth to provide customized nutrition counseling. By using a smartphone app and Fitbit, patients can log their food intake and share real-time data with a dietician, potentially leading to more effective and tailored nutritional support. This innovative approach could improve patient outcomes by making nutritional care more accessible and responsive to individual needs.

What evidence suggests that the STRONG program's nutrition support could be effective for gastroesophageal cancer patients?

Research has shown that good nutrition can greatly benefit people with gastroesophageal cancer. Personalized nutrition advice plays a crucial role in managing stomach-related issues, improving nutrition levels, and strengthening the immune system. This trial explores the impact of combining nutrition counseling with remote monitoring. Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth, using tools like wearable sensors to provide advice based on real-time information. Studies have found that this kind of support can lessen symptoms like nausea and vomiting. Overall, combining nutrition support with remote monitoring appears promising for improving health during cancer treatment.14567

Who Is on the Research Team?

Dr. Jose Pimiento Appointed American ...

Jose M Pimiento, MD

Principal Investigator

Moffitt Cancer Center

Moffitt Cancer Center ...

Kea Turner, PhD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: STRONG-GECExperimental Treatment3 Interventions

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+

Published Research Related to This Trial

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

Citations

Effectiveness of nutritional support for clinical outcomes in ...Nutritional support, particularly EN and IN, can significantly improve hospitalization outcomes, nutritional status, and immune function.
Nutritional Support Indications in Gastroesophageal Cancer ...The aim of this comprehensive review is to address the available evidence concerning nutritional support in gastroesophageal cancer patients ...
The effect of individual nutrition counseling on the life ...The findings of this study, highlight individual nutritional counseling as a critical component in the comprehensive management of gastric ...
Feasibility trial of STRONG: A digital intervention to ...Nutritional interventions for esophageal and GEJ cancer patients have shown promising but inconsistent results across various studies and different patient ...
Nutrition Interventions in the Treatment of Gastrointestinal ...Meta analyses indicated that collectively (all interventions combined), nutrient supplementation reduced nausea, vomiting, and diarrhea incidence (all P < 0.001) ...
Investigating Nutrition and Supportive Care Needs in ...The present study explored the risk of malnutrition, severity of GI symptoms, quality of life, and psychological well-being in esophageal and gastric cancer ...
Nutrition Assessment and Counseling in Integrative Cancer ...Nutrition guidance can affect treatment and survival outcomes for patients with cancer. The effect of a single nutrition consult on patient ...
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