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Remote Nutrition Support for Gastroesophageal Cancer (STRONG-GEC Trial)

N/A

Waitlist Available

Led By Kea Turner, PhD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Locally advanced or metastatic GEC diagnosis

≥18 years old

Must not have

Undergoing concurrent treatment for a secondary primary cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial assesses a program that provides remote nutrition support for people with gastroesophageal cancer undergoing chemo and radiation.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on nutrition guidance rather than medication or invasive procedures, side effects may include discomfort from wearing a Fitbit device or emotional distress from dietary changes but are generally expected to be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is advanced or has spread beyond where it started.

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I am 18 years old or older.

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I am scheduled for chemoradiation or radiation with plans for surgery or definitive treatment at Moffitt.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently being treated for another type of cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Data Collection - Feasibility

Participant Rating on Ease of Use the Mobile Application - Usability

Participant Satisfaction - Acceptability

+2 more

Secondary study objectives

Participant Compliance with Dietary Log - Intervention adherence

Participant Compliance with Dietician Visit - Intervention adherence

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nutrition Counseling

2015

Completed Phase 2

~320

Survey

2013

N/A

~3730