Support Through Remote Observation and Nutrition Guidance for Gastroesophageal Cancer
This study, called STRONG, is looking at how a special program of remote nutrition support compares to usual care for people with gastroesophageal cancer (cancer of the stomach or esophagus). The program involves regular dietitian consultations through video calls, tracking food intake with a Fitbit, and completing surveys about symptoms and social factors. You might be able to join if you are 18 or older, have locally advanced or metastatic gastroesophageal cancer, and are starting chemotherapy and/or radiation therapy with plans for surgery or definitive treatment at Moffitt. The study aims to see if this program can help reduce malnutrition. The current status of the study is unclear, and it plans to enroll 80 participants.
- Study design
- This interventional study plans to enroll 80 participants. It compares a remote nutrition guidance program to standard care.
- What's involved
- You would meet with a dietitian bi-weekly via ZOOM, complete surveys, and log food intake using a Fitbit for up to 90 days during the intervention period, with follow-up at 4 and 6 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 6 months after the intervention period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer
At a glance
Conditions
NCT06497569
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Moffitt Cancer Center
Tampa, Floridastudy coordinator listed
Recruiting
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolinastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Amir Alishahi Tabriz, MD, PhD, MPH · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center
- Jose Pimiento, MD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center
Who to contact
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Inclusion
Exclusion
What this trial measures
- Recruitment Rate- FeasibilityUp to 48 Months
The Study will be deemed feasible ≥ 50% of eligible patients are enrolled.
- Retention Rate- FeasibilityUp to 90 Days
The Study will be deemed feasible if ≥ 70% of participants enrolled at baseline are retained at the end of the intervention period.
- Patient-reported outcome completion-FeasibilityUp to 6 Months
The Study will be deemed feasible if ≥ 70% of participants enrolled submit 4 of the 6 study assessments.
- Food Log Data Collection-FeasibilityUp to 6 Months
The study will be deemed feasible if ≥ 70% of participants enrolled log food for greater than 80% of study days (72 out of 90).
- Adherence to Dietitian Visits- FeasibilityUp to 6 Months
The Study will be deemed feasible if ≥ 70% of participants enrolled attend 4 out of 6 dietitian visits.
- Fidelity to Study Protocol- FeasibilityUp to 6 Months
The Study will be deemed feasible if 20% of randomly audited dietitian visits have documented PG-SGA and calorie and protein goals
- Patient Rating of MyPlate app-FeasibilityUp to 6 Months
The Study will be deemed feasible if ≥ 70% of participants rate the MyPlate app as east-to use utilizing a validated usability scale (score ≥ 60).
- Participant Satisfaction- AcceptabilityUp to 6 Months
Patient satisfaction with the intervention will be deemed acceptable if ≥ 70% of participants rate the intervention as satisfactory utilizing a validated 4 item scale (score range 0-20). A cutoff score of ≥ 12 based on prior studies to define intervention acceptability will be used.