Clinical trial · Interventional
Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Gastroesophageal Cancer (GEC) Patients
NCT05438940CI-TRIAL-00119983STRONG-GECcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| GastroEsophageal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fitbit Data Collection | Behavioral | — | UNRESOLVED |
| Nutrition Counseling | Behavioral | — | UNRESOLVED |
| Survey | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- STRONG-GEC
- description
- 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.
- interventionNames
- Behavioral: Fitbit Data Collection
- Behavioral: Nutrition Counseling
- Behavioral: Survey
Primary outcomes (5)
- measure
- Recruitment Rate - Feasibility
- timeFrame
- 12 Months
- description
- The study will be deemed feasible if ≥ 50% of eligible participants are enrolled
- measure
- Retention Rate - Feasibility
- timeFrame
- 12 Months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥18 years old * Locally advanced or metastatic GEC diagnosis * Planned to initiate chemoradiation and/or radiation therapy with a plan to have surgery or a plan to have definitive treatment at Moffitt. * Able to speak and read English * Able to provide informed consent Exclusion Criteria: * Documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g., psychosis, active substance abuse) * Undergoing concurrent treatment for a secondary primary cancer * Use of feeding tubes before enrollment (The last exclusion criterion was included because investigators do not anticipate these participants would benefit from a dietary monitoring intervention)
References
Publications (1)
- DERIVEDLin YC, Pimiento JM, Milano J, Riccardi D, Mckinnie N, Hume E, Sprow O, Diaz-Carraway S, Budnetz M, Hagen R, Al-Jumayli M, Pereira AL, Sinnamon AJ, Somasundaram A, Permuth JB, Tabriz AA, Turner K. Feasibility trial of STRONG: A digital intervention to improve nutritional management for individuals with esophageal and gastroesophageal junction cancer. Contemp Clin Trials Commun. 2024 Dec 23;43:101421. doi: 10.1016/j.conctc.2024.101421. eCollection 2025 Feb. PMID 39810840