Clinical trial · Interventional
Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer
Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer (STRONG-GEC)
NCT06497569CI-TRIAL-00106966recruitingN/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 this study is to determine how the STRONG intervention compares with usual care for reducing malnutrition among gastroesophageal cancer patients.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dietitian Consultation | Behavioral | — | UNRESOLVED |
| Fitbit Data Collection | Behavioral | — | UNRESOLVED |
| Referral to Dietitian | Behavioral | — | UNRESOLVED |
| Social Determinants of Health Survey (SDOH) | Behavioral | — | UNRESOLVED |
| Survey | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- STRONG Intervention
- description
- Participants will receive an initial consultation and biweekly follow-up visits with a study dietitian for 90 days. During the follow-up visits, the study dietitian will review the dietary plan and goals, review the dietary food log, and discuss any challenges with dietary intake and recommendations for improving dietary intake. Participants will keep a daily diary of food intake with a Fitbit smartphone app and a Fitbit wearable device for 90 days, complete 6 questionnaires, and have the option to participate in a voluntary interview about the intervention.
- interventionNames
- Behavioral: Dietitian Consultation
- Behavioral: Survey
- Behavioral: Fitbit Data Collection
- Behavioral: Social Determinants of Health Survey (SDOH)
- type
- ACTIVE_COMPARATOR
- label
- Usual Care Intervention
- description
- Participants will be referred to a study dietitian based on their standard-care clinician's discretion, complete 6 questionnaires, and have the option to participate in a voluntary interview about the intervention.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants must be 18 years of age or older * Participants must have locally advanced or metastatic gastroesophageal cancer (GEC) * Participants must plan to initiate chemotherapy and/or radiation therapy with a plan to have surgery or definitive treatment follow up at Moffitt * Participants must be able to speak and read Spanish and/or English * Participants must be able to provide informed consent Exclusion Criteria: * Participants have a documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g. severe dementia) * Use of feeding tubes at the time of study enrollment
References
Publications (1)
- DERIVEDTurner K, Somasundaram A, Small BJ, Milano J, Santiago C, Sprow O, Hume E, Khajoueinejad N, McKinnie N, Pereira AL, Sinnamon A, Permuth JB, Tabriz AA, Pimiento JM. A patient-mediated implementation strategy to improve nutrition care delivery for esophageal and gastric cancer: a study protocol for a pilot randomized controlled trial. J Health Popul Nutr. 2025 Dec 28;45(1):37. doi: 10.1186/s41043-025-01208-3. PMID 41457289