Support program for patients with gastroesophageal cancer
Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer (STRONG-GEC)
This study tests if a special support program with nutrition help can improve the health of patients with gastroesophageal cancer compared to regular care during their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Tampa, Florida and 1 other locations) |
| Trial ID | NCT06497569 on ClinicalTrials.gov |
What this trial studies
This program aims to evaluate the effectiveness of the STRONG intervention, which includes dietitian consultations and remote monitoring, in reducing malnutrition among patients with gastroesophageal cancer compared to standard care. Participants will receive personalized nutrition guidance and support while undergoing chemotherapy and/or radiation therapy. The study will also collect data on social determinants of health to better understand the needs of these patients. The intervention is designed to enhance nutritional status and overall well-being during treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with locally advanced or metastatic gastroesophageal cancer who are planning to start chemotherapy or radiation therapy.
Not a fit: Patients with psychiatric or neurological disorders that interfere with participation or those using feeding tubes at enrollment may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve nutritional outcomes and quality of life for patients with gastroesophageal cancer.
How similar studies have performed: Other studies focusing on nutritional interventions in cancer care have shown promising results, indicating that this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tampa, Florida and 1 other locations
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Amir Alishahi Tabriz, MD, PhD, MPH — Moffitt Cancer Center
- Study coordinator: Emma Hume
- Email: Emma.Hume@moffitt.org
- Phone: 813-745-6426
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.