NCT06497569

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine how the STRONG intervention compares with usual care for reducing malnutrition among gastroesophageal cancer patients.

Conditions

• GastroEsophageal Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Dietitian Consultation	Participants will meet with a dietitian who will provide individualized nutrition counseling and dietary goals for calorie and protein intake. Bi-weekly, 30-minute dietitian telehealth visits will be conducted via ZOOM videoconferencing at the pre-intervention baseline visit, monthly during the intervention period (up to 90 days) and at the 4 and 6 month timepoints post-intervention.
BEHAVIORAL	Survey	Surveys will be conducted using the PG-SGA short form19-21 and a brief symptom assessment tool that captures additional nutrition-impact symptoms not captured by the PG-SGA (e.g., swallowing difficulty) measured by the FACT Esophageal and Gastric Cancer scales and the FAACT anorexia/cachexia scales 22,23 through REDCap. Surveys are completed at the pre-intervention baseline visit and monthly during the intervention period prior to the dietitian visits (up to 90 days), and at the 4 and 6 month timepoints post-intervention.
BEHAVIORAL	Fitbit Data Collection	Participants will log food intake while sharing their data with a dietitian during the 30-minute dietitian telehealth visits at the pre-intervention baseline visit, monthly during the intervention period (up to 90 days) and at the 4 and 6 month timepoints post-intervention.
BEHAVIORAL	Referral to Dietitian	Usual Care condition referral to a dietitian based on physician discretion.
BEHAVIORAL	Social Determinants of Health Survey (SDOH)	Participants will complete a SDOH Survey that captures individual-level factors (insurance type, preferred language, educational attainment, annual household income, digital health literacy, financial toxicity, and self-reported barriers to care \[e.g., transportation\]) and structural-level factors (neighborhood disadvantage, rural residence). Digital health literacy will be measured using the validated eHEALS scale, an 8-item measure assessing confidence with finding, evaluating, and applying electronic information to inform health decision-making (score ≤ 30 indicates low literacy).

Timeline

• Start date: 2024-07-26
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2024-07-11
• Last updated: 2026-04-01

Locations

2 sites across 1 country: United States