Recruiting NCT06497569
Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dietitian Consultation, Survey, Fitbit Data Collection, Referral to Dietitian.
- Who it may be relevant to
- Registry conditions: GastroEsophageal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer (STRONG-GEC)
Overview
The purpose of this study is to determine how the STRONG intervention compares with usual care for reducing malnutrition among gastroesophageal cancer patients.
Interventions
- 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 t - 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
Primary outcome measures
- Recruitment Rate- Feasibility [Time frame: Up to 48 Months]
- Retention Rate- Feasibility [Time frame: Up to 90 Days]
- Patient-reported outcome completion-Feasibility [Time frame: Up to 6 Months]
- Food Log Data Collection-Feasibility [Time frame: Up to 6 Months]
- Adherence to Dietitian Visits- Feasibility [Time frame: Up to 6 Months]
- Fidelity to Study Protocol- Feasibility [Time frame: Up to 6 Months]
- Patient Rating of MyPlate app-Feasibility [Time frame: Up to 6 Months]
- Participant Satisfaction- Acceptability [Time frame: Up to 6 Months]
Secondary outcome measures (7)
- Malnutrition -Nutritional Status [Time frame: Baseline, 3 Months, 6 Months]
- Malnutrition-Significant weight loss [Time frame: Baseline, 3 Months, 6 Months]
- Malnutrition - Low BMI [Time frame: Baseline, 3 Months, 6 Months]
- Malnutrition - Low Skeletal Muscle Mass [Time frame: Baseline, 3 Months, 6 Months]
- Quality of Life Questionnaires [Time frame: Baseline, 3 Months, 6 Months]
- Treatment Adherence [Time frame: Baseline, 3 Months, 6 Months]
- Progression Free Survival (PFS) [Time frame: Up to 48 Months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 2 centers
- Moffitt Cancer Center — Tampa
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill
Publications
- Turner 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/s41043-02 PMID 41457289
Identifiers
NCT: NCT06497569 · MCC-23230