Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer (STRONG-GEC)
Summary
The purpose of this study is to determine how the STRONG intervention compares with usual care for reducing malnutrition among gastroesophageal cancer patients.
Arms & interventions
- BehavioralDietitian 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.
- BehavioralSurvey
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.
- BehavioralFitbit 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.
- BehavioralReferral to Dietitian
Usual Care condition referral to a dietitian based on physician discretion.
- BehavioralSocial 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).
Outcome measures
Primary
Recruitment Rate- Feasibility
The Study will be deemed feasible ≥ 50% of eligible patients are enrolled.
Time frame: Up to 48 Months
Retention Rate- Feasibility
The Study will be deemed feasible if ≥ 70% of participants enrolled at baseline are retained at the end of the intervention period.
Time frame: Up to 90 Days
Patient-reported outcome completion-Feasibility
The Study will be deemed feasible if ≥ 70% of participants enrolled submit 4 of the 6 study assessments.
Time frame: Up to 6 Months
Food Log Data Collection-Feasibility
The study will be deemed feasible if ≥ 70% of participants enrolled log food for greater than 80% of study days (72 out of 90).
Time frame: Up to 6 Months
Adherence to Dietitian Visits- Feasibility
The Study will be deemed feasible if ≥ 70% of participants enrolled attend 4 out of 6 dietitian visits.
Time frame: Up to 6 Months
Fidelity to Study Protocol- Feasibility
The Study will be deemed feasible if 20% of randomly audited dietitian visits have documented PG-SGA and calorie and protein goals
Time frame: Up to 6 Months
Patient Rating of MyPlate app-Feasibility
The Study will be deemed feasible if ≥ 70% of participants rate the MyPlate app as east-to use utilizing a validated usability scale (score ≥ 60).
Time frame: Up to 6 Months
Participant Satisfaction- Acceptability
Patient satisfaction with the intervention will be deemed acceptable if ≥ 70% of participants rate the intervention as satisfactory utilizing a validated 4 item scale (score range 0-20). A cutoff score of ≥ 12 based on prior studies to define intervention acceptability will be used.
Time frame: Up to 6 Months
Secondary
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
Study locations (2)
Moffitt Cancer Center
Tampa, Florida, 33612
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
References
- 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/s41043-025-01208-3.(PubMed)