The purpose of this study is to determine how the STRONG intervention compares with usual care for reducing malnutrition among gastroesophageal cancer patients.
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 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
Parallel
Dietitian Consultation
BehavioralParticipants 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.
Survey
BehavioralSurveys 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.
Fitbit Data Collection
BehavioralParticipants 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.
Referral to Dietitian
BehavioralUsual Care condition referral to a dietitian based on physician discretion.
Social Determinants of Health Survey (SDOH)
BehavioralParticipants 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).
Recruitment Rate- Feasibility
The Study will be deemed feasible ≥ 50% of eligible patients are enrolled.
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.
Patient-reported outcome completion-Feasibility
The Study will be deemed feasible if ≥ 70% of participants enrolled submit 4 of the 6 study assessments.
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).
Malnutrition -Nutritional Status
Nutritional status will be measured using the Patient-Generated Subjective Global Assessment (PG-SGA) Short Form (score range: 0-35) and categorized based on a prior validation study (0-1 well nourished, 2-8 at-risk, ≥ 9 severely malnourished).
Malnutrition-Significant weight loss
Significant weight loss is defined as \>5% and \>10% of body weight. This will be calculated based on weight obtained during clinic visits.
Malnutrition - Low BMI
Low BMI will be defined as \<20kg/m² for individuals \<70 years old and \<22kg/m2 for individuals ≥70 years old. This will be calculated based on weight and height measurements from clinic visits.
Malnutrition - Low Skeletal Muscle Mass
Low muscle mass will be estimated by calculating skeletal muscle index (SMI) from routinely collected CT scans at baseline, 3 months and 6 months (CT scans are conducted every 3 months). Low muscle mass will be defined as SMI ≤38.5 cm2 /m2 for females and SMI ≤52.4 cm2 /m2 for males.
Click on the lead sponsor to view all of their trials.
H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
United States Department of Defense
Collaborator
