Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer
NCT Number: NCT06497569
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: GastroEsophageal Cancer
Interventions: BEHAVIORAL: Dietitian Consultation|BEHAVIORAL: Survey|BEHAVIORAL: Fitbit Data Collection|BEHAVIORAL: Referral to Dietitian|BEHAVIORAL: Social Determinants of Health Survey (SDOH)
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Collaborators: United States Department of Defense
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-06-17
Completion Date: 2027-06
Locations: Moffitt Cancer Center, Tampa, Florida, 33612, United States

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

Primary Outcome Measures: Recruitment Rate- Feasibility, The Study will be deemed feasible ≥ 50% of eligible patients are enrolled., 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., 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., 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)., 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., 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, 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)., 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., Up to 6 Months
Secondary Outcome Measures: 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)., Baseline, 3 Months, 6 Months|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., Baseline, 3 Months, 6 Months|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., Baseline, 3 Months, 6 Months|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., Baseline, 3 Months, 6 Months|Quality of Life Questionnaires, Quality of Life will be measured using the Functional Assessment of Cancer Therapy - General (FACT-G) Scale and the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) subscales.

(FACT-G) and (FAACT) Questionnaires include questions about the participant's physical, social, emotional and functional well-being over the past 7 days. This questionnaire uses a 5 point Likert-type scale, 0=not at all, 4=very much. A higher score indicates a better quality of life., Baseline, 3 Months, 6 Months|Treatment Adherence, Treatment Adherence will be measured by obtaining scheduling and electronic health record (EHR) data to estimate adherence to chemotherapy and/or radiation therapy.

Comparison of will be made of planned vs. received chemotherapy and/or radiation regimens to define 1) treatment delay (yes/no); 2) dose reduction (yes/no); and 3) treatment discontinuation (yes/no). We will also document receipt of surgery (yes/no)., Baseline, 3 Months, 6 Months|Progression Free Survival (PFS), Progression Free Survival (PFS) status will be obtained from the cancer center registry to estimate overall survival (the time from random assignment to death from any cause) and progression-free survival (the time from random assignment to disease progression or death from any cause)., Up to 48 Months