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)

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

Study Overview

• Status: Recruiting
• Conditions: GastroEsophageal Cancer
• Intervention / Treatment: Behavioral: Dietitian Consultation; Behavioral: Survey; Behavioral: Fitbit Data Collection; Behavioral: Social Determinants of Health Survey (SDOH); Behavioral: Referral to Dietitian

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emma Hume; Phone Number: 813-745-6426; Email: Emma.Hume@moffitt.org

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center
      • Contact: Emma Hume; Phone Number: 813-745-6426; Email: Emma.Hume@moffitt.org
      • Principal Investigator: Jose Pimiento, MD
      • Principal Investigator: Amir Alishahi Tabriz, MD, phD, MPH
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • UNC Lineberger Comprehensive Cancer Center
      • Principal Investigator: Kea Turner, PhD, MPH, MA
      • Contact: Kea Turner, PhD, MPH, MA; Phone Number: 919-966-4432; Email: Kea.Turner@unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STRONG Intervention; Participants will receive an initial consultation and biweekly follow-up visits with a study dietitian for 90 days. During the follow-up visits, the study dietitian will review the dietary plan and goals, review the dietary food log, and discuss any challenges with dietary intake and recommendations for improving dietary intake. Participants will keep a daily diary of food intake with a Fitbit smartphone app and a Fitbit wearable device for 90 days, complete 6 questionnaires, and have the option to participate in a voluntary interview about the intervention.	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: 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).
Active Comparator: Usual Care Intervention; Participants will be referred to a study dietitian based on their standard-care clinician's discretion, complete 6 questionnaires, and have the option to participate in a voluntary interview about the intervention.	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: Referral to Dietitian; Usual Care condition referral to a dietitian based on physician discretion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Jose Pimiento, MD, Moffitt Cancer Center; Principal Investigator: Amir Alishahi Tabriz, MD, PhD, MPH, Moffitt Cancer Center

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: July 5, 2024
• First Submitted That Met QC Criteria: July 5, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Nutrition Support
• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: MCC-23230

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No