Recruiting

Observational Study

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT06497569

Conditions

GastroEsophageal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dietitian Consultation

Survey

Fitbit Data Collection

Referral to Dietitian

Social Determinants of Health Survey (SDOH)

Study Details

Brief summary:

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

Conditions

GastroEsophageal Cancer

Study ID

NCT06497569

Start date

Jul 26, 2024

Status verified date

Mar, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

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.

Referral to Dietitian

Usual Care condition referral to a dietitian based on physician discretion.

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).

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Principal Investigator:

Amir Alishahi Tabriz, MD, phD, MPH

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Kea Turner, PhD, MPH, MA

919-966-4432Kea.Turner@unc.edu

Principal Investigator:

Kea Turner, PhD, MPH, MA

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Keywords

  • Nutrition Support

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2026-04-01.