Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer

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

Interventions

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

Referral to Dietitian

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

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).

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• H. Lee Moffitt Cancer Center and Research Institute

  lead OTHER

Principal Investigators

• Amir Alishahi Tabriz, MD, PhD, MPH · Moffitt Cancer Center

• Jose Pimiento, MD · Moffitt Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-26

Primary Completion

2027-06-30

Completion

2027-06-30

Countries

• United States

Study Locations