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

NARecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

July 26, 2024

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2027

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)."

Trial Locations (2)

27599

RECRUITING

UNC Lineberger Comprehensive Cancer Center, Chapel Hill

33612

RECRUITING

Moffitt Cancer Center, Tampa

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER