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

H. Lee Moffitt Cancer Center and Research Institute

Status: Enrolling

Conditions: GastroEsophageal Cancer

Treatments: Behavioral: Social Determinants of Health Survey (SDOH); Behavioral: Survey; Behavioral: Fitbit Data Collection; Behavioral: Dietitian Consultation; Behavioral: Referral to Dietitian

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06497569

MCC-23230

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

STRONG Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Dietitian Consultation

Behavioral: Fitbit Data Collection

Behavioral: Survey

Behavioral: Social Determinants of Health Survey (SDOH)

Usual Care Intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Referral to Dietitian

Behavioral: Dietitian Consultation

Behavioral: Survey