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Behavioral Intervention

Nutrition Guidance Program for Gastroesophageal Cancer

N/A

Recruiting

Led By Kea Turner, PhD, MA

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be 18 years of age or older

Participants must plan to initiate chemotherapy and/or radiation therapy with a plan to have surgery or definitive treatment follow up at Moffitt

Must not have

Participants have a documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g. severe dementia)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if the STRONG intervention is better than usual care in helping gastroesophageal cancer patients reduce malnutrition.

Who is the study for?

This trial is for individuals with gastroesophageal cancer who may be at risk of malnutrition. Specific eligibility criteria are not provided, but typically participants would need to meet certain health conditions and agree to the study's procedures.

What is being tested?

The STRONG intervention, which includes surveys on health and social factors, consultations with dietitians, referrals as needed, and monitoring activity levels using a Fitbit device, is being tested against usual care practices.

What are the potential side effects?

Since this trial involves non-invasive interventions like surveys and nutritional guidance rather than medication or surgery, side effects are minimal but could include discomfort from wearing the Fitbit or emotional distress from discussing health issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I plan to start chemo or radiation and have surgery at Moffitt.

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My cancer is in the stomach or esophagus and has spread.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a severe mental or neurological condition that would prevent me from participating.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence to Dietitian Visits- Feasibility

Fidelity to Study Protocol- Feasibility

Food Log Data Collection-Feasibility

+5 more

Secondary study objectives

Malnutrition - Low BMI

Malnutrition - Low Skeletal Muscle Mass

Malnutrition -Nutritional Status

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: STRONG InterventionExperimental Treatment4 Interventions

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.

Group II: Usual Care InterventionActive Control3 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Survey

2013

N/A

~3730

0 / 4Eligibility criteria met