Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Gastroesophageal Cancer (GEC) Patients

Study Overview
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Brief Summary
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The purpose of the study is to assess the feasibility and patient satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides nutrition support for participants living with gastroesophageal cancer who are receiving chemotherapy and radiation treatment

Official Title
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Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Gastroesophageal Cancer (GEC) Patients

Conditions
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GastroEsophageal Cancer

Intervention / Treatment
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* Behavioral: Fitbit Data Collection
* Behavioral: Nutrition Counseling
* Behavioral: Survey


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years old Locally advanced or metastatic GEC diagnosis Planned to initiate chemoradiation and/or radiation therapy with a plan to have surgery or a plan to have definitive treatment at Moffitt. Able to speak and read English Able to provide informed consent Exclusion Criteria: Documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g., psychosis, active substance abuse) Undergoing concurrent treatment for a secondary primary cancer Use of feeding tubes before enrollment (The last exclusion criterion was included because investigators do not anticipate these participants would benefit from a dietary monitoring intervention)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STRONG-GEC<br>Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth and remote monitoring through a smart phone app and wearable sensor to allow participants to log food intake while sharing their data with a dietician. | Behavioral: Fitbit Data Collection<br>* Participants will log food intake while sharing their data with a dietician in real time for 12 weeks<br>Behavioral: Nutrition Counseling<br>* Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth<br>Behavioral: Survey<br>* Participants will take a survey at baseline and weeks 4,8,12 & 16. (FACT-G) Questionnaire includes questions about participant's physical, social, emotional and functional well being over the past 7 days. This questionnaire uses a 5 point Likert-type scale, 0=not at all, 4=very much. A higher total score indicates better quality of life.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Rate - Feasibility | The study will be deemed feasible if ≥ 50% of eligible participants are enrolled | 12 Months | 
| Retention Rate - Feasibility | The study will be deemed feasible if ≥ 70% of participants enrolled at baseline will be retained at 8 weeks | 12 Months | 
| Data Collection - Feasibility | The study will be deemed feasible if ≥ 60% of participants submit 3/4 study assessments | 12 Months | 
| Participant Satisfaction - Acceptability | The study will be deemed acceptable if ≥ 70% of participants rate the overall intervention as satisfactory using a validated 4-item scale (score range 0-20). | 12 Months | 
| Participant Rating on Ease of Use the Mobile Application - Usability | The study will be deemed usable if ≥ 60% of participants rate the mobile application as easy-to-use for logging dietary intake using a validated 10-item scale (score range from 0-100). | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Compliance with Dietician Visit - Intervention adherence | Intervention adherence will be deemed successful if ≥ 60% of participants meet with a dietician for 4/6 visits | 12 Months | 
| Participant Compliance with Dietary Log - Intervention adherence | Intervention adherence will be deemed successful if ≥ 60% of participants track food intake for 8/12 weeks | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition Support