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

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

Study Overview

• Status: Recruiting
• Conditions: GastroEsophageal Cancer
• Intervention / Treatment: Behavioral: Fitbit Data Collection; Behavioral: Nutrition Counseling; Behavioral: Survey

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emma Hume; Phone Number: 813-745-6426; Email: Emma.Hume@moffitt.org
• Study Contact Backup: Name: Kea Turner, PhD; Phone Number: 813-745-5213; Email: Kea.Turner@moffitt.org

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center
      • Contact: Emma Hume; Phone Number: 813-745-6426; Email: Emma.Hume@moffitt.org
      • Principal Investigator: Jose M Pimiento, MD
      • Sub-Investigator: Jessica Frakes, MD
      • Sub-Investigator: Sarah E Hoffe, MD
      • Sub-Investigator: Jason B Fleming, MD
      • Sub-Investigator: Nate Parker, PhD
      • Principal Investigator: Kea Turner, PhD
      • Sub-Investigator: Rutika Mehta, MD, MPH
      • Sub-Investigator: Mohammed Al-Jumayli, MD
      • Sub-Investigator: Brian Gonzalez, PhD
      • Sub-Investigator: Jenny Permuth, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: STRONG-GEC; 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; Participants will log food intake while sharing their data with a dietician in real time for 12 weeks; Behavioral: Nutrition Counseling; Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth; Behavioral: Survey; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Investigators: Principal Investigator: Kea Turner, PhD, Moffitt Cancer Center; Principal Investigator: Jose M Pimiento, MD, Moffitt Cancer Center

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trial Search

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Nutrition Support
• Other Study ID Numbers: MCC-21889

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No