Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Gastroesophageal Cancer (GEC) Patients
NCT ID: NCT05438940
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
23 participants
INTERVENTIONAL
2022-07-15
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Fitbit Data Collection
Participants will log food intake while sharing their data with a dietician in real time for 12 weeks
Nutrition Counseling
Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth
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.
Interventions
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Fitbit Data Collection
Participants will log food intake while sharing their data with a dietician in real time for 12 weeks
Nutrition Counseling
Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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H. Lee Moffitt Cancer Center and Research Institute
OTHER
Responsible Party
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Principal Investigators
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Kea Turner, PhD
Role: PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center
Jose M Pimiento, MD
Role: PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center
Locations
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Moffitt Cancer Center
Tampa, Florida, United States
Countries
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References
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Lin YC, Pimiento JM, Milano J, Riccardi D, Mckinnie N, Hume E, Sprow O, Diaz-Carraway S, Budnetz M, Hagen R, Al-Jumayli M, Pereira AL, Sinnamon AJ, Somasundaram A, Permuth JB, Tabriz AA, Turner K. Feasibility trial of STRONG: A digital intervention to improve nutritional management for individuals with esophageal and gastroesophageal junction cancer. Contemp Clin Trials Commun. 2024 Dec 23;43:101421. doi: 10.1016/j.conctc.2024.101421. eCollection 2025 Feb.
Related Links
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Moffitt Cancer Center Clinical Trial Search
Other Identifiers
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MCC-21889
Identifier Type: -
Identifier Source: org_study_id
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