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

NCT ID: NCT05438940

Last Updated: 2025-12-04

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-15

Study Completion Date

2026-06-30

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

Detailed Description

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Conditions

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GastroEsophageal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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.

Group Type EXPERIMENTAL

Fitbit Data Collection

Intervention Type BEHAVIORAL

Participants will log food intake while sharing their data with a dietician in real time for 12 weeks

Nutrition Counseling

Intervention Type BEHAVIORAL

Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth

Survey

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Nutrition Counseling

Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth

Intervention Type 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.

Intervention Type BEHAVIORAL

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 39810840 (View on PubMed)

Related Links

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Other Identifiers

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MCC-21889

Identifier Type: -

Identifier Source: org_study_id

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