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Remote Nutrition Support for Gastroesophageal Cancer (STRONG-GEC Trial)

N/A
Recruiting
Led By Jose M Pimiento, MD
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
Locally advanced or metastatic GEC diagnosis
≥18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

STRONG-GEC Trial Summary

This trial assesses a program that provides remote nutrition support for people with gastroesophageal cancer undergoing chemo and radiation.

Who is the study for?
The STRONG program is for adults over 18 with gastroesophageal cancer who are starting chemoradiation treatment and plan to have surgery at Moffitt. They must be able to understand and speak English, give informed consent, and not use feeding tubes before joining.Check my eligibility
What is being tested?
This study tests the STRONG program's effectiveness in providing nutritional support via Fitbit data collection, nutrition counseling, and surveys for patients undergoing chemotherapy and radiation therapy for gastroesophageal cancer.See study design
What are the potential side effects?
Since this trial focuses on nutrition guidance rather than medication or invasive procedures, side effects may include discomfort from wearing a Fitbit device or emotional distress from dietary changes but are generally expected to be minimal.

STRONG-GEC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is advanced or has spread beyond where it started.
Select...
I am 18 years old or older.
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I am scheduled for chemoradiation or radiation with plans for surgery or definitive treatment at Moffitt.

STRONG-GEC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Data Collection - Feasibility
Participant Rating on Ease of Use the Mobile Application - Usability
Participant Satisfaction - Acceptability
+2 more
Secondary outcome measures
Participant Compliance with Dietary Log - Intervention adherence
Participant Compliance with Dietician Visit - Intervention adherence

STRONG-GEC Trial Design

1Treatment groups
Experimental Treatment
Group I: STRONG-GECExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nutrition Counseling
2015
Completed Phase 2
~320
Survey
2011
N/A
~3710

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
537 Previous Clinical Trials
134,971 Total Patients Enrolled
Jose M Pimiento, MDPrincipal InvestigatorMoffitt Cancer Center
1 Previous Clinical Trials
300 Total Patients Enrolled
Kea Turner, PhDPrincipal InvestigatorMoffitt Cancer Center
3 Previous Clinical Trials
170 Total Patients Enrolled

Media Library

Nutrition Counseling Clinical Trial Eligibility Overview. Trial Name: NCT05438940 — N/A
Gastroesophageal Cancer Research Study Groups: STRONG-GEC
Gastroesophageal Cancer Clinical Trial 2023: Nutrition Counseling Highlights & Side Effects. Trial Name: NCT05438940 — N/A
Nutrition Counseling 2023 Treatment Timeline for Medical Study. Trial Name: NCT05438940 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers are involved in this clinical trial?

"Affirmative. Clinicaltrials.gov declares that this trial, initially added on June 21st 2022, is currently seeking volunteers. Approximately 20 people need to be recruited from one medical centre."

Answered by AI

Is enrolment still open for this trial?

"Affirmative. Clinicaltrials.gov reveals that this medical trial has initiated recruitment, commencing from the 21st of June 2022 and updated on the 29th of June 2022. The research team needs to secure 20 participants for their study at one site."

Answered by AI
~2 spots leftby Jul 2024