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Remote Nutrition Support for Gastroesophageal Cancer (STRONG-GEC Trial)
N/A
Recruiting
Led By Kea Turner, PhD
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 belowSelect...
My cancer is advanced or has spread beyond where it started.
Select...
I am 18 years old or older.
Select...
I am scheduled for chemoradiation or radiation with plans for surgery or definitive treatment at Moffitt.
STRONG-GEC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
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 moreSecondary 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
542 Previous Clinical Trials
135,472 Total Patients Enrolled
Kea Turner, PhDPrincipal InvestigatorMoffitt Cancer Center
3 Previous Clinical Trials
170 Total Patients Enrolled
Jose M Pimiento, MDPrincipal InvestigatorMoffitt Cancer Center
1 Previous Clinical Trials
300 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not use a feeding tube.My cancer is advanced or has spread beyond where it started.I am scheduled for chemoradiation or radiation with plans for surgery or definitive treatment at Moffitt.I am 18 years old or older.I am currently being treated for another type of cancer.
Research Study Groups:
This trial has the following groups:- Group 1: STRONG-GEC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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