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Nutrition Support Program for Gastrointestinal Cancer
N/A
Waitlist Available
Led By Ben Powers, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 weeks
Awards & highlights
Study Summary
This trial assesses how well a program providing nutrition support to people fighting gastrointestinal cancer works.
Who is the study for?
The STRONG program is for individuals with gastrointestinal cancer who've had CRS-HIPEC surgery and are on an oral diet. Participants must be able to understand English and give informed consent. Those with interfering psychiatric conditions, undergoing treatment for another primary cancer, or receiving post-surgery nutrition support can't join.Check my eligibility
What is being tested?
This study tests the STRONG program's effectiveness in providing nutritional guidance through questionnaires, consultations with a dietician, and monitoring daily food intake using a Fitbit app for patients undergoing chemotherapy and surgical treatments.See study design
What are the potential side effects?
Since this trial involves nutritional guidance rather than medication, traditional side effects like those seen with drugs aren't expected. However, participants may experience stress or inconvenience from regular diary keeping and adherence to dietary recommendations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability of the STRONG Program
Adherence to the STRONG Program
Efficacy of STRONG Program on Treatment Outcomes
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: STRONG ProgramExperimental Treatment3 Interventions
the STRONG program includes consultations with a Moffitt dietician, logging intake of food daily into a food diary with a Fitbit smartphone app, and completing questionnaires.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Questionnaires
2013
Completed Phase 2
~3330
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,482 Total Patients Enrolled
Ben Powers, MDPrincipal InvestigatorMoffitt Cancer Center
Kea Turner, PhDPrincipal InvestigatorMoffitt Cancer Center
3 Previous Clinical Trials
180 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a type of gastrointestinal cancer.I am currently being treated for another type of cancer.I received nutrition through a tube or IV after surgery.I have started eating solid foods again after my surgery.I had surgery and heated chemo in my abdomen for cancer treatment at Moffitt.I have been diagnosed with peritoneal disease.
Research Study Groups:
This trial has the following groups:- Group 1: STRONG Program
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.
Are there any unfilled positions for participants in this experiment?
"As indicated on clinicaltrials.gov, this medical experiment is still actively seeking participants and was initially posted to the website on December 1st 2022 with its last update occurring 6 days later."
Answered by AI
How many patients is this trial accommodating?
"Affirmative. According to clinicaltrials.gov, this study is currently accepting participants and was first publicized on December 1st 2022. The most recent update occurred on the 6th of that same month. 10 patients from a single site need to be recruited for successful completion of the trial."
Answered by AI
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