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Nutrition Support Program for Pancreatic Cancer
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
Planning to initiate chemotherapy under the guidance of Moffitt
Newly diagnosed metastatic or newly recurrent pancreatic cancer or locally advanced pancreatic cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 90 days
Awards & highlights
Study Summary
This trial assesses how well a program providing additional dietician access and nutrition support helps people living with pancreatic cancer receiving chemo.
Who is the study for?
This trial is for adults over 18 with new or returning pancreatic cancer who are starting chemotherapy. They must be able to understand and speak English, give informed consent, and not have any serious psychiatric issues or other GI cancers.Check my eligibility
What is being tested?
The STRONG program's effectiveness is being tested. It includes a daily food diary app, questionnaires, and regular consultations with a dietician to support the nutrition of those undergoing chemo for pancreatic cancer.See study design
What are the potential side effects?
There may not be direct side effects from the interventions as they involve nutritional guidance rather than medication. However, participants might experience stress or discomfort related to frequent monitoring of their diet.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I plan to start chemotherapy as advised by Moffitt.
Select...
I have been recently diagnosed with advanced or recurrent pancreatic cancer.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 90 days
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
Feasibility of the STRONG Program
Malnutrition: Low BMI
+3 moreTrial Design
2Treatment groups
Active Control
Group I: Group 2: Usual CareActive Control3 Interventions
Participants will be referred to dieticians based on clinical discretion. Participants will also be asked to wear a Fitbit for 12 weeks to passively collect data on activity level.
Group II: Group 1: STRONG InterventionActive Control3 Interventions
The STRONG program includes consultation with a Moffit dietician, logging intake of food daily into a food diary with a Fitbit smartphone app, and completing questionnaires.
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Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
540 Previous Clinical Trials
135,355 Total Patients Enrolled
Pancreatic Cancer Action NetworkOTHER
5 Previous Clinical Trials
13,381 Total Patients Enrolled
Kea Turner, PhDPrincipal InvestigatorMoffitt Cancer Center
3 Previous Clinical Trials
110 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I plan to start chemotherapy as advised by Moffitt.I am currently being treated for another primary cancer in my digestive system.I have been recently diagnosed with advanced or recurrent pancreatic cancer.I am 18 years old or older.I have fluid buildup due to cancer in my abdomen.You are receiving nutrition through a feeding tube or intravenous (IV) line.I need some help with my daily activities.I have received chemotherapy for recurrent pancreatic cancer in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2: Usual Care
- Group 2: Group 1: STRONG Intervention
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 still opportunities to take part in this clinical inquiry?
"As per information furnished on clinicaltrials.gov, the recruitment process for this experiment is ongoing. It was first announced on December 6th 2022 and revised most recently on December 21st 2022."
Answered by AI
How many participants are currently enrolled in this research?
"Affirmative. Information on clinicaltrials.gov suggests that this medical research, which was initially uploaded to the website on December 6th 2022, is in need of participants. 80 individuals must be recruited from a single location for the study to progress."
Answered by AI
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