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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 below
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I plan to start chemotherapy as advised by Moffitt.
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I have been recently diagnosed with advanced or recurrent pancreatic cancer.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days for reporting.

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 more

Trial 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.

Find a Location

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

Group 2: Usual Care Clinical Trial Eligibility Overview. Trial Name: NCT05675059 — N/A
Pancreatic Cancer Research Study Groups: Group 2: Usual Care, Group 1: STRONG Intervention
Pancreatic Cancer Clinical Trial 2023: Group 2: Usual Care Highlights & Side Effects. Trial Name: NCT05675059 — N/A
Group 2: Usual Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05675059 — N/A

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
~28 spots leftby Dec 2024