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Support and Nutrition Guidance for Pancreatic Cancer (STRONG-PCS Trial)

Q: Is enrollment available for this exploration currently?

<p>Clinicaltrials.gov verifies that this medical trial, initially introduced on August 14th 2023, is still recruiting patients. The most recent update was made on the 18th of August in the same year.</p>

Q: How many individuals have been approved to partake in this research experiment?

<p>Affirmative. Clinicaltrials.gov reports that this medical trial is currently enrolling participants, which were posted on August 14th 2023 and last modified on the 18th of the same month. A total of 80 persons are needed to be recruited from one dedicated centre.</p>

N/A

Recruiting

Led By Pamela J Hodul, 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

Completed open pancreatic surgery (e.g., Whipple, distal/subtotal pancreatectomy, total pancreatectomy) for treatment at Moffitt Cancer Center

Diagnosis of pancreatic cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 months

Awards & highlights

STRONG-PCS Trial Summary

This trial will study a program that gives pancreatic cancer patients more support and nutrition guidance during surgery.

Who is the study for?

This trial is for adults over 18 with pancreatic cancer who've had certain types of surgery at Moffitt Cancer Center and are on an oral diet. They must be able to understand English or Spanish and give informed consent. It's not for those deemed unsuitable for surgery due to advanced cancer.Check my eligibility

What is being tested?

The STRONG-PCS program is being tested, which includes enhanced dietician access and nutrition support using surveys, Fitbit data collection, and nutrition counseling for patients recovering from pancreatic cancer surgery.See study design

What are the potential side effects?

Since this study focuses on nutritional guidance rather than medication or invasive procedures, side effects may include discomfort from wearing a Fitbit device or potential emotional impacts from discussing dietary habits.

STRONG-PCS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had pancreatic surgery at Moffitt Cancer Center.

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I have been diagnosed with pancreatic cancer.

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I am 18 years old or older.

STRONG-PCS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 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

Hospital Readmissions

Malnutrition - Low BMI

Malnutrition - Low Skeletal Muscle Mass

+3 more

STRONG-PCS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: STRONG-PCS InterventionExperimental Treatment3 Interventions

Participants will receive an initial in-person consultation with a dietician within 2 weeks of hospital discharge. Then participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth or in person 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.

Group II: Usual CareActive Control2 Interventions

Participants will be referred for nutrition counseling from a dietitian based on clinical discretion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Survey

2011

N/A

~3710

Nutrition Counseling

2015

Completed Phase 2

~320

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

543 Previous Clinical Trials

135,402 Total Patients Enrolled

United States Department of DefenseFED

865 Previous Clinical Trials

327,619 Total Patients Enrolled

Pamela J Hodul, MDPrincipal InvestigatorMoffitt Cancer Center

Frequently Asked Questions

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

What goals does this trial strive to accomplish?

"The primary benchmark for this trial, which will span up to 48 months in length, is the Retention Rate - Feasibility. Additional outcomes include malnutrition (low BMI and low skeletal muscle mass) as well as quality of life using a 5 point Likert-type scale. Low BMI is defined as <20kg/m² for patients under 70 years old while those over that age must have a score below 22 kg/m2. Skeletal Muscle Index will also be used when estimating patient's low muscle mass; females need an SMI ≤38.9 cm2 /m2 and males require a SMI ≤55"

Answered by AI

Is enrollment available for this exploration currently?

"Clinicaltrials.gov verifies that this medical trial, initially introduced on August 14th 2023, is still recruiting patients. The most recent update was made on the 18th of August in the same year."

Answered by AI

How many individuals have been approved to partake in this research experiment?

"Affirmative. Clinicaltrials.gov reports that this medical trial is currently enrolling participants, which were posted on August 14th 2023 and last modified on the 18th of the same month. A total of 80 persons are needed to be recruited from one dedicated centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Support Through Remote Observation and Nutrition Guidance Program (STRONG-PCS)

2023. "Support Through Remote Observation and Nutrition Guidance Program (STRONG-PCS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06001268.