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Supportive Care + Nutritional Counseling for Pancreatic Cancer

N/A

Waitlist Available

Led By Pamela 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

≥18 years old

Able to speak and read English or Spanish

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial assesses a new program that provides nutrition and supportive care to pancreatic cancer patients undergoing chemotherapy.

Who is the study for?

Adults over 18 with newly diagnosed or recurrent pancreatic cancer who are starting chemotherapy can join. They must be able to consent, speak English or Spanish, and not have serious psychiatric issues, another GI cancer treatment, poor physical function (ECOG status >2), recent chemo for recurrence, or use tube feeding.Check my eligibility

What is being tested?

The STRONG program is being tested for its effectiveness in providing nutritional guidance and supportive care using tools like Fitbit data collection and surveys (Fact G Survey, GAD-7, PHQ-9) to improve the well-being of patients undergoing chemotherapy for pancreatic cancer.See study design

What are the potential side effects?

There may not be direct side effects from the STRONG program itself as it involves non-invasive support measures. However, participants may experience emotional discomfort when discussing their health condition during counseling sessions.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I can speak and read English or Spanish.

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I have been recently diagnosed with advanced or recurrent pancreatic cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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 for the Mobile Application - Usability

Recruitment Rate - Feasibility

Secondary outcome measures

Participant Compliance with Dietary Log - Intervention Adherence

Participant Compliance with Dietician Visits - Intervention Adherence

Participant Compliance with Palliative Care Visits - Intervention Adherence

Trial Design

1Treatment groups

Experimental Treatment

Group I: Nutritional SupportExperimental Treatment5 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 data with a dietician

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

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

542 Previous Clinical Trials

135,442 Total Patients Enrolled

Canopy Cancer CollectiveUNKNOWN

1 Previous Clinical Trials

20 Total Patients Enrolled

Pamela Hodul, MDPrincipal InvestigatorMoffitt Cancer Center

4 Previous Clinical Trials

163 Total Patients Enrolled

Media Library

Nutrition Counseling Clinical Trial Eligibility Overview. Trial Name: NCT05438927 — N/A

Pancreatic Cancer Research Study Groups: Nutritional Support

Pancreatic Cancer Clinical Trial 2023: Nutrition Counseling Highlights & Side Effects. Trial Name: NCT05438927 — N/A

Nutrition Counseling 2023 Treatment Timeline for Medical Study. Trial Name: NCT05438927 — N/A

Frequently Asked Questions

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

Is this research endeavor currently recruiting participants?

"Per the information on clinicaltrials.gov, this trial is currently in need of volunteers and has been since June 22nd 2022. The post was most recently updated October 27th 2022."

Answered by AI

How many participants have been enrolled in this research endeavor?

"Indeed, the information presented on clinicaltrials.gov confirms that this medical experiment is presently recruiting for participants. This trial was first published on June 22nd 2022 and has been updated as recently as October 27th of the same year; 50 patients are sought from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Early Supportive Care and Nutritional Support in Adults With Pancreatic Cancer

2022. "Early Supportive Care and Nutritional Support in Adults With Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05438927.