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Behavioral Intervention

Nutrition Coaching for Pancreatic Cancer

N/A

Recruiting

Led By Sylvia Crowder, 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 months

Awards & highlights

Study Summary

This trial will test a food/nutrition coaching program to help cancer patients during chemotherapy.

Who is the study for?

This trial is for adults over 18 with newly diagnosed, non-metastatic pancreatic cancer who are about to start chemotherapy and can eat by mouth. They must be able to understand English and give verbal consent. People with serious mental disorders or those on tube feeding, pregnant women, or patients with bowel obstruction risks cannot join.Check my eligibility

What is being tested?

The study tests a remote nutrition coaching program during the first 12 weeks of chemotherapy for pancreatic cancer. It includes dietary assessments using questionnaires, educational materials on nutrition, personalized coaching sessions, and follow-up surveys to measure cognitive function and quality of life.See study design

What are the potential side effects?

Since this trial focuses on nutritional support rather than medication, there may not be direct side effects like those seen in drug trials. However, participants might experience discomfort from frequent monitoring or stress from adherence to the intervention's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 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

Adherence - Feasibility

Recruitment Rate -Feasibility

Retention Rate - Feasibility

Secondary outcome measures

Participant Satisfaction with Overall Program- Acceptability

Participant intent to continue using skills- Acceptability

Participant perception of utility of knowledge gained - Acceptability

Other outcome measures

Treatment Effect - Quality of Life

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment ResponseExperimental Treatment6 Interventions

Participants randomized to the MONITOR arm will be provided dietary coaching biweekly to discuss nutrition concerns, anti-inflammatory diet compliance, and set SMART goals based on their most recent Vioscreen food frequency questionnaires.

Group II: Standard Usual CareActive Control5 Interventions

Standard Usual Care participants will receive usual nutrition care received in the Moffitt Cancer Center pancreatic clinic, in addition to handouts on diet.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

543 Previous Clinical Trials

135,442 Total Patients Enrolled

Sylvia Crowder, PhDPrincipal InvestigatorMoffitt Cancer Center

1 Previous Clinical Trials

40 Total Patients Enrolled

Pamela Hodul, MDPrincipal InvestigatorMoffitt Cancer Center

4 Previous Clinical Trials

173 Total Patients Enrolled

Frequently Asked Questions

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

Are there any open slots to join this experiment?

"As indicated on clinicaltrials.gov, this experiment is welcoming new participants. It was introduced to the public on September 8th 2023 and revised most recently on September 15th of the same year."

Answered by AI

What is the current capacity for enrolment in this clinical experiment?

"Yes, the evidence on clinicaltrials.gov confirms that as of 9/15/2023, this medical research is still looking for volunteers. The study was first advertised on September 8th and requires 40 participants from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The MONITOR Study: Remote Monitoring Of a Nutrition Intervention To Optimize Treatment Response

2023. "The MONITOR Study: Remote Monitoring Of a Nutrition Intervention To Optimize Treatment Response". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06050395.