Nutrition Support for Pancreatic Cancer

(STRONG Trial)

EC
Overseen ByEmma C Hume
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: UNC Lineberger Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This single-center pilot randomized controlled trial evaluates the feasibility, acceptability, and preliminary effects of STRONG, a digital nutrition support app delivered alongside remote dietitian-led nutrition counseling, in adults with pancreatic ductal adenocarcinoma initiating systemic therapy and/or radiation therapy. Approximately 80 participants will be randomized 1:1 to receive nutrition counseling plus either the STRONG app or printed nutrition education materials. Outcomes include feasibility, acceptability, nutritional status, quality of life, healthcare utilization, treatment delivery, caregiver outcomes, and survival. Findings will inform the design of a future trial evaluating whether app-based, tailored nutrition support improves outcomes compared with traditional nutrition education.

Who Is on the Research Team?

KT

Kea Turner, PhD, MPH, MA

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with pancreatic ductal adenocarcinoma who are about to start chemotherapy or radiation. Participants should be able to use a smartphone app and take part in remote nutrition counseling.

Inclusion Criteria

I have started or will start systemic or radiation therapy within 30 days of joining the study.
Caregiver Participants: Identified by an enrolled patient participant as their primary caregiver or support person
Caregiver Participants: Able to speak and read English
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Exclusion Criteria

Patients Participants: Not community dwelling at the time of study enrollment, including individuals who are incarcerated, residing in a skilled nursing facility, long-term care facility, or other institutional setting where meals, nutrition management, or access to study procedures are primarily controlled by the institution
I do not have any condition that would prevent me from completing the study.
Caregiver Participants: Any condition or circumstance that, in the judgment of the investigator or designee, would make participation inappropriate or would interfere with completion of study procedures, such as advanced dementia or other severe cognitive impairment
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What Are the Treatments Tested in This Trial?

Interventions

  • Individualized remote dietitian
  • STRONG intervention App

Trial Overview

The study compares two ways of providing nutrition support: one group uses the STRONG nutrition app plus sessions with a dietitian, while the other gets printed nutrition materials and dietitian support. Participants are randomly assigned to each group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1: Remote Dietitian-Led Nutrition Counseling Plus STRONGExperimental Treatment1 Intervention
Group II: Arm 2: Remote Dietitian-Led Nutrition Counseling Plus Printed Nutrition Education MaterialsActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials
377
Recruited
95,900+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+