The STRONG Nutrition Support Study for People With Pancreatic Cancer

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT07826780
Status
Not Yet Recruiting

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Conditions

  • Pancreas Cancer, Metastatic
  • Pancreas Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • STRONG intervention App — OTHER
    STRONG intervention app to support nutrition-related education, self-management, and engagement between counseling visits approximately 3 months.
  • individualized remote dietitian — OTHER
    individualized remote dietitian visits consisting of one initial visit and two remote follow-up visits over approximately 3 months. In addition, participants will receive printed nutrition education materials to support nutrition education and self-management during the intervention period.

Study Details

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.

Key Dates

First listed
Sep 17, 2026
Start date
Sep 30, 2026
Status verified
Sep 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Arm 1: Remote Dietitian-Led Nutrition Counseling Plus STRONG
    Participants randomized to the STRONG arm will receive individualized nutrition counseling delivered remotely by a registered dietitian, in addition to access to the STRONG intervention. The intervention will be delivered over approximately 3 months and will include one initial remote dietitian visit and two remote follow-up visits. Participants will use the STRONG app to support nutrition-related education, self-management, and engagement between counseling visits.
  • Active Comparator: Arm 2: Remote Dietitian-Led Nutrition Counseling Plus Printed Nutrition Education Materials
    Participants randomized to the comparison arm will receive the same schedule of individualized remote dietitian-led nutrition counseling as participants in the STRONG arm, consisting of one initial visit and two remote follow-up visits over approximately 3 months. In addition, participants will receive printed nutrition education materials to support nutrition education and self-management during the intervention period.

Primary Outcome Measure

Recruitment Rate [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel Hill, Department of Radiation OncologyChapel HillNorth Carolina27599
Emma C Hume
[email protected]
919-966-4260
Kea Turner, PhD, MPH, MA (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

By research site
University of North Carolina at Chapel Hill, Department of Radiation Oncology· Chapel Hill, NC

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