The STRONG Nutrition Support Study for People With Pancreatic Cancer

NCT07826780 | Not Yet Recruiting

• 1 other identifier: STRONG
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreas Carcinoma; Pancreas Cancer, Metastatic

Keywords

diet; chemotherapy; systemic therapy; radiotherapy; nutrition app

Outcome Measures

Primary Outcomes (11)

• Recruitment Rate

  Proportion of eligible patient participants who provide informed consent and enroll in the study. The feasibility benchmark is ≥50%. Recruitment Rate (%) = (Number of eligible patients who consent and enroll ÷ Number of eligible patients approached) × 100

  Baseline

• Retention Rate

  Proportion of enrolled patient participants who remain in the study through completion of the 3-month intervention period. The feasibility benchmark is ≥85%. Retention Rate (%) = (Number of enrolled participants who complete the 3-month intervention period ÷ Total number of enrolled participants) × 100

  Baseline

• Study Assessment Completion

  The proportion of enrolled participants who complete at least 2 of the 3 scheduled study assessments during the study period. Assessment Completion Rate (%) = (Number of enrolled participants who complete ≥2 of 3 assessments ÷ Total number of enrolled participants) × 100

  Up to 6 months

• Remote Nutrition Counseling Completion

  Proportion of randomized patient participants who complete at least 2 of the 3 planned remote dietitian counseling visits during the 3-month intervention period. The feasibility benchmark is ≥70%. Counseling Completion Rate (%) = (Number of randomized participants who complete ≥2 of 3 counseling visits ÷ Total number of randomized participants) × 100

  Up to 6 months

• STRONG Engagement

  The proportion of STRONG-arm participants who demonstrate sustained engagement with the STRONG intervention by accessing STRONG at least once per week during at least 6 of the 12 intervention weeks. STRONG Engagement Rate (%) = (Number of STRONG-arm participants who access STRONG ≥1 time/week during ≥6 of 12 intervention weeks ÷ Total number of STRONG-arm participants) × 100

  Up to 6 months

• Food and Symptom Diary Completion

  Among STRONG-arm patient participants, the proportion who complete the food and symptom diary on at least 2 of the 3 days preceding each of the three planned dietitian counseling visits. The feasibility benchmark is ≥70%. Diary Completion Rate (%) = (Number of STRONG-arm participants who complete the diary on ≥2 of 3 days before all 3 counseling visits ÷ Total number of STRONG-arm participants) × 100

  Up to 6 months

• Intervention Fidelity

  Proportion of completed dietitian counseling visits in which all required counseling elements outlined in the study counseling checklist were documented as delivered. The fidelity benchmark is ≥80%. Intervention Fidelity (%) = (Number of completed counseling visits with documentation that all required checklist elements were delivered ÷ Total number of completed counseling visits) × 100

  Up to 6 months

• Reasons for Non-Participation or Attrition

  Reasons for declining participation, inability to enroll, withdrawal, missed counseling visits, incomplete diary use, or incomplete study assessments will be documented and summarized descriptively when available.

  Up to 6 months

• Overall Satisfaction with STRONG

  Proportion of STRONG-arm patient participants who complete the 3-month survey and report satisfaction with STRONG. The acceptability benchmark is ≥80%. Satisfaction Rate (%) = (Number of STRONG-arm participants who complete the 3-month survey and report satisfaction with STRONG ÷ Number of STRONG-arm participants who complete the 3-month survey) × 100

  Up to 6 months

• Satisfaction with Intervention Components

  Among STRONG-arm patient participants, the proportion who report satisfaction with each of the three intervention components: remote nutrition counseling, STRONG, and the food and symptom diary. Component Satisfaction Rate (%) = (Number of STRONG-arm participants who report satisfaction with the component ÷ Number of STRONG-arm participants who complete the relevant satisfaction item) × 100

  Up to 6 months

• Perceived Benefit

  Proportion of STRONG-arm patient participants who report that STRONG was beneficial or helpful for managing nutrition concerns during pancreatic cancer treatment. Perceived Benefit Rate (%) = (Number of STRONG-arm participants who report that STRONG was beneficial or helpful ÷ Number of STRONG-arm participants who complete the relevant survey item) × 100

  Up to 6 months

Secondary Outcomes (7)

• Changes in Nutritional Status

  Baseline and up to 6 months

• Changes in General Health-related Quality of Life

  Baseline and up to 6 months

• Appetite/Cachexia-Related Quality of Life

  Baseline, up to 6 months

• Hepatobiliary/Pancreatic Cancer-Related Quality of Life

  Baseline, up to 6 months

• Healthcare Utilization

  Up to 6 months

Other Outcomes (3)

• Caregiver burden will be assessed using the 12-item Short Form of the Zarit Burden Interview.

  Up to 6 months

• Change in caregiver quality of life

  Baseline, up to 6 months

• Change in caregiver distress

  Baseline, up to 6 months

Study Arms (2)

Arm 1: Remote Dietitian-Led Nutrition Counseling Plus STRONG

EXPERIMENTAL

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.

Other: STRONG intervention App

Arm 2: Remote Dietitian-Led Nutrition Counseling Plus Printed Nutrition Education Materials

ACTIVE COMPARATOR

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.

Other: individualized remote dietitian

Interventions

STRONG intervention App OTHER

STRONG intervention app to support nutrition-related education, self-management, and engagement between counseling visits approximately 3 months.

Arm 1: Remote Dietitian-Led Nutrition Counseling Plus STRONG

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.

Arm 2: Remote Dietitian-Led Nutrition Counseling Plus Printed Nutrition Education Materials

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
• Subjects is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
• Age ≥ 18 years at the time of consent.
• Diagnosis of pancreatic ductal adenocarcinoma
• Has initiated or scheduled to initiate systemic therapy and/or radiation therapy within 30 days of study enrollment
• Able to speak and read English

You may not qualify if:

• Enrolled in hospice care or has a plan for hospice enrollment at the time of study enrollment
• 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
• Unable to consume food or beverages orally at the time of consent, including individuals who are fully dependent on total parenteral nutrition or who have complete malignant bowel obstruction or severe gastric outlet obstruction that prevents meaningful oral intake or makes oral nutrition unsafe.
• Any condition or circumstance that, in the judgment of the investigator or designee, such as a patient's oncologist, would make study participation inappropriate or would interfere with the participant's ability to complete study procedures, such as advanced dementia or other severe cognitive impairment.
• Caregiver Participants
• Age ≥18 years at the time of consent.
• Identified by an enrolled patient participant as their primary caregiver or support person.
• Able to speak and read English
• Able to provide informed consent.
• Willing and able to complete caregiver study procedures, including baseline and follow-up questionnaires and, if selected and interested, an optional exit interview.
• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill, Department of Radiation Oncology

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kea Turner, PhD, MPH, MA

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma C Hume

CONTACT

9199664260; Emma.Hume@unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 17, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)