The STRONG Nutrition Support Study for People With Pancreatic Cancer

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.

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.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

Patients Participants

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Inclusion Criteria:

* 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.

Exclusion Criteria:

• 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.

Sites (1)

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