The STRONG Nutrition Support Study for People With Pancreatic Cancer

Brief summary public domain (ClinicalTrials.gov)

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.

Intervention public domain (ClinicalTrials.gov)

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

Intervention public domain (ClinicalTrials.gov)

Other: individualized remote dietitian. 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 public domain (ClinicalTrials.gov)

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.

Arm public domain (ClinicalTrials.gov)

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.

Primary outcome public domain (ClinicalTrials.gov)

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 Time frame: Baseline.

Primary outcome public domain (ClinicalTrials.gov)

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 Time frame: Baseline.

Primary outcome public domain (ClinicalTrials.gov)

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 Time frame: Up to 6 months.

Primary outcome public domain (ClinicalTrials.gov)

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 Time frame: Up to 6 months.

Primary outcome public domain (ClinicalTrials.gov)

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 Time frame: Up to 6 months.

Secondary outcome public domain (ClinicalTrials.gov)

Changes in Nutritional Status. Time frame: Baseline and up to 6 months.

Secondary outcome public domain (ClinicalTrials.gov)

Changes in General Health-related Quality of Life. Time frame: Baseline and up to 6 months.

Secondary outcome public domain (ClinicalTrials.gov)

Appetite/Cachexia-Related Quality of Life. Time frame: Baseline, up to 6 months.

Secondary outcome public domain (ClinicalTrials.gov)

Hepatobiliary/Pancreatic Cancer-Related Quality of Life. Time frame: Baseline, up to 6 months.

Secondary outcome public domain (ClinicalTrials.gov)

Healthcare Utilization. Time frame: Up to 6 months.

Secondary outcome public domain (ClinicalTrials.gov)

Treatment Delivery. Time frame: Up to 6 months.

Eligibility public domain (ClinicalTrials.gov)

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.

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 80 participants (estimated).