The STRONG Nutrition Support Study for People With Pancreatic Cancer

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

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

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

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

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

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

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

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.

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

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

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

The Patient-Generated Subjective Global Assessment (PG-SGA) Short Form is a nutrition screening tool that assesses recent weight change, food intake, nutrition-impact symptoms, and functional status. Scores range from 0 to 36, with higher scores indicating greater nutritional risk and need for intervention: 0-1 suggests no immediate intervention, 2-3 indicates possible need for patient education or symptom management, 4-8 indicates a need for intervention by a dietitian or nutrition professional, and ≥9 indicates a critical need for nutrition intervention and/or symptom management.

General health-related quality of life was assessed using Change in Functional Assessment of Cancer Therapy-General (FACT-G) score.

The Functional Assessment of Cancer Therapy-General (FACT-G) is a validated 27-item questionnaire used to assess health-related quality of life (HRQoL) in people with cancer. It evaluates four domains: Physical Well-Being (0-28), Social/Family Well-Being (0-28), Emotional Well-Being (0-24), and Functional Well-Being (0-28), giving a total score ranging from 0 to 108. Each item is rated on a 5-point Likert scale from 0 ("Not at all") to 4 ("Very much"). Higher FACT-G scores indicate better quality of life, while lower scores indicate greater impairment or burden.

Change in Functional Assessment of Anorexia/Cachexia Therapy (FAACT) subscale score from baseline to 3 months and from baseline to 6 months. The Functional Assessment of Anorexia/Cachexia Therapy (FAACT) is a patient-reported measure designed to assess quality of life and symptoms associated with cancer-related anorexia/cachexia. It combines the FACT-G questionnaire with an additional 12-item Anorexia/Cachexia Subscale (A/CS), for a total of 39 items. Each item is scored from 0 ("Not at all") to 4 ("Very much"), with negatively worded items reverse-scored. The FAACT total score ranges from 0-156, and higher scores generally indicate better quality of life and fewer anorexia/cachexia-related concerns. Changes in FAACT scores over time can therefore be used to evaluate whether a patient's symptoms and overall quality of life have improved or worsened.

Change in Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) score from baseline to 3 months and from baseline to 6 months. The Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) is a 44-item patient-reported questionnaire assessing health-related quality of life in patients with hepatobiliary cancer. It combines the 27-item FACT-G with a 17-item Hepatobiliary Cancer Subscale (HCS). Each item is scored from 0 ("Not at all") to 4 ("Very much"), with negatively worded items reverse-scored. The total FACT-Hep score ranges from 0 to 176, with higher scores indicating better quality of life and lower scores indicating greater symptom burden or impairment.

Healthcare Utilization: Number of emergency department visits during the study period, assessed by participant self-report and/or medical record abstraction, when available.

Treatment Delivery will be defined based on records related to treatment delay, dose reduction, and treatment discontinuation during the study period, assessed by medical record abstraction.

Overall survival and progression-free survival, assessed using cancer registry data and/or medical record abstraction.

Caregiver burden will be assessed using the 12-item Short Form of the Zarit Burden Interview. The outcome will be the change in ZBI score from baseline to 3 months and from baseline to 6 months. The Zarit Burden Interview (ZBI) 12-item Short Form is a self-report measure of caregiver burden. It assesses how caregiving affects the caregiver's emotional, social, physical, and financial well-being. The total score ranges from 0 to 48, with higher scores indicating greater caregiver burden.

Caregiver quality of life will be assessed using the Caregiver Quality of Life Index-Cancer (CQOLC), a self-report instrument designed to assess the quality of life of individuals providing care to patients with cancer. The CQOLC evaluates multiple domains of caregiver quality of life, including emotional distress, burden, positive adaptation, and disruption of daily activities. The total score ranges from 0-140, with higher scores indicating better caregiver quality of life[M.

Caregiver distress will be assessed using the caregiver-specific version of the National Comprehensive Cancer Network (NCCN) Distress Thermometer. The Distress Thermometer is a self-report measure of overall distress rated on a 0-to-10 scale, with 0 indicating no distress and 10 indicating extreme distress. The caregiver-specific version includes additional problem areas relevant to caregiving, such as assisting with symptom management and providing emotional support. Higher scores indicates greater distress.