The STRONG Nutrition Support Study for People With Pancreatic Cancer

N/ANot Yet RecruitingNCT07826780

UNC Lineberger Comprehensive Cancer Center80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Pancreas Cancer, Metastatic Pancreas Carcinoma

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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

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

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

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

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

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Up to 6 months

Secondary Outcomes

Changes in Nutritional Status

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.

Time frame: Baseline and up to 6 months

Changes in General Health-related Quality of Life

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.

Time frame: Baseline and up to 6 months

Appetite/Cachexia-Related Quality of Life

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.

Time frame: Baseline, up to 6 months

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.

The STRONG Nutrition Support Study for People With Pancreatic Cancer

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts