The STRONG Nutrition Support Study for People With Pancreatic Cancer (STRONG)
14 septembre 2026 mis à jour par: UNC Lineberger Comprehensive Cancer Center
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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
80
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Emma C Hume
- Numéro de téléphone: 9199664260
- E-mail: Emma.Hume@unc.edu
Lieux d'étude
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27599
- University of North Carolina at Chapel Hill, Department of Radiation Oncology
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Chercheur principal:
- Kea Turner, PhD, MPH, MA
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Contact:
- Emma C Hume
- Numéro de téléphone: 919-966-4260
- E-mail: Emma.Hume@unc.edu
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Arm 1: Remote Dietitian-Led Nutrition Counseling Plus STRONG
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.
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STRONG intervention app to support nutrition-related education, self-management, and engagement between counseling visits approximately 3 months.
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Comparateur actif: Arm 2: Remote Dietitian-Led Nutrition Counseling Plus Printed Nutrition Education Materials
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.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Recruitment Rate
Délai: Baseline
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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
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Baseline
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Retention Rate
Délai: Baseline
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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
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Baseline
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Study Assessment Completion
Délai: Up to 6 months
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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
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Up to 6 months
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Remote Nutrition Counseling Completion
Délai: Up to 6 months
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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
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Up to 6 months
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STRONG Engagement
Délai: Up to 6 months
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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
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Up to 6 months
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Food and Symptom Diary Completion
Délai: Up to 6 months
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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
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Intervention Fidelity
Délai: Up to 6 months
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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
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Reasons for Non-Participation or Attrition
Délai: Up to 6 months
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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.
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Up to 6 months
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Overall Satisfaction with STRONG
Délai: Up to 6 months
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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
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Up to 6 months
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Satisfaction with Intervention Components
Délai: Up to 6 months
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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
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Perceived Benefit
Délai: Up to 6 months
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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
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Changes in Nutritional Status
Délai: Baseline and up to 6 months
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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.
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Baseline and up to 6 months
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Changes in General Health-related Quality of Life
Délai: Baseline and up to 6 months
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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. |
Baseline and up to 6 months
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Appetite/Cachexia-Related Quality of Life
Délai: Baseline, up to 6 months
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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.
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Baseline, up to 6 months
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Hepatobiliary/Pancreatic Cancer-Related Quality of Life
Délai: Baseline, up to 6 months
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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.
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Baseline, up to 6 months
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Healthcare Utilization
Délai: Up to 6 months
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Healthcare Utilization: Number of emergency department visits during the study period, assessed by participant self-report and/or medical record abstraction, when available.
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Up to 6 months
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Treatment Delivery
Délai: Up to 6 months
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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.
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Up to 6 months
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Survival Outcomes
Délai: Up to 6 months
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Overall survival and progression-free survival, assessed using cancer registry data and/or medical record abstraction.
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Up to 6 months
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Caregiver burden will be assessed using the 12-item Short Form of the Zarit Burden Interview.
Délai: Up to 6 months
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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.
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Up to 6 months
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Change in caregiver quality of life
Délai: Baseline, up to 6 months
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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.
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Baseline, up to 6 months
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Change in caregiver distress
Délai: Baseline, up to 6 months
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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.
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Baseline, up to 6 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chercheur principal: Kea Turner, PhD, MPH, MA, UNC Lineberger Comprehensive Cancer Center
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 septembre 2026
Achèvement primaire (Estimé)
1 août 2029
Achèvement de l'étude (Estimé)
1 août 2029
Dates d'inscription aux études
Première soumission
8 septembre 2026
Première soumission répondant aux critères de contrôle qualité
14 septembre 2026
Première publication (Réel)
17 septembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
14 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système endocrinien
- Processus pathologiques
- Tumeurs par site
- Tumeurs
- Tumeurs du système digestif
- Maladies du système digestif
- Tumeurs des glandes endocrines
- Maladies pancréatiques
- Processus néoplasiques
- Conditions pathologiques, signes et symptômes
- Métastase néoplasmique
- Tumeurs pancréatiques
Autres numéros d'identification d'étude
- STRONG
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Researchers may request de-identified data 1 year after publication.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .