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The STRONG Nutrition Support Study for People With Pancreatic Cancer (STRONG)

14. září 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

80

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Spojené státy
    • North Carolina
      • Chapel Hill, North Carolina, Spojené státy, 27599
        • University of North Carolina at Chapel Hill, Department of Radiation Oncology
        • Vrchní vyšetřovatel:
          • Kea Turner, PhD, MPH, MA
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Jiný: STRONG intervention App
STRONG intervention app to support nutrition-related education, self-management, and engagement between counseling visits approximately 3 months.
Aktivní komparátor: 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.
Jiný: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Recruitment Rate
Časové okno: Baseline
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
Baseline
Retention Rate
Časové okno: Baseline
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
Baseline
Study Assessment Completion
Časové okno: Up to 6 months
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
Up to 6 months
Remote Nutrition Counseling Completion
Časové okno: Up to 6 months
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
Up to 6 months
STRONG Engagement
Časové okno: Up to 6 months
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
Up to 6 months
Food and Symptom Diary Completion
Časové okno: Up to 6 months

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
Intervention Fidelity
Časové okno: Up to 6 months

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
Reasons for Non-Participation or Attrition
Časové okno: Up to 6 months
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.
Up to 6 months
Overall Satisfaction with STRONG
Časové okno: Up to 6 months
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
Up to 6 months
Satisfaction with Intervention Components
Časové okno: Up to 6 months

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
Perceived Benefit
Časové okno: Up to 6 months

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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Changes in Nutritional Status
Časové okno: Baseline and up to 6 months
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.
Baseline and up to 6 months
Changes in General Health-related Quality of Life
Časové okno: Baseline and up to 6 months

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
Appetite/Cachexia-Related Quality of Life
Časové okno: Baseline, up to 6 months
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.
Baseline, up to 6 months
Hepatobiliary/Pancreatic Cancer-Related Quality of Life
Časové okno: 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.
Baseline, up to 6 months
Healthcare Utilization
Časové okno: Up to 6 months
Healthcare Utilization: Number of emergency department visits during the study period, assessed by participant self-report and/or medical record abstraction, when available.
Up to 6 months
Treatment Delivery
Časové okno: Up to 6 months
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.
Up to 6 months
Survival Outcomes
Časové okno: Up to 6 months
Overall survival and progression-free survival, assessed using cancer registry data and/or medical record abstraction.
Up to 6 months

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Caregiver burden will be assessed using the 12-item Short Form of the Zarit Burden Interview.
Časové okno: Up to 6 months
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.
Up to 6 months
Change in caregiver quality of life
Časové okno: Baseline, up to 6 months
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.
Baseline, up to 6 months
Change in caregiver distress
Časové okno: Baseline, up to 6 months
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.
Baseline, up to 6 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

UNC Lineberger Comprehensive Cancer Center

Spolupracovníci

United States Department of Defense

Vyšetřovatelé

  • Vrchní vyšetřovatel: Kea Turner, PhD, MPH, MA, UNC Lineberger Comprehensive Cancer Center

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. září 2026

Primární dokončení (Odhadovaný)

1. srpna 2029

Dokončení studie (Odhadovaný)

1. srpna 2029

Termíny zápisu do studia

První předloženo

8. září 2026

První předloženo, které splnilo kritéria kontroly kvality

14. září 2026

První zveřejněno (Aktuální)

17. září 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

17. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

14. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • STRONG

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

Researchers may request de-identified data 1 year after publication.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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