Идёт набор NCT06497569
Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Dietitian Consultation, Survey, Fitbit Data Collection, Referral to Dietitian.
- Кому может быть актуально
- Состояния в реестре: GastroEsophageal Cancer. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer (STRONG-GEC)
Обзор
The purpose of this study is to determine how the STRONG intervention compares with usual care for reducing malnutrition among gastroesophageal cancer patients.
Вмешательства
- Поведенческое Dietitian Consultation
Participants will meet with a dietitian who will provide individualized nutrition counseling and dietary goals for calorie and protein intake. Bi-weekly, 30-minute dietitian telehealth visits will be conducted via ZOOM videoconferencing at the pre-intervention baseline visit, monthly during the intervention period (up to 90 days) and at the 4 and 6 month timepoints post-intervention. - Поведенческое Survey
Surveys will be conducted using the PG-SGA short form19-21 and a brief symptom assessment tool that captures additional nutrition-impact symptoms not captured by the PG-SGA (e.g., swallowing difficulty) measured by the FACT Esophageal and Gastric Cancer scales and the FAACT anorexia/cachexia scales 22,23 through REDCap. Surveys are completed at the pre-intervention baseline visit and monthly during the intervention period prior to the dietitian visits (up to 90 days), and at the 4 and 6 month t - Поведенческое Fitbit Data Collection
Participants will log food intake while sharing their data with a dietitian during the 30-minute dietitian telehealth visits at the pre-intervention baseline visit, monthly during the intervention period (up to 90 days) and at the 4 and 6 month timepoints post-intervention. - Поведенческое Referral to Dietitian
Usual Care condition referral to a dietitian based on physician discretion. - Поведенческое Social Determinants of Health Survey (SDOH)
Participants will complete a SDOH Survey that captures individual-level factors (insurance type, preferred language, educational attainment, annual household income, digital health literacy, financial toxicity, and self-reported barriers to care \[e.g., transportation\]) and structural-level factors (neighborhood disadvantage, rural residence). Digital health literacy will be measured using the validated eHEALS scale, an 8-item measure assessing confidence with finding, evaluating, and applying
Первичные конечные точки
- Recruitment Rate- Feasibility [Срок оценки: Up to 48 Months]
- Retention Rate- Feasibility [Срок оценки: Up to 90 Days]
- Patient-reported outcome completion-Feasibility [Срок оценки: Up to 6 Months]
- Food Log Data Collection-Feasibility [Срок оценки: Up to 6 Months]
- Adherence to Dietitian Visits- Feasibility [Срок оценки: Up to 6 Months]
- Fidelity to Study Protocol- Feasibility [Срок оценки: Up to 6 Months]
- Patient Rating of MyPlate app-Feasibility [Срок оценки: Up to 6 Months]
- Participant Satisfaction- Acceptability [Срок оценки: Up to 6 Months]
Вторичные конечные точки (7)
- Malnutrition -Nutritional Status [Срок оценки: Baseline, 3 Months, 6 Months]
- Malnutrition-Significant weight loss [Срок оценки: Baseline, 3 Months, 6 Months]
- Malnutrition - Low BMI [Срок оценки: Baseline, 3 Months, 6 Months]
- Malnutrition - Low Skeletal Muscle Mass [Срок оценки: Baseline, 3 Months, 6 Months]
- Quality of Life Questionnaires [Срок оценки: Baseline, 3 Months, 6 Months]
- Treatment Adherence [Срок оценки: Baseline, 3 Months, 6 Months]
- Progression Free Survival (PFS) [Срок оценки: Up to 48 Months]
Критерии участия
Критерии включения
- Participants must be 18 years of age or older
- Participants must have locally advanced or metastatic gastroesophageal cancer (GEC)
- Participants must plan to initiate chemotherapy and/or radiation therapy with a plan to have surgery or definitive treatment follow up at Moffitt
- Participants must be able to speak and read Spanish and/or English
- Participants must be able to provide informed consent
Критерии исключения
- Participants have a documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g. severe dementia)
- Use of feeding tubes at the time of study enrollment
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 2 центра
- Moffitt Cancer Center — Tampa
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill
Публикации
- Turner K, Somasundaram A, Small BJ, Milano J, Santiago C, Sprow O, Hume E, Khajoueinejad N, McKinnie N, Pereira AL, Sinnamon A, Permuth JB, Tabriz AA, Pimiento JM. A patient-mediated implementation strategy to improve nutrition care delivery for esophageal and gastric cancer: a study protocol for a pilot randomized controlled trial. J Health Popul Nutr. 2025 Dec 28;45(1):37. doi: 10.1186/s41043-02 PMID 41457289
Идентификаторы
NCT: NCT06497569 · MCC-23230