Prehab for Pancreatic Cancer Surgery
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: Multimodal Prehabilitation.
- Кому может быть актуально
- Состояния в реестре: Pancreatic Cancer, Adult, Prehabilitation. 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 →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Multimodal Prehabilitation Prior to Pancreatic Cancer Surgery: A Pilot Study
Обзор
The goal of this clinical study is to test whether a structured prehabilitation program can be successfully used by adults with pancreatic cancer who are receiving chemotherapy before planned surgery. Prehabilitation is a program designed to improve a person's physical fitness, nutrition, and symptom control before surgery. The study's main hypothesis is that patients with pancreatic cancer can take part in and adhere to a multimodal prehabilitation program during chemotherapy, and that doing so may improve physical function, patient experience, and early recovery after surgery.
Подробное описание
This is a single-center, prospective pilot study designed to evaluate the implementation of a standardized, multimodal prehabilitation program delivered during neoadjuvant chemotherapy prior to pancreatic cancer surgery. The intervention is integrated into routine preoperative care and includes coordinated physical activity, nutritional optimization, and supportive care components delivered throughout the neoadjuvant treatment period. Assessments are performed at baseline, after completion of the prehabilitation period and before surgery, and approximately one month after surgery to characterize participation, intervention delivery, and perioperative changes in functional and clinical measures.
Data collection includes standardized functional fitness assessments, patient-reported surveys, and abstraction of perioperative clinical data from the electronic medical record. Analyses are descriptive and exploratory, reflecting the pilot nature of the study, and are intended to characterize feasibility, adherence, and variability of measured outcomes rather than to test efficacy. Findings from this study will be used to refine intervention delivery, identify logistical and patient-level barriers, and inform the design of future larger-scale studies evaluating prehabilitation in pancreatic cancer surgery.
Вмешательства
- Поведенческое Multimodal Prehabilitation
Participants will receive a structured, multimodal prehabilitation program delivered during neoadjuvant chemotherapy prior to planned pancreatic cancer surgery. The program integrates supervised, individualized exercise training, nutritional assessment and counseling with recommended preoperative immunonutrition, and supportive care focused on symptom management and functional support. Prehabilitation is delivered as an integrated component of preoperative care and continues through completion o
Первичные конечные точки
- Feasibility of prehabilitation program delivery [Срок оценки: From enrollment through completion of neoadjuvant therapy (approximately 3-6 months)]
- Adherence to prehabilitation components [Срок оценки: From enrollment through preoperative assessment (approximately 3-6 months)]
Вторичные конечные точки (8)
- Change in 6-minute walk distance [Срок оценки: Baseline enrollment (pre-prehabilitation) to preoperative assessment (after completion of prehabilitation) up to 6 months after enrollment.]
- Change in Fried Frailty phenotype between enrollment and pre-operative evaluation [Срок оценки: Enrollment to preoperative assessment (up to 6 months after enrollment)]
- Change in nutritional status using the Patient Generated-Subjective Global Assessment (PG-SGA) [Срок оценки: Baseline, preoperative assessment, postoperative follow up (up to 1 year after enrollment)]
- Change in body mass index (BMI) [Срок оценки: Enrollment, preoperative assessment, through postoperative follow up, up to 1 year after enrollment]
- Change in physical functioning measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10a [Срок оценки: Baseline, preoperative assessment, postoperative follow up (up to 1 year after enrollment)]
- Change in health related quality of life measured by change in Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) score [Срок оценки: Baseline, preoperative assessment, postoperative follow up (up to 1 year after enrollment)]
- Postoperative complications measured using Clavien-Dindo classification [Срок оценки: Up to 30 days after surgery (up to 1 year after enrollment)]
- Postoperative hospital length of stay [Срок оценки: Up to 90 days postoperative (up to 14 months after enrollment)]
Критерии участия
Критерии включения
- Age ≥ 18 years
- Diagnosis of pancreatic ductal adenocarcinoma (PDAC)
- Planned neoadjuvant chemotherapy prior to planned surgical resection
- Medically stable and cleared to participate in physical activity/exercise programming
- Able to provide informed consent
- Ability to read, write and understand English
Критерии исключения
- Age <18 years
- Pregnant
- Prisoner
- Severe cognitive impairment that precludes informed consent or participation
- Contraindications to physical activity, including unstable cardiac disease, severe pulmonary disease, or recent myocardial infarction
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 1 центр
- UMass Memorial Medical Center — Worester
Идентификаторы
NCT: NCT07478185 · STUDY00002524