Effects of Neoadjuvant Prehabilitation on Post-Interventional Physical and Psychological Outcomes in Oncology Patients With Solid Tumors
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: Prehabilitation, standard of care.
- Кому может быть актуально
- Состояния в реестре: Breast Cancer, Solid Tumor. Базовые параметры: 18 лет — 65 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
- Германия
- 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
Effects of Neoadjuvant Prehabilitation on Post-Interventional Physical and Psychological Outcomes in Oncology Patients With Solid Tumors: A Prospective, Two-arm, Controlled, Monocentric Interventional Study
Обзор
The goal of NEOPRO-SIT is to establish and evaluate a neoadjuvant prehabilitation program comprised of targeted exercise therapy and structured psycho-oncological support in patients with solid tumors. The main question is: Will targeted exercise therapy and structured psycho-oncological support increase both physical and psychological capacity as well of quality of life compared to standard of care in a prehabilitation setting? Researchers will: compare a prehabilitation program to standard of care Participants will: receive either standard or care or a comprehensive prehabilitation program
Подробное описание
The project NEOPRO-SIT aims to establish and evaluate a neoadjuvant prehabilitation program comprised of targeted exercise therapy and structured psycho-oncological support in patients with solid tumors.
NEOPRO-SIT is a prospective, two-arm, controlled, single-center interventional study evaluating the effectiveness of neoadjuvant prehabilitation in patients with solid tumors. The study compares the standard of care with a structured, closely supervised prehabilitation program. A total of 125 patients will be enrolled in this study.
The NEOPRO-SIT project evaluates whether a structured, supervised prehabilitation program during neoadjuvant therapy provides additional physical and psychological benefits compared with a low-resource consultation-based approach. Despite the limitations of a sequential non-randomized design, the study aims to establish a feasible, standardized prehabilitation concept that could improve patient outcomes and support more efficient integration of supportive care into routine oncology.
Вмешательства
- Поведенческое Prehabilitation
Targeted exercise and psychooncological program - Поведенческое standard of care
Clinical routine as applied in Germany
Первичные конечные точки
- Physical performance using the 6-Minute Walk Test [Срок оценки: From enrollment to 14 - 28 days after ablative intervention]
Вторичные конечные точки (10)
- Muscle strength [Срок оценки: From enrollment to 14 - 28 days after ablative intervention]
- Handgrip strength [Срок оценки: From enrollment to 14 - 28 days after ablative intervention]
- Psychological distress [Срок оценки: From enrollment to 6 months after the ablative intervention]
- Anxiety [Срок оценки: From enrollment to 6 months after the ablative intervention]
- Depression [Срок оценки: From enrollment to 6 months after the ablative intervention]
- Emotional regulation [Срок оценки: From enrollment to 6 months after the ablative intervention]
- Emotion Beliefs [Срок оценки: From enrollment to 6 months after the ablative intervention]
- Health-related quality of life [Срок оценки: From enrollment to 6 months after the ablative intervention]
- Length of hospital stay [Срок оценки: From ablative intervention up to one month after ablative intervention]
- Infections [Срок оценки: From enrollment to 6 months after the ablative intervention]
Критерии участия
Критерии включения
- Patients with solid tumors (focus on breastcancer)
- Curative-intent multimodal treatment concept with local surgical or radiotherapeutic ablation
- Working age and > 18 years
- ECOG 0-2
- Sufficient language skills to understand questionnaires/training instructions
Критерии исключения
- Severe cardiac or pulmonary comorbidities that do not allow participation in the program
- Medical contraindications for physical activity
- Lack of patient capacity to consent
- Pregnancy/breastfeeding
- Acute infections/fever
- Participation in another clinical intervention study
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Последовательный дизайн
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
Германия · 1 центр
- University hospital Münster — Münster
Идентификаторы
NCT: NCT07464457 · 2025-1006-f-S