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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Physical performance using the 6-Minute Walk Test
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with solid tumors (focus on breastcancer)
- •Curative-intent multimodal treatment concept with local surgical or radiotherapeutic ablation
- •Working age and > 18 years
- •Sufficient language skills to understand questionnaires/training instructions
排除标准
- •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
研究组 & 干预措施
Control arm
Standard of care
干预措施: standard of care (Behavioral)
Prehabilitation arm
Targeted execercise and psychooncological program
干预措施: Prehabilitation (Behavioral)
结局指标
主要结局
Physical performance using the 6-Minute Walk Test
时间窗: From enrollment to 14 - 28 days after ablative intervention
Physical performance at post-intervention (14-28 days after the ablative intervention), assessed using the 6-Minute Walk Test.
次要结局
- Muscle strength(From enrollment to 14 - 28 days after ablative intervention)
- Handgrip strength(From enrollment to 14 - 28 days after ablative intervention)
- Psychological distress(From enrollment to 6 months after the ablative intervention)
- Anxiety(From enrollment to 6 months after the ablative intervention)
- Depression(From enrollment to 6 months after the ablative intervention)
- Emotional regulation(From enrollment to 6 months after the ablative intervention)
- Emotion Beliefs(From enrollment to 6 months after the ablative intervention)
- Health-related quality of life(From enrollment to 6 months after the ablative intervention)
- Length of hospital stay(From ablative intervention up to one month after ablative intervention)
- Infections(From enrollment to 6 months after the ablative intervention)
研究者
Priv.-Doz. Dr. med. Philipp Lenz
CEO of the West German Cancer Center
University Hospital Muenster