Effects of Neoadjuvant Prehabilitation on Post-Interventional Physical and Psychological Outcomes in Oncology Patients With Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prehabilitation, standard of care.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Solid Tumor. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
Detailed description
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.
Interventions
- Behavioral Prehabilitation
Targeted exercise and psychooncological program - Behavioral standard of care
Clinical routine as applied in Germany
Primary outcome measures
- Physical performance using the 6-Minute Walk Test [Time frame: From enrollment to 14 - 28 days after ablative intervention]
Secondary outcome measures (10)
- Muscle strength [Time frame: From enrollment to 14 - 28 days after ablative intervention]
- Handgrip strength [Time frame: From enrollment to 14 - 28 days after ablative intervention]
- Psychological distress [Time frame: From enrollment to 6 months after the ablative intervention]
- Anxiety [Time frame: From enrollment to 6 months after the ablative intervention]
- Depression [Time frame: From enrollment to 6 months after the ablative intervention]
- Emotional regulation [Time frame: From enrollment to 6 months after the ablative intervention]
- Emotion Beliefs [Time frame: From enrollment to 6 months after the ablative intervention]
- Health-related quality of life [Time frame: From enrollment to 6 months after the ablative intervention]
- Length of hospital stay [Time frame: From ablative intervention up to one month after ablative intervention]
- Infections [Time frame: From enrollment to 6 months after the ablative intervention]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Germany · 1 center
- University hospital Münster — Münster
Identifiers
NCT: NCT07464457 · 2025-1006-f-S