Effects of Neoadjuvant Prehabilitation on Post-Interventional Physical and Psychological Outcomes in Oncology Patients With Solid Tumors

Priv.-Doz. Dr. med. Philipp Lenz125 enrolled

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

125

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Physical performance using the 6-Minute Walk Test

Physical performance at post-intervention (14-28 days after the ablative intervention), assessed using the 6-Minute Walk Test.

Time frame: From enrollment to 14 - 28 days after ablative intervention

Secondary Outcomes

Muscle strength

Muscle strength, assessed using the 30-Second Chair Rise Test during and after ablative interventional therapy.

Time frame: From enrollment to 14 - 28 days after ablative intervention

Handgrip strength

Muscle strength, assessed using handgrip strength measured by dynamometry during and after ablative interventional therapy.

Time frame: From enrollment to 14 - 28 days after ablative intervention

Psychological distress

Psychological distress measured using the NCCN Distress Thermometer, a single-item visual analog scale ranging from 0 ("no distress") to 10 ("extreme distress"). A score of ≥4 is commonly used as a threshold for clinically significant distress requiring further evaluation.