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

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

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Solid Tumor
• Intervention / Treatment: Behavioral: standard of care; Behavioral: Prehabilitation

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.

• Study Type: Interventional
• Enrollment (Estimated): 125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mira Meyer-Ács; Phone Number: +49 251 8349134; Email: mira.meyer-acs@ukmuenster.de

Study Locations

• Germany
  • North Rhine-Westphalia
    • Münster, North Rhine-Westphalia, Germany, 48149
      • Recruiting
      • University Hospital Münster
      • Contact: Mira Meyer-Ács; Phone Number: +49 251 83 49134; Email: mira.meyer-acs@ukmuenster.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control arm; Standard of care	Behavioral: standard of care; Clinical routine as applied in Germany
Experimental: Prehabilitation arm; Targeted execercise and psychooncological program	Behavioral: Prehabilitation; Targeted exercise and psychooncological program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to 14 - 28 days after ablative intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strength	Muscle strength, assessed using the 30-Second Chair Rise Test during and after ablative interventional therapy.	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.	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.	From enrollment to 6 months after the ablative intervention
Anxiety	Anxiety using the Generalized Anxiety Disorder Scale (GAD-7), a 7-item measure assessing symptoms of generalized anxiety over the past two weeks. Each item is rated from 0 ("not at all") to 3 ("nearly every day"), yielding a total score range of 0-21. Cut-offs are 5 (mild anxiety), 10 (moderate anxiety), and 15 (severe anxiety).	From enrollment to 6 months after the ablative intervention
Depression	Depression assessed using the Patient Health Questionnaire (PHQ-8), an 8-item instrument measuring depressive symptoms over the past two weeks. Items are rated from 0 ("not at all") to 3 ("nearly every day"), resulting in a total score range of 0-24. Cut-offs are 5 (mild depression), 10 (moderate depression), 15 (moderately severe depression), and 20 (severe depression).	From enrollment to 6 months after the ablative intervention
Emotional regulation	Emotional regulation assessed by the Emotion Regulation Questionnaire Short (ERQ-S), a shortened version of the ERQ assessing two emotion regulation strategies: cognitive reappraisal and expressive suppression. Items are rated on a 7-point Likert scale from 1 ("strongly disagree") to 7 ("strongly agree"). Subscale scores are calculated as mean values, with higher scores indicating greater use of the respective strategy.	From enrollment to 6 months after the ablative intervention
Emotion Beliefs	Beliefs about the usefulness and controllability of emotions assessed by the Emotion Beliefs Questionnaire (EBQ). Items are rated on a 7-point Likert scale (1 = "strongly disagree" to 7 = "strongly agree"). Subscale and total scores are calculated as mean values, with higher scores reflecting stronger maladaptive beliefs about emotions.	From enrollment to 6 months after the ablative intervention
Health-related quality of life	Health-related quality of life, assessed using the EORTC QLQ-C30 questionnaire. The EORTC QLQ-C30 is a validated, internationally used modular instrument for assessing quality of life in oncology patients. It comprises 30 items covering 15 symptom and functional domains.	From enrollment to 6 months after the ablative intervention
Length of hospital stay	Length of hospital stay, defined as the number of inpatient days during ablative interventional treatment.	From ablative intervention up to one month after ablative intervention
Infections	Infections, with or without the need for inpatient treatment	From enrollment to 6 months after the ablative intervention

Collaborators and Investigators

• Sponsor: Priv.-Doz. Dr. med. Philipp Lenz
• Investigators: Principal Investigator: Annalen Bleckmann, Univ.-Prof. Dr. med., University Hospital Münster; Principal Investigator: Philipp Lenz, Prof. Dr. med., University Hospital Münster; Principal Investigator: Markus Ramm, Dr. rer. nat., University Hospital Münster

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 11, 2026

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: oncology; prehabilitation; solid tumors; exercise therapy; psychoonlogic intervention
• Additional Relevant MeSH Terms: Neoplasms by Site; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Neoplasms; Breast Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Surgical Procedures, Operative; Quality of Health Care; Quality Indicators, Health Care; Patient Care; Health Services; Health Care Facilities Workforce and Services; Exercise; Perioperative Care; Standard of Care; Preoperative Exercise
• Other Study ID Numbers: 2025-1006-f-S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD are subject to data protection

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No