Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07464457

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Solid Tumor

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital Münster

Münster, North Rhine-Westphalia, 48149, Germany

Location status: Recruiting

Location contact

Mira Meyer-Ács

CONTACT

[email protected]

+49 251 83 49134

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prehabilitation

Behavioral

Targeted exercise and psychooncological program

Standard of Care

Behavioral

Clinical routine as applied in Germany

Primary outcomes

  1. Physical performance using the 6-Minute Walk Test

    Time frame: 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.

Secondary outcomes

  1. Muscle strength

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

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

  2. Handgrip strength

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

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

  3. Psychological distress

    Time frame: From enrollment to 6 months after the ablative intervention

    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.

  4. Anxiety

    Time frame: From enrollment to 6 months after the ablative intervention

    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).

  5. Depression

    Time frame: From enrollment to 6 months after the ablative intervention

    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).

  6. Emotional regulation

    Time frame: From enrollment to 6 months after the ablative intervention

    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.

  7. Emotion Beliefs

    Time frame: From enrollment to 6 months after the ablative intervention

    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.

  8. Health-related quality of life

    Time frame: From enrollment to 6 months after the ablative intervention

    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.

  9. Length of hospital stay

    Time frame: From ablative intervention up to one month after ablative intervention

    Length of hospital stay, defined as the number of inpatient days during ablative interventional treatment.

  10. Infections

    Time frame: From enrollment to 6 months after the ablative intervention

    Infections, with or without the need for inpatient treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Mira Meyer-Ács

CONTACT

[email protected]

+49 251 8349134

Sponsors and collaborators

Lead sponsor

Priv.-Doz. Dr. med. Philipp Lenz

Other

Registry information

Official study 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

Acronym: NEOPRO-SIT

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 11, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.