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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | Active Comparator | Standard of care |
|
| Prehabilitation arm | Experimental | Targeted execercise and psychooncological program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prehabilitation | Behavioral | Targeted exercise and psychooncological program |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mira Meyer-Ács | Contact | +49 251 8349134 | mira.meyer-acs@ukmuenster.de |
| Name | Affiliation | Role |
|---|---|---|
| Annalen Bleckmann, Univ.-Prof. Dr. med. | University hospital Münster | Principal Investigator |
| Philipp Lenz, Prof. Dr. med. | University hospital Münster | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital Münster | Recruiting | Münster | North Rhine-Westphalia | 48149 | Germany |
IPD are subject to data protection
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| standard of care |
| Behavioral |
Clinical routine as applied in Germany |
|
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 |
| Markus Ramm, Dr. rer. nat. |
| University hospital Münster |
| Principal Investigator |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000082622 | Preoperative Exercise |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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