Breast Cancer, Solid Tumor
Conditions
Keywords
prehabilitation, exercise therapy, psychoonlogic intervention, oncology, solid tumors
Brief summary
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
BEHAVIORALPrehabilitation
Targeted exercise and psychooncological program
BEHAVIORALstandard of care
Clinical routine as applied in Germany
Sponsors
Priv.-Doz. Dr. med. Philipp Lenz
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical performance using the 6-Minute Walk Test | 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
| Measure | Time frame | Description |
|---|---|---|
| Muscle strength | 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. |
| Handgrip strength | From enrollment to 14 - 28 days after ablative intervention | Muscle strength, assessed using handgrip strength measured by dynamometry during and after ablative interventional therapy. |
| Psychological distress | 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. |
| Anxiety | 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). |
| Depression | 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). |
| Emotional regulation | 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. |
| Emotion Beliefs | 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. |
| Health-related quality of life | 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. |
| Length of hospital stay | 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. |
| Infections | From enrollment to 6 months after the ablative intervention | Infections, with or without the need for inpatient treatment |
Countries
Germany
Contacts
CONTACTMira Meyer-Ács
PRINCIPAL_INVESTIGATORAnnalen Bleckmann, Univ.-Prof. Dr. med.
University hospital Münster
PRINCIPAL_INVESTIGATORPhilipp Lenz, Prof. Dr. med.
University hospital Münster
PRINCIPAL_INVESTIGATORMarkus Ramm, Dr. rer. nat.
University hospital Münster
Outcome results
None listed