Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:03 AM
Study NCT ID:
NCT07464457
Status:
RECRUITING
Last Update Posted:
2026-03-11
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Neoadjuvant Prehabilitation on Post-Interventional Physical and Psychological Outcomes in Oncology Patients With Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082622', 'term': 'Preoperative Exercise'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019990', 'term': 'Perioperative Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2029-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-05', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-03-05', 'lastUpdatePostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical performance using the 6-Minute Walk Test', 'timeFrame': 'From enrollment to 14 - 28 days after ablative intervention', 'description': 'Physical performance at post-intervention (14-28 days after the ablative intervention), assessed using the 6-Minute Walk Test.'}], 'secondaryOutcomes': [{'measure': 'Muscle strength', 'timeFrame': 'From enrollment to 14 - 28 days after ablative intervention', 'description': 'Muscle strength, assessed using the 30-Second Chair Rise Test during and after ablative interventional therapy.'}, {'measure': 'Handgrip strength', 'timeFrame': 'From enrollment to 14 - 28 days after ablative intervention', 'description': 'Muscle strength, assessed using handgrip strength measured by dynamometry during and after ablative interventional therapy.'}, {'measure': 'Psychological distress', 'timeFrame': 'From enrollment to 6 months after the ablative intervention', 'description': '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.'}, {'measure': 'Anxiety', 'timeFrame': 'From enrollment to 6 months after the ablative intervention', 'description': '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).'}, {'measure': 'Depression', 'timeFrame': 'From enrollment to 6 months after the ablative intervention', 'description': '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).'}, {'measure': 'Emotional regulation', 'timeFrame': 'From enrollment to 6 months after the ablative intervention', 'description': '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.'}, {'measure': 'Emotion Beliefs', 'timeFrame': 'From enrollment to 6 months after the ablative intervention', 'description': '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.'}, {'measure': 'Health-related quality of life', 'timeFrame': 'From enrollment to 6 months after the ablative intervention', 'description': '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.'}, {'measure': 'Length of hospital stay', 'timeFrame': 'From ablative intervention up to one month after ablative intervention', 'description': 'Length of hospital stay, defined as the number of inpatient days during ablative interventional treatment.'}, {'measure': 'Infections', 'timeFrame': 'From enrollment to 6 months after the ablative intervention', 'description': 'Infections, with or without the need for inpatient treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prehabilitation', 'exercise therapy', 'psychoonlogic intervention', 'oncology', 'solid tumors'], 'conditions': ['Breast Cancer', 'Solid Tumor']}, 'descriptionModule': {'briefSummary': '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.\n\nThe main question is:\n\nWill 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?\n\nResearchers will:\n\ncompare a prehabilitation program to standard of care\n\nParticipants will:\n\nreceive either standard or care or a comprehensive prehabilitation program', 'detailedDescription': '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.\n\nNEOPRO-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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with solid tumors (focus on breastcancer)\n* Curative-intent multimodal treatment concept with local surgical or radiotherapeutic ablation\n* Working age and \\> 18 years\n* ECOG 0-2\n* Sufficient language skills to understand questionnaires/training instructions\n\nExclusion Criteria:\n\n* Severe cardiac or pulmonary comorbidities that do not allow participation in the program\n* Medical contraindications for physical activity\n* Lack of patient capacity to consent\n* Pregnancy/breastfeeding\n* Acute infections/fever\n* Participation in another clinical intervention study'}, 'identificationModule': {'nctId': 'NCT07464457', 'acronym': 'NEOPRO-SIT', 'briefTitle': 'Effects of Neoadjuvant Prehabilitation on Post-Interventional Physical and Psychological Outcomes in Oncology Patients With Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Muenster'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2025-1006-f-S'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control arm', 'description': 'Standard of care', 'interventionNames': ['Behavioral: standard of care']}, {'type': 'EXPERIMENTAL', 'label': 'Prehabilitation arm', 'description': 'Targeted execercise and psychooncological program', 'interventionNames': ['Behavioral: Prehabilitation']}], 'interventions': [{'name': 'Prehabilitation', 'type': 'BEHAVIORAL', 'description': 'Targeted exercise and psychooncological program', 'armGroupLabels': ['Prehabilitation arm']}, {'name': 'standard of care', 'type': 'BEHAVIORAL', 'description': 'Clinical routine as applied in Germany', 'armGroupLabels': ['Control arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48149', 'city': 'Münster', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Mira Meyer-Ács', 'role': 'CONTACT', 'email': 'mira.meyer-acs@ukmuenster.de', 'phone': '+49 251 83 49134'}], 'facility': 'University hospital Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'centralContacts': [{'name': 'Mira Meyer-Ács', 'role': 'CONTACT', 'email': 'mira.meyer-acs@ukmuenster.de', 'phone': '+49 251 8349134'}], 'overallOfficials': [{'name': 'Annalen Bleckmann, Univ.-Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University hospital Münster'}, {'name': 'Philipp Lenz, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University hospital Münster'}, {'name': 'Markus Ramm, Dr. rer. nat.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University hospital Münster'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD are subject to data protection'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Priv.-Doz. Dr. med. Philipp Lenz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'CEO of the West German Cancer Center', 'investigatorFullName': 'Priv.-Doz. Dr. med. Philipp Lenz', 'investigatorAffiliation': 'University Hospital Muenster'}}}}