Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-28 @ 5:16 AM
Study NCT ID:
NCT05480735
Status:
UNKNOWN
Last Update Posted:
2022-10-31
First Post:
2022-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EffectiveNess of a Multimodal preHAbilitation Program in patieNts With Bladder canCEr Undergoing Cystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082622', 'term': 'Preoperative Exercise'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 154}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-27', 'studyFirstSubmitDate': '2022-07-14', 'studyFirstSubmitQcDate': '2022-07-27', 'lastUpdatePostDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Overall and bladder-cancer specific survival', 'timeFrame': '0-60 months', 'description': 'Exploratory outcome'}, {'measure': 'Progression-free survival', 'timeFrame': '0-60 months', 'description': 'Exploratory outcome'}], 'primaryOutcomes': [{'measure': 'Complications', 'timeFrame': '0-12 weeks post-surgery (measured 4 weeks and 12 weeks post-surgery)', 'description': 'The proportion of patients having Clavien-Dindo grade 2 or higher perioperative complications; obtained from the medical records'}], 'secondaryOutcomes': [{'measure': 'High grade complications', 'timeFrame': '0-12 weeks post-surgery', 'description': 'Clavien Dindo grade 3 or higher'}, {'measure': 'Duration of hospital stay', 'timeFrame': '0-12 weeks post-surgery', 'description': 'Time from admission until hospital discharge'}, {'measure': 'Readmissions', 'timeFrame': '0-12 weeks post-surgery', 'description': 'Hospital readmission as recorded in medical file'}, {'measure': 'Disease status', 'timeFrame': '0-12 weeks post-surgery', 'description': 'Progression/recurrence, any additional treatment as recorded in medical file'}, {'measure': 'Change in cardiorespiratory fitness', 'timeFrame': 'T0a (baseline), T1 (within 1 week before surgery)', 'description': 'Assessed via cardiopulmonary exercise test (CPET)'}, {'measure': 'Change in muscle strength', 'timeFrame': 'T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)', 'description': 'Grip strength'}, {'measure': 'Change in muscle strength', 'timeFrame': 'T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)', 'description': '30s chair stands'}, {'measure': 'Change in physical performance', 'timeFrame': 'T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)', 'description': 'Short Physical Performance Battery (SPPB)'}, {'measure': 'Change in nutritional status', 'timeFrame': 'T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)', 'description': 'Short Form- Patient Generated Subjective Global Assessment (SF-PGSA)'}, {'measure': 'Change in body composition', 'timeFrame': 'T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)', 'description': 'Fat free mass and fat mass assessed by Scale Bioelectrical Impedance Analysis (BIA)'}, {'measure': 'Nil per mouth consumption during hospitalization', 'timeFrame': '0-12 weeks post-surgery', 'description': 'The total days as recorded in medical file'}, {'measure': 'Change in weight', 'timeFrame': 'T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)', 'description': 'Measured in KG'}, {'measure': 'Height', 'timeFrame': 'T0a (baseline) - T3 (12 weeks post-surgery)', 'description': 'Measured in cm'}, {'measure': 'Change in smoking status', 'timeFrame': 'T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)', 'description': 'Self-developed questionnaire'}, {'measure': 'Sense of coherence (SOC)', 'timeFrame': 'T0a (baseline)', 'description': '13-item SOC questionnaire'}, {'measure': 'Change in fatigue', 'timeFrame': 'T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)', 'description': 'MFI questionnaire'}, {'measure': 'Change in HRQoL', 'timeFrame': 'T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)', 'description': 'EORTC QLQ-C30'}, {'measure': 'Change in muscle invasive bladder cancer specific scores', 'timeFrame': 'T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)', 'description': 'EORTC QLQ-BLM30'}, {'measure': 'Change in health status', 'timeFrame': 'T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)', 'description': 'EQ-5D-5L'}, {'measure': 'Change in physical activity', 'timeFrame': 'T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)', 'description': 'SQUASH questionnaire'}, {'measure': 'Change in anxiety and depression', 'timeFrame': 'T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)', 'description': 'HADS questionnaire'}, {'measure': 'Intervention costs', 'timeFrame': 'T0a (baseline) - T3 (12 weeks post-surgery)', 'description': 'Cost analysis'}, {'measure': 'Healthcare resources consumption', 'timeFrame': 'T0a (baseline) - T3 (12 weeks post-surgery) (measured within 1 week before surgery, 4 and 12 weeks post-surgery and if applicable : after neoadjuvant chemotherapy)', 'description': 'Medical Consumption Questionnaire (iMCQ)'}, {'measure': 'Work status', 'timeFrame': 'T0a (baseline) - T3 (12 weeks post-surgery)', 'description': 'Productivity Cost Questionnaire (iPCQ)'}, {'measure': 'Satisfaction with prehabilitation in intervention group and evaluation in control group', 'timeFrame': 'T3 (12 weeks post-surgery)', 'description': 'Self-developed questionnaire'}, {'measure': 'Non participation analysis', 'timeFrame': 'T0a (baseline)', 'description': 'Identify clinical and sociodemographic variables that are related to non-participation of patients in this trial via questionnaire'}, {'measure': 'Hypoxia', 'timeFrame': 'T3 (12 weeks post-surgery)', 'description': 'To study the effectiveness of the prehabilitation program in terms of inducing favorable changes in tumor hypoxia markers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prehabilitation', 'bladder cancer', 'exercise', 'smoking cessation', 'nutritional support', 'surgical complications', 'cystectomy'], 'conditions': ['Bladder Carcinoma']}, 'referencesModule': {'references': [{'pmid': '36882246', 'type': 'DERIVED', 'citation': 'Akdemir E, Sweegers MG, Vrieling A, Rundqvist H, Meijer RP, Leliveld-Kors AM, van der Heijden AG, Rutten VC, Koldewijn EL, Bos SD, Wijburg CJ, Marcelissen TAT, Bongers BC, Retel VP, van Harten WH, May AM, Groen WG, Stuiver MM. EffectiveNess of a multimodal preHAbilitation program in patieNts with bladder canCEr undergoing radical cystectomy: protocol of the ENHANCE multicentre randomised controlled trial. BMJ Open. 2023 Mar 7;13(3):e071304. doi: 10.1136/bmjopen-2022-071304.'}]}, 'descriptionModule': {'briefSummary': 'Currently, the potential value of a multimodal prehabilitation program in bladder cancer has not been extensively studied. The investigators designed the ENHANCE study to assess the effect of a structured multimodal prehabilitation program in 154 patients with bladder cancer on the number (primary endpoint) and severity of complications within 90 days, length of hospital stay, readmissions, physical fitness, muscle strength, physical functioning, nutritional status, smoking behaviour, anxiety and depression, fatigue, quality of life, physical activity, tumor tissue characteristics, and healthcare costs.', 'detailedDescription': 'The ENHANCE study is a multicenter, randomized controlled trial. The intervention group will participate in a prehabilitation program of 4-6 weeks before surgery, and additionally during neoadjuvant chemotherapy if applicable. The prehabilitation program consist of a tailored exercise program, nutritional support and if relevant smoking cessation and/or psychological counselling. The exercise program is under supervision of an oncology specialized physiotherapist and comprises aerobic-, resistance- and breathing- and relaxation exercises. Patients will be asked to be physically active for an additional 2 times a week for at least 30 minutes. A dietician will provide nutritional support and give dietary advice to increase protein intake to enhance the anabolic effect on muscle mass. Additionally, patients will receive a supplement containing 30 g of high quality whey-protein daily preferably before sleep and after the supervised training. Patients who score high on anxiety and depression will be offered a referral to a psychological support. Intensive counselling and nicotine replacement therapy will be offered to all patients who smoke. Patients in the intervention group will be asked to keep a diary to track unsupervised activity and to track intake of the protein supplementation. The physical activity level in both groups will be obtained via questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed, primary, bladder cancer (cTa-4N0/N+M0),\n* Planned to undergo radical cystectomy,\n* Age ≥ 18 years.\n\nExclusion Criteria:\n\n* Subjects with severe cognitive or psychiatric disorders,\n* Subjects who are operated within 3 weeks,\n* Subjects with insufficient command of the Dutch language, which precludes them from following study instructions or completing study questionnaires,\n* Subjects who have contraindications to safely perform exercise training or testing (i.e., CPET),\n* Subject who are unable or unwilling to participate in the intervention.'}, 'identificationModule': {'nctId': 'NCT05480735', 'acronym': 'ENHANCE', 'briefTitle': 'EffectiveNess of a Multimodal preHAbilitation Program in patieNts With Bladder canCEr Undergoing Cystectomy', 'organization': {'class': 'OTHER', 'fullName': 'The Netherlands Cancer Institute'}, 'officialTitle': 'EffectiveNess of a Multimodal preHAbilitation Program in patieNts With Bladder canCEr Undergoing Cystectomy. The ENHANCE Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'NL78792.031.22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prehabilitation group', 'description': 'The intervention group will participate in a prehabilitation program of approximately 4-6 weeks before surgery, and additionally during neoadjuvant chemotherapy if applicable. The program consist of a tailored exercise program, nutritional support and if relevant smoking cessation and/or psychological counselling. The exercise program is under supervision of an oncology specialized physiotherapist and comprises aerobic-, resistance- and breathing- and relaxation exercises. A dietician will provide nutritional support and give dietary advice to increase protein intake, including a supplement containing 30 g of whey-protein daily and after supervised training. Patients who score high on anxiety and depression will be offered a referral to a psychologist. Intensive counselling and nicotine replacement therapy will be offered to all patients who smoke.\n\nPatients will be asked to keep a diary to track unsupervised activity and to track intake of the protein supplementation.', 'interventionNames': ['Behavioral: Prehabilitation']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients randomized to the control group will receive care as usual according to local ERAS guideline implementation. In addition, they will receive a leaflet with the recent guidelines regarding physical activity, dietary advice, and smoking cessation. Their actual physical activity level will be obtained via questionnaire.'}], 'interventions': [{'name': 'Prehabilitation', 'type': 'BEHAVIORAL', 'description': 'Multimodal prehabilitation program', 'armGroupLabels': ['Prehabilitation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3015 GD', 'city': 'Rotterdam', 'state': 'Doctor Molewaterplein 40', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Joost Boormans', 'role': 'CONTACT'}], 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '6525 GA', 'city': 'Nijmegen', 'state': 'Geert Grooteplein Zuid 10', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Toine van der Heijden', 'role': 'CONTACT'}], 'facility': 'Radboudumc', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '9713 GZ', 'city': 'Groningen', 'state': 'Hanzeplein 1', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Annemarie Leliveld', 'role': 'CONTACT'}], 'facility': 'UMC Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '3584 CX', 'city': 'Utrecht', 'state': 'Heidelberglaan 100', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Anne M. May, Prof. dr.', 'role': 'CONTACT', 'email': 'a.m.may@umcutrecht.nl'}], 'facility': 'UMC Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '5623 EJ', 'city': 'Eindhoven', 'state': 'Michelangelolaan 2', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Evert Koldewijn', 'role': 'CONTACT'}], 'facility': 'Catharina Ziekenhuis', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'zip': '6229 HX', 'city': 'Maastricht', 'state': 'P. Debyelaan 25', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Bart Bongers', 'role': 'CONTACT'}], 'facility': 'Maastricht UMC+', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '6815 AD', 'city': 'Arnhem', 'state': 'Wagnerlaan 55', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Carl Wijburg', 'role': 'CONTACT'}], 'facility': 'Rijnstate', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'zip': '1815 JD', 'city': 'Alkmaar', 'state': 'Wilhelminalaan 12', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Siebe Bos', 'role': 'CONTACT'}], 'facility': 'Noordwest Ziekenhuisgroep', 'geoPoint': {'lat': 52.63167, 'lon': 4.74861}}], 'centralContacts': [{'name': 'Martijn Stuiver, PhD', 'role': 'CONTACT', 'email': 'm.stuiver@nki.nl', 'phone': '+31205124136'}, {'name': 'Emine Akdemir, MSc', 'role': 'CONTACT', 'email': 'e.akdemir@nki.nl', 'phone': '+31683395101'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Patients are asked informed consent for data sharing with POLARIS consortium'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Netherlands Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'UMC Utrecht', 'class': 'OTHER'}, {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, {'name': 'Rijnstate Hospital', 'class': 'OTHER'}, {'name': 'Noordwest Ziekenhuisgroep', 'class': 'OTHER'}, {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, {'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}