Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2026-01-21 @ 9:22 AM
Study NCT ID:
NCT05790850
Status:
RECRUITING
Last Update Posted:
2024-12-16
First Post:
2023-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-Habilitation with Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D000093284', 'term': 'Non-Muscle Invasive Bladder Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-10', 'studyFirstSubmitDate': '2023-03-16', 'studyFirstSubmitQcDate': '2023-03-28', 'lastUpdatePostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patient-reported days devoted to solitary psychological support', 'timeFrame': '30 days', 'description': 'Patient-reported days devoted to self-directed solitary psychological support related to cancer treatment during a 30 day period pre-operatively in the pre-habilitation program group'}, {'measure': 'Number of patient-reported days devoted to exercise', 'timeFrame': '30 days', 'description': 'Patient-reported minutes per day devoted to high-intensity exercise during a 30 day period pre-operatively in the pre-habilitation program group'}], 'secondaryOutcomes': [{'measure': 'Post-operative complication rate', 'timeFrame': '30 days post-operatively', 'description': 'Percentage of patients with a Clavien Grade 3 or higher complications at 30-days post-operatively'}, {'measure': 'Patient-reported health-related quality of life as assessed by the European Organization for Research and Treatment of Cancer (EORTC) questionnaire.', 'timeFrame': '4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively', 'description': 'The EORTC QLQ BLM 30 consists of 30 questions developed to assess the quality of life of cancer patients. It incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. Several single-item symptom measures commonly reported by cancer patients (dyspnea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease. The questionnaire was designed to be cancer-specific, multidimensional in structure, appropriate for self-administration, and applicable across a range of cultural settings. All of the scales and single-item measures range in score from 0 to 100. A higher score represents higher symptomatology in each respective domain.'}, {'measure': 'Peak oxygen uptake as measured on cardiopulmonary exercise testing (CPET)', 'timeFrame': '4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively', 'description': 'Maximal oxygen uptake will be measured using a cycle ergometer-based cardiopulmonary exercise testing (CPET).'}, {'measure': 'Dispositional mindfulness as assessed by the Mindfulness Awareness Attention Scale (MAAS)', 'timeFrame': '4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively', 'description': 'The Mindfulness Awareness Attention Scale (MAAS) is a 15-item scale designed to assess a core characteristic of mindfulness, namely, a receptive state of mind in which attention, informed by a sensitive awareness of what is occurring in the present, simply observes what is taking place. Total scores range from 0 to 6; higher scores indicate higher dispositional mindfulness.'}, {'measure': 'Perceived stress as assessed by the Perceived Stress Scale 10 (PSS 10)', 'timeFrame': '4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively', 'description': "the Perceived Stress Scale 10 (PSS 10) is a 10-item survey that captures the respondent's stress level in the past month and uses a Likert scale to assess different domains of stress. Individual scores on the PSS 10 can range from 0 to 40 with higher scores indicating higher perceived stress."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mindfulness', 'Meditation', 'Physical Exercise', 'Pre-habilitation'], 'conditions': ['Bladder Cancer', 'Non-muscle-invasive Bladder Cancer', 'Muscle-Invasive Bladder Carcinoma']}, 'descriptionModule': {'briefSummary': 'The PRIMER (Pre-Habilitation With Mindfulness and Exercise for Patients Undergoing Radical Cystectomy) trial is a pilot designed to estimate the feasibility of integrating a home-based pre-operative exercise and mindfulness program (pre-habilitation program) for patients scheduled to undergo radical cystectomy for bladder cancer in an attempt to improve both physical and psychological conditioning pre-operatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged ≥18 years of age\n* Good surgical candidate determined by treating surgeon\n* Histologically documented muscle invasive urothelial carcinoma of the bladder, high-risk non-muscle invasive bladder cancer, non-muscle invasive bladder cancer refractory to BCG, cisplatin ineligible muscle invasive bladder cancer receiving upfront cystectomy, urothelial carcinoma of the bladder with variant histology\n* Adequate Organ Function per protocol definition\n* ECOG performance status ≤2\n* Received medical clearance to complete cardiopulmonary exercise testing\n* Willing to use the personal or study provided devices for monitoring and performing the exercise routines.\n* Fluent in English or Spanish for the EORTC QLQ questionnaire\n* No known contraindications to high intensity exercise\n\nExclusion Criteria:\n\n* Contraindications to participating in aerobic exercise\n* Currently participating in an aerobic exercise program\n* New onset chest pain nor dyspnea with exertion\n* Histologically documented micropapillary or sarcomatoid bladder cancer\n* Distant metastatic carcinoma'}, 'identificationModule': {'nctId': 'NCT05790850', 'acronym': 'PRIMER', 'briefTitle': 'Pre-Habilitation with Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Pre-Habilitation with Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)', 'orgStudyIdInfo': {'id': 'HSR210502'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Usual preoperative care prior to radical cystectomy'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Preoperative pre-habilitation', 'interventionNames': ['Behavioral: Pre-operative physical exercise', 'Behavioral: Pre-operative mindfulness meditation practice']}], 'interventions': [{'name': 'Pre-operative physical exercise', 'type': 'BEHAVIORAL', 'description': 'Virtual instructor-guided twice weekly cycling-based high-intensity aerobic exercise program for a total of 30 days. Participants will use a study provided recumbent exercise bike and wristband fitness tracker to exercise and log the number of days they exercise with an instructor and self-directed cycling.', 'armGroupLabels': ['Intervention']}, {'name': 'Pre-operative mindfulness meditation practice', 'type': 'BEHAVIORAL', 'description': 'Daily self-directed mindfulness practice involving a guided imagery meditation for a total of 30 days. Participants will use a study provided guided-imagery meditation audio file loaded to a study provided wristband fitness tracker. Participants will log the number of days they listen to the audio file or participate in self-directed solitary psychological support.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christine Ibilibor', 'role': 'CONTACT', 'email': 'CI5D@virginia.edu'}, {'name': 'Ashley Byrne', 'role': 'CONTACT', 'email': 'aeb6q@uvahealth.org'}, {'name': 'Christine Ibilibor, MD', 'role': 'CONTACT'}], 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'centralContacts': [{'name': 'Christine Ibilibor', 'role': 'CONTACT', 'email': 'ci5d@virginia.edu', 'phone': '4349240871'}, {'name': 'Francesca Whitefield', 'role': 'CONTACT', 'email': 'fbw3mg@virginia.edu', 'phone': '4349240871'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Summary of trial outcome data through publication or grant reporting requirements.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Cancer Society, Inc.', 'class': 'OTHER'}, {'name': 'Integrated Translational Health Research Institute of Virginia (iTHRIV)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Christine Ibilibor, MD', 'investigatorAffiliation': 'University of Virginia'}}}}