Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-25 @ 2:24 PM
Study NCT ID:
NCT06912659
Status:
RECRUITING
Last Update Posted:
2025-06-29
First Post:
2025-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The BALANCE Study: A Study in Spain to Find Out Whether a Patient Support Program Helps People With Pulmonary Fibrosis Who Take Nintedanib
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 493}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-27', 'studyFirstSubmitDate': '2025-04-03', 'studyFirstSubmitQcDate': '2025-04-03', 'lastUpdatePostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient satisfaction with Patient Support Program (PSP) Balance Program at baseline using the Baker Questionnaire.', 'timeFrame': 'at Baseline', 'description': 'Baker Questionnaire: This questionnaire contains 18 items divided into four domains. related to general satisfaction, the care provided by the professional, the time dedicated to the consultation and the relationship with the professional. There is no cut point published.\n\nItems in both modules have a five-option numeric score that ranges from 1 "Not at all" to 5 "Extremely". Total Baker score ranges from 0 to 90, with higher numbers indicating a greater satisfaction. In this study the mean value will be include.'}], 'secondaryOutcomes': [{'measure': '1. Change in the satisfaction with Patient Support Program (PSP) Balance Program at 6 and 12-month follow-up after inclusion in the study, using the Baker Questionnaire.', 'timeFrame': 'up to 12 months', 'description': 'Baker Questionnaire: This questionnaire contains 18 items divided into four domains. related to general satisfaction, the care provided by the professional, the time dedicated to the consultation and the relationship with the professional. There is no cut point published.\n\nItems in both modules have a five-option numeric score that ranges from 1 "Not at all" to 5 "Extremely". Total Baker score ranges from 0 to 90, with higher numbers indicating a greater satisfaction. In this study the mean value will be include.'}, {'measure': 'Patient satisfaction with PSP Balance Program at baseline, 6 and 12 months after the inclusion in the study using the Likert scale.', 'timeFrame': 'at baseline and up to 12 months', 'description': 'Likert scale: This questionnaire contains 8 items. related to satisfaction with PSP, the care provided by the professional, the time dedicated to the consultation and the relationship with the professional. There is no cut point published.\n\nItems have a four-option numeric score that ranges from 1 "Not at all" to 4 "Extremely".'}, {'measure': 'Dosing pattern of nintedanib calculated as absolute number of doses taken correctly divided by all the doses prescribed in that period (6 and 12 months)', 'timeFrame': 'up to 12 months'}, {'measure': 'Time from first dose to permanent discontinuation of nintedanib within 12-month follow-up.', 'timeFrame': 'up to 12 months'}, {'measure': 'Absolute number of nintedanib dose interruptions.', 'timeFrame': 'up to 12 months'}, {'measure': 'Health-Related Quality of Life (HRQoL) at baseline and 12-month follow-up using the L-PF Impacts Questionnaire.', 'timeFrame': 'at baseline and up to 12 months', 'description': 'Total score (from 0 to 100 points) and symptoms, impacts, dyspnea, cough and fatigue scores obtained in the L-PF Questionnaire at each visit\n\nL-PF Impacts Questionnaire:\n\nThis questionnaire contains 44 items divided into two modules. The Impacts module (21 items) assesses multiple aspects of the quality of life with a recall period of 1 week. The questionnaire was developed recently (before it was used in Idiopathic Pulmonary Fibrosis (IPF) patients only) and there is no cut point published. The Symptoms module yields three domain scores: 1) dyspnea, 2) cough and 3) fatigue as well as a total Symptoms score. Items in both modules (L-PF Impacts and L-PF Symptoms) have a five-option numeric score that ranges from 0 "Not at all" to 4 "Extremely". Total L-PF score ranges from 0 to 100, with higher numbers indicating a greater impairment.'}, {'measure': 'Anxiety and depression scores in Hospital Anxiety and Depression Scale (HADS) Questionnaire at baseline and 12-month follow-up.', 'timeFrame': 'at baseline and up to 12 months', 'description': 'Total score (from 0 to 100 points) obtained in the HADS Questionnaire at each visit.\n\nHADS Questionnaire:\n\nThe Hospital Anxiety and Depression Scale-Spanish Version is a 14-item self-report screening scale for anxiety and depression in Spanish-speaking populations. HADS consists of a 7-item anxiety subscale and a 7-item depression subscale. Each item scores on a 4-point Likert scale.\n\nEach item is scored on a scale of 0 = best to 3 = worst, which means that the maximum score for each subscale is 21. To interpret the results, the total sums of each subscale are considered separately. A score of 0 to 7 on any of the subscales is generally considered to be an absence of relevant disorder, 8 to 10 indicates the presence of borderline or borderline symptoms, and a score of 11 or higher suggests a significant presence of anxiety or depression.'}, {'measure': 'Disease symptoms score in Living with Pulmonary Fibrosis (L-PF) Symptoms Questionnaire at baseline and 12 months follow-up.', 'timeFrame': 'at baseline and up to 12 months', 'description': 'Total score (from 0 to 100 points) obtained in the L-PF Questionnaire at each visit.\n\nL-PF Symptoms Questionnaire:\n\nThis questionnaire contains 44 items divided into two modules. The Symptoms module (23 items) rates shortness of breath, cough, and fatigue in the past 24 hours. The questionnaire was developed recently (before it was used in IPF patients only) and there is no cut point published.\n\nItems in both modules (L-PF Impacts and L-PF Symptoms) have a five-option numeric score that ranges from 0 "Not at all" to 4 "Extremely". Total L-PF score ranges from 0 to 100, with higher numbers indicating a greater impairment.'}, {'measure': 'Absolute number of visits to emergency service and hospitalization related to Interstitial Lung Disease (ILD) between baseline and 12-month follow-up.', 'timeFrame': 'up to 12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Fibrosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "The aim of this study is to describe patients' satisfaction with Patient Support Program (Balance Program), Quality of Life and depression symptoms, dosing pattern, disease symptoms, adverse events and nintedanib discontinuation (both permanent and non-permanent) from study inclusion to 12 months of follow-up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study will include patients with IPF and PPF (other than IPF) participating in the PSP Balance Program. The study duration will be from the start of the recruitment period (which will last approximately 6 months) to the last follow-up visit of the last patient (approximately 18 months of total study period). Patients will be followed-up at 6 months and at 12 months.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Adults (≥18 years old at baseline).\n* Patients included in the Patient Support Program (PSP) Balance Program.\n* Ability to read and speak Spanish correctly according to the investigator criteria.\n* Agree to participate and signing informed consent at baseline.\n\nExclusion criteria\n\n\\- Suspicion or diagnosis of any relevant cognitive impairment at the discretion of the investigator.'}, 'identificationModule': {'nctId': 'NCT06912659', 'briefTitle': 'The BALANCE Study: A Study in Spain to Find Out Whether a Patient Support Program Helps People With Pulmonary Fibrosis Who Take Nintedanib', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Non-interventional Prospective Study in Patients With Pulmonary Fibrosis Treated With Nintedanib Participating in a Patient Support Program in Spain, to Describe Patient Satisfaction With the Program and to Monitor Quality of Life - BALANCE Study', 'orgStudyIdInfo': {'id': '1199-0575'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients participating in the PSP Balance Program'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08005', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'espana@bitrialsupport.com', 'phone': '900876092'}], 'facility': 'Evidenze Health España S.L.U', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127'}]}, 'ipdSharingStatementModule': {'url': 'https://www.mystudywindow.com/msw/datasharing', 'timeFrame': 'One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.', 'ipdSharing': 'YES', 'description': 'Once the criteria in section \'time frame\' are fulfilled, researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.', 'accessCriteria': "For study documents - upon signing of a 'Document Sharing Agreement'.\n\nFor study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}