Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2025-12-30 @ 4:55 PM
Study NCT ID:
NCT06125795
Status:
RECRUITING
Last Update Posted:
2025-09-29
First Post:
2023-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess Change in Functioning and Health Related Quality of Life in Adult Participants With Chronic Lymphocytic Leukemia (CLL) Receiving Oral Treatments in Routine Clinical Practice in Spain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D057240', 'term': 'Patient Preference'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2023-10-24', 'studyFirstSubmitQcDate': '2023-11-08', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Participant Functioning Measured Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) with the EORTC Chronic Lymphocytic Leukemia 17 (EORTC-CLL17) Supplement', 'timeFrame': 'Up to 27 Months', 'description': "The EORTC-CLL17 is a specific questionnaire that supplements the EORTC QLQ-C30 for participants with CLL.\n\nEORTC-CLL17 comprises 17 items divided into three subscales: symptom burden, physical condition/fatigue, and worries/fears about the health and functioning. The scores of each subscale are calculated based on the EORTC's protocol and then transformed to a 0 to 100 scale. A high score represents a high level of symptomology high level of physical condition/fatigue, and a high level of worries/fears about the health and functioning.\n\nEORTC QLQ-C30 is a questionnaire to assess the quality of life (QoL) of cancer participants. It is composed of five functional scales, three symptom scales, a global health status/QoL scale, and six single items. A high score represents high level of functioning, or QoL, but a high level of symptomology/problems."}, {'measure': 'Change in Participant Health-related Quality of Life (HRQoL)Measured Using the EORTC QLQ-C30 with the EORTC-CLL17 Supplement', 'timeFrame': 'Up to 27 Months', 'description': "The EORTC-CLL17 is a specific questionnaire that supplements the EORTC QLQ-C30 for participants with CLL.\n\nEORTC-CLL17 comprises 17 items divided into three subscales: symptom burden, physical condition/fatigue, and worries/fears about the health and functioning. The scores of each subscale are calculated based on the EORTC's protocol and then transformed to a 0 to 100 scale. A high score represents a high level of symptomology high level of physical condition/fatigue, and a high level of worries/fears about the health and functioning.\n\nEORTC QLQ-C30 is a questionnaire to assess the QoL of cancer participants. It is composed of five functional scales, three symptom scales, a global health status/QoL scale, and six single items. A high score represents a high level of functioning, or QoL, but a high level of symptomology/problems."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Lymphocytic Leukemia', 'Bruton Tyrosine Kinase Inhibitor', 'Patient-Reported Outcomes Measure', 'Patient-Reported Experience Measure', 'Venetoclax', 'Venclexta', 'Venclyxto', 'ABT-199', 'Patient Preferences', 'Cancer', 'PROVIDENCE'], 'conditions': ['Chronic Lymphocytic Leukemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=P24-280', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "Chronic lymphocytic leukemia (CLL) is the most common leukemia in the Western world. Since in most cases CLL remains an incurable disease, the goals of therapy are to improve quality of life and to prolong survival. This study will evaluate the participant's related outcomes and experience of CLL in adult participants who are treated in the Spain.\n\nStudy participants will receive oral treatments for CLL as prescribed by their study doctor in accordance with approved local label. Adult participants prescribed various treatments will be enrolled. Around 132 participants will be enrolled in the study in sites in Spain.\n\nParticipants will receive oral treatments for CLL according to the approved local label. The overall study duration will be 18 months.\n\nThere is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult participants diagnosed with chronic lymphocytic leukemia (CLL) treated with fixed-time duration (FTD) or continuous oral regimens who attend to a regular follow up visit at a Spanish participating hospital will be eligible to participate in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have documented chronic lymphocytic leukemia (CLL) according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.\n* Under oral treatment for CLL, either first-line or relapsed/refractory (R/R) therapy.\n* Treatment for CLL started 9 months (+/- 4 weeks) before inclusion for first-line therapy or 21 months (+/- 4 weeks) before inclusion for R/R, under authorized conditions.\n* In the opinion of the investigator, cognitive ability to understand and answer the questionnaires specified in the study protocol.\n* Able to comply with the study protocol in the investigator's judgment.\n\nExclusion Criteria:\n\n* Currently receiving any chemotherapy or chemoimmunotherapy.\n* Transformation of CLL to aggressive non-Hodgkin's lymphoma (NHL) (Richter's transformation or pro-lymphocytic leukaemia).\n* Currently participating in interventional research (not including non-interventional study, post-marketing observational study, or registry participation).\n* Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study."}, 'identificationModule': {'nctId': 'NCT06125795', 'acronym': 'PROVIDENCE', 'briefTitle': 'A Study to Assess Change in Functioning and Health Related Quality of Life in Adult Participants With Chronic Lymphocytic Leukemia (CLL) Receiving Oral Treatments in Routine Clinical Practice in Spain', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Non-interventional Prospective Descriptive Study to Assess the Impact on Patient´s Well-being of Fixed-time Duration (FTD) and Continuous Oral Regimens for Newly Diagnosed and Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) in Routine Clinical Practice in Spain', 'orgStudyIdInfo': {'id': 'P24-280'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic Lymphocytic Leukemia (CLL) Participants', 'description': 'Participants will receive oral treatments for CLL in accordance with approved local label.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '01009', 'city': 'Vitoria-Gasteiz', 'state': 'Alava', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'HUA - Txagorritxu /ID# 258263', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}, {'zip': '08423', 'city': 'Manresa', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Sant Joan de Deu de Manresa /ID# 258266', 'geoPoint': {'lat': 41.72815, 'lon': 1.82399}}, {'zip': '08221', 'city': 'Terrassa', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitari Mútua Terrassa /ID# 258267', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}, {'zip': '11407', 'city': 'Jerez de la Frontera', 'state': 'Cadiz', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Jerez De La Frontera /ID# 258282', 'geoPoint': {'lat': 36.68645, 'lon': -6.13606}}, {'zip': '39770', 'city': 'Laredo', 'state': 'Cantabria', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Comarcal de Laredo /ID# 258262', 'geoPoint': {'lat': 43.4098, 'lon': -3.41613}}, {'zip': '39008', 'city': 'Santander', 'state': 'Cantabria', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Marques de Valdecilla /ID# 258261', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '14004', 'city': 'Córdoba', 'state': 'Cordoba', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Reina Sofia /ID# 271507', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '35019', 'city': 'Las Palmas de Gran Canaria', 'state': 'Las Palmas', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Dr. Negrin /ID# 258285', 'geoPoint': {'lat': 28.10178, 'lon': -15.41573}}, {'zip': '24080', 'city': 'León', 'state': 'Leon', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario de León /ID# 271526', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}, {'zip': '28942', 'city': 'Fuenlabrada', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario de Fuenlabrada /ID# 258275', 'geoPoint': {'lat': 40.28419, 'lon': -3.79415}}, {'zip': '30120', 'city': 'El Palmar', 'state': 'Murcia', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario Virgen de la Arrixaca /ID# 262173', 'geoPoint': {'lat': 37.93939, 'lon': -1.16095}}, {'zip': '36213', 'city': 'Vigo', 'state': 'Pontevedra', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Meixoeiro (CHUVI) /ID# 258286', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'zip': '33394', 'city': 'Gijón', 'state': 'Principality of Asturias', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital de Cabueñes /ID# 263307', 'geoPoint': {'lat': 43.53573, 'lon': -5.66152}}, {'zip': '33011', 'city': 'Oviedo', 'state': 'Principality of Asturias', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Central de Asturias /ID# 271508', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'zip': '48960', 'city': 'Galdakao', 'state': 'Vizcaya', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario de Galdakao /ID# 258264', 'geoPoint': {'lat': 43.23073, 'lon': -2.8429}}, {'zip': '08906', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital de Sant Joan Despi Moises Broggi /ID# 262284', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '18014', 'city': 'Granada', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de las Nieves /ID# 258280', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '27004', 'city': 'Lugo', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Lucus Augusti /ID# 271542', 'geoPoint': {'lat': 43.00992, 'lon': -7.55602}}, {'zip': '28006', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario de La Princesa /ID# 271506', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28007', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Maranon /ID# 258273', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Fundacion Jimenez Diaz /ID# 258269', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre /ID# 258271', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz /ID# 258270', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '30008', 'city': 'Murcia', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital General Universitario Morales Meseguer /ID# 258284', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'zip': '41009', 'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen Macarena /ID# 258279', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'centralContacts': [{'name': 'AbbVie Spain Medical Info iKnow', 'role': 'CONTACT', 'email': 'medical_info_spain@abbvie.com', 'phone': '+34 913-343-922'}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}