Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT03435120
Status:
COMPLETED
Last Update Posted:
2020-03-02
First Post:
2018-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quality of Life Study Breakthrough Cancer Pain Treated in Medical Oncology Services (CAVIDIOM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059390', 'term': 'Breakthrough Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-28', 'studyFirstSubmitDate': '2018-01-29', 'studyFirstSubmitQcDate': '2018-02-14', 'lastUpdatePostDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in quality of life of the patients', 'timeFrame': 'Up to 4 weeks', 'description': 'Changes according to EQ-5D-5L questionnaire'}], 'secondaryOutcomes': [{'measure': 'Characteristics of patients', 'timeFrame': 'At baseline', 'description': 'Kind of tumor.'}, {'measure': 'Characteristics of patients', 'timeFrame': 'At baseline', 'description': 'Demographic data'}, {'measure': 'Characteristics of patients', 'timeFrame': 'At baseline', 'description': 'ECOG'}, {'measure': 'Management of cancer breakthrough pain.', 'timeFrame': 'Up to 4 weeks', 'description': 'Cancer breakthrough pain characteristics (time until maximum intensity)'}, {'measure': 'Management of cancer breakthrough pain.', 'timeFrame': 'Up to 4 weeks', 'description': 'Cancer breakthrough pain evolution (duration and management)'}, {'measure': 'Anxiety and depression status and the possible relationship between these factors and quality of life.', 'timeFrame': 'Up to 4 weeks', 'description': 'Goldberg Anxiety and Depression Scale.'}, {'measure': 'Sleep quality and the possible relationship between this factor and quality of life.', 'timeFrame': 'Up to 4 weeks', 'description': 'MOS sleep questionnaire'}, {'measure': 'Evaluate caregivers effort', 'timeFrame': 'Up to 4 weeks', 'description': 'Results according to caregivers effort Index'}, {'measure': 'Perceived assistance quality by patients', 'timeFrame': 'Up to 4 weeks', 'description': 'Results according to Sociofamily evaluation scale of "Gijon"'}, {'measure': 'Improvement impression perceived by patients', 'timeFrame': 'Up to 4 weeks', 'description': 'Results according to assessment of perceived quality (questionnaire of the Ministry of Health and Consumer Affairs)'}, {'measure': 'Improvement impression perceived by patients', 'timeFrame': 'Up to 4 weeks', 'description': 'Results according to Satisfaction questionnaire PGI-I'}, {'measure': 'Improvement impression perceived by patients', 'timeFrame': 'Up to 4 weeks', 'description': 'Results according to Satisfaction questionnaire CGI-I'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breakthrough Cancer Pain', 'Quality of life', 'Medical Oncology'], 'conditions': ['Breakthrough Pain']}, 'descriptionModule': {'briefSummary': 'In cancer patients, pain is one of the most common symptoms. The range of reported prevalence of pain varies from 33% to 64% including different stages of cancer, during or after anticancer treatment. Moreover, despite the optimal management of basal chronic pain, 66% of these patients have reported breakthrough pain which has a severe impact on quality of life. There is insufficient clinical information on the quality of life of cancer patients with breakthrough pain treated in medical oncology services according to routine clinical practice. For this reason we consider it is appropriate to prospectively evaluate the quality of life of cancer patients with cancer breakthrough pain in medical oncology services as well as other factors that can affect quality of life. This post-authorization observational study will assess the quality of life of cancer patients with breakthrough cancer pain treated in medical oncology services in Spanish hospitals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with breakthrough cancer pain treated in Medical Oncology services', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\> 18 years\n* Patients with histologically confirmed neoplasia\n* Patients attended in medical oncology consultations\n* Life expectancy \\> 3 months\n* Patients with baseline controlled cancer pain with opioids who are diagnosed of breakthrough cancer pain by Davies algorithm\n* Written informed consent\n\nExclusion Criteria:\n\n* Untreated patients with opioids for baseline pain\n* Patients who are not opioid tolerant\n* Serious psychiatric disorder or any disease or condition that prevents the collection of data\n* Patients with evidence of opioid addiction or history of drug or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT03435120', 'acronym': 'CAVIDIOM', 'briefTitle': 'Quality of Life Study Breakthrough Cancer Pain Treated in Medical Oncology Services (CAVIDIOM)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Angelini Farmacéutica'}, 'officialTitle': 'Quality of Life Study in Patients With Breakthrough Cancer Pain Treated in Medical Oncology Services', 'orgStudyIdInfo': {'id': 'ANG-ANA-2017-01 (CAVIDIOM)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breakthrough Cancer Pain', 'description': 'No intervention (Non Interventional Study)', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Breakthrough Cancer Pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15706', 'city': 'Santiago de Compostela', 'state': 'A Coruña', 'country': 'Spain', 'facility': 'Complexo Hospitalario Universitario de Santiago', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'city': 'Alcalá de Henares', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Principe de Asturias', 'geoPoint': {'lat': 40.48205, 'lon': -3.35996}}, {'city': 'Palma de Mallorca', 'state': 'Palma', 'country': 'Spain', 'facility': 'Hospital Universitari Son Espases', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '33011', 'city': 'Oviedo', 'state': 'Principality of Asturias', 'country': 'Spain', 'facility': 'Hospital Universitario Central de Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'zip': '43204', 'city': 'Reus', 'state': 'Tarragona', 'country': 'Spain', 'facility': 'Hospital Universitari de San Joan de Reus', 'geoPoint': {'lat': 41.15612, 'lon': 1.10687}}, {'zip': '43500', 'city': 'Tortosa', 'state': 'Tarragona', 'country': 'Spain', 'facility': 'Hospital Verge de la Cinta', 'geoPoint': {'lat': 40.81249, 'lon': 0.5216}}, {'zip': '10002', 'city': 'Cáceres', 'country': 'Spain', 'facility': 'Hospital San Pedro de Alcántara', 'geoPoint': {'lat': 39.47649, 'lon': -6.37224}}, {'zip': '25198', 'city': 'Lleida', 'country': 'Spain', 'facility': 'Hospital Arnau de Vilanova', 'geoPoint': {'lat': 41.61674, 'lon': 0.62218}}, {'zip': '28023', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clínico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '37007', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Hospital Universitario de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'city': 'Vigo', 'country': 'Spain', 'facility': 'Hospital Alvaro Cunqueiro', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Universitario Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'Carlos Camps Herrero', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital General Universitario de Valencia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Angelini Farmacéutica', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Apices Soluciones S.L.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}