Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-25 @ 8:05 PM
Study NCT ID:
NCT04213235
Status:
UNKNOWN
Last Update Posted:
2019-12-30
First Post:
2019-12-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Educational Materials Development for Physical Activity in CAncer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-25', 'studyFirstSubmitDate': '2019-12-25', 'studyFirstSubmitQcDate': '2019-12-25', 'lastUpdatePostDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Physical activity level - using Godin's Leisure Time Exercise Questionnaire (GLTEQ)", 'timeFrame': 'Change from baseline physical activity level at 4 weeks'}], 'secondaryOutcomes': [{'measure': 'quality of life - using European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire" (EORTC QLQ C-30)', 'timeFrame': 'Change from baseline physical activity level at 4 weeks'}, {'measure': 'Sedentary behavior - using Sedentary Behaviour Questionnaire (SBQ)', 'timeFrame': 'Change from baseline physical activity level at 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mixed Cancer']}, 'descriptionModule': {'briefSummary': "In cancer setting, physical exercise has emerged as an important factor to control cancer-related symptoms and improve patients' quality of life. In addition, the correlation between physical activity and survival is recently consolidating. Nevertheless, several previous studies have shown that the majority of cancer patients are insufficiently active. Written information, for example a guidebook, may be a good oppurtunity, to improve lifestyle. Developing and testing an exercise guidebook, based on Theory of Planned Behavior and specifically designed for cancer patients, may be an effective tool to deliver information and increase physical activity level in this population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signed informed consent;\n* confirmed cancer diagnosis.\n\nExclusion Criteria:\n\n\\- sufficient physical activity level.'}, 'identificationModule': {'nctId': 'NCT04213235', 'acronym': 'EDuCA', 'briefTitle': 'Educational Materials Development for Physical Activity in CAncer', 'organization': {'class': 'OTHER', 'fullName': 'Universita di Verona'}, 'officialTitle': 'E.D.u.CA: a Guidebook to Increase Physical Activity Level in Cancer Patients', 'orgStudyIdInfo': {'id': '67002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical exercise', 'interventionNames': ['Behavioral: Physical activity']}], 'interventions': [{'name': 'Physical activity', 'type': 'BEHAVIORAL', 'description': 'The participants will receive the written exercise guidebook and a counselling by kinesiologist. Moreover, they will be instructed how to increase their physical activity level.', 'armGroupLabels': ['Physical exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37131', 'city': 'Verona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alice Avancini', 'role': 'CONTACT', 'email': 'alice.avancini@univr.it', 'phone': '3403624264', 'phoneExt': '39'}], 'facility': 'University of Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}], 'centralContacts': [{'name': 'Alice Avancini', 'role': 'CONTACT', 'email': 'alice.avancini@univr.it', 'phone': '3403624264'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universita di Verona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Alice Avancini', 'investigatorAffiliation': 'Universita di Verona'}}}}