Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-30 @ 4:38 PM
Study NCT ID:
NCT04839835
Status:
UNKNOWN
Last Update Posted:
2021-04-09
First Post:
2021-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anxiety on the First Day of Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-03-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-07', 'studyFirstSubmitDate': '2021-04-07', 'studyFirstSubmitQcDate': '2021-04-07', 'lastUpdatePostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anxiety and stress measurements', 'timeFrame': '60-120 minutes', 'description': 'The State-Trait Anxiety Inventory (STAI) - Measuring anxiety with the Hospital Anxiety and Depression Scale (HADS)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'investigating chemotherapy anxieties', 'detailedDescription': 'Breast cancer is the most common type of cancer in women in the world, and it is the first in cancer-related deaths in women all over the world. In the treatment of breast cancer, in addition to surgery, patients with advanced stage or high risk of recurrence receive neoadjuvant and adjuvant chemotherapy treatments. This period starts with 3 months and extends according to the treatment protocols it will receive.\n\nSince the first diagnosis of breast cancer, it has psychological effects such as intense stress, decrease in quality of life and anxiety as well as physical effects on patients. The time spent in the "waiting room" while patients are examined and receiving treatment before chemotherapy inevitably has an effect on their anxiety.\n\nIn this study; It was aimed to investigate the effects of environmental factors in waiting rooms on patients\' anxiety.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* to receive chemotherapy for breast cancer for the first time\n* give consent for the study\n\nExclusion Criteria:\n\n* not approving to participate in the study'}, 'identificationModule': {'nctId': 'NCT04839835', 'briefTitle': 'Anxiety on the First Day of Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Namik Kemal University'}, 'officialTitle': 'The Effect of Art Design in the Chemotherapy Waiting Room on the Anxiety of Patients Who Will Receive Chemotherapy for the First Time', 'orgStudyIdInfo': {'id': 'waitingroom'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'standard waiting room', 'description': 'standard chemoterapy waiting room'}, {'type': 'EXPERIMENTAL', 'label': 'waiting room enriched with art objects', 'description': 'waiting room enriched with music, paintings and artificial plants', 'interventionNames': ['Other: waiting room enriched with music, paintings and artificial plants']}], 'interventions': [{'name': 'waiting room enriched with music, paintings and artificial plants', 'type': 'OTHER', 'description': 'waiting room enriched with music, paintings and artificial plants', 'armGroupLabels': ['waiting room enriched with art objects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59100', 'city': 'Tekirdağ', 'country': 'Turkey (Türkiye)', 'facility': 'Tekirdağ Namık Kemal ÜNiversitesi', 'geoPoint': {'lat': 40.9781, 'lon': 27.51101}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Namik Kemal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asoc. Prof.', 'investigatorFullName': 'Asoc. Prof. Erdoğan Selçuk Şeber', 'investigatorAffiliation': 'Namik Kemal University'}}}}