Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT05344820
Status:
UNKNOWN
Last Update Posted:
2022-06-22
First Post:
2022-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of the Art-based Mandala Intervention on the Quality of Life of Cancer Patients Receiving Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D000079562', 'term': 'Rumination Syndrome'}, {'id': 'D000342', 'term': 'Affective Symptoms'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-19', 'studyFirstSubmitDate': '2022-04-18', 'studyFirstSubmitQcDate': '2022-04-18', 'lastUpdatePostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'level of quality of life', 'timeFrame': '1 week', 'description': 'Level of quality of life as assessed by the Quality of Life Scale for the Treatment and Research of Cancer (min:0, max:100,with higher values indicating a higher functioning in functional scales and an increased presence of symptoms in symptom scales)'}, {'measure': 'level of fatigue', 'timeFrame': '1 week', 'description': 'level of fatigue assessed by the Piper Fatigue Scale (min:0, max, 100, higher values means higher fatigue)'}], 'secondaryOutcomes': [{'measure': 'level of alexithymia', 'timeFrame': '1 week', 'description': 'level of alexithymia assessed by Toronto Alexythimia Scale (higher values means more alexithymic)'}, {'measure': 'level of rumination', 'timeFrame': '1 week', 'description': 'level of rumination assessed by ruminative thought scale (higher values means more ruminative thought)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer', 'Chemotherapy Effect', 'Fatigue', 'Quality of Life', 'Rumination', 'Alexithymia'], 'conditions': ['Cancer', 'Chemotherapy Effect', 'Fatigue', 'Quality of Life', 'Rumination', 'Alexithymia']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the effect of mandala application on fatigue, quality of life, rumination and alexithymia in cancer patients receiving chemotherapy.', 'detailedDescription': 'A randomized controlled study on the effect of mandala application on cancer related fatigue, quality of life, rumination and alexithymia in cancer patients receiving chemotherapy has not been found in the literature.\n\nThe aim of this study is to determine the effect of mandala application on fatigue, quality of life, rumination and alexithymia in cancer patients receiving chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Conscious and no communication problems\n* Being literate\n* Having a cancer diagnosis\n* Receiving chemotherapy treatment (planned to continue treatment for 8 more weeks)\n* Willing to participate in our study voluntarily\n\nExclusion Criteria:\n\n* Not being willing to participate in the research\n* Desire to leave the study at any time\n* Deterioration of compliance with the working criteria during the time of the study,\n* Those who do not participate in up to four mandala applications during the study period\n* Those who cannot use a pen\n* Those with a diagnosis of psychiatric and neurological disease\n* Patients who are scheduled for drug intervention, radiotherapy, surgery other than chemotherapy within 8 weeks'}, 'identificationModule': {'nctId': 'NCT05344820', 'acronym': 'ARQULA', 'briefTitle': 'The Effect of the Art-based Mandala Intervention on the Quality of Life of Cancer Patients Receiving Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey'}, 'officialTitle': 'The Effect of the Art-based Mandala Intervention on the Quality of Life of Cancer Patients Receiving Chemotherapy', 'orgStudyIdInfo': {'id': 'ARQULA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mandala Intervention', 'description': 'To the experimental group; Mandala practice will be done for 2 hours, once a week for 8 weeks.', 'interventionNames': ['Behavioral: Art based mandala']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention will be applied to the control group'}], 'interventions': [{'name': 'Art based mandala', 'type': 'BEHAVIORAL', 'description': 'To the experimental group; Mandala practice will be done for 2 hours, once a week for 8 weeks.', 'armGroupLabels': ['Mandala Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34660', 'city': 'Üsküdar', 'state': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Elif Yıldırım Ayaz, M.D.', 'role': 'CONTACT', 'email': 'drelifyildirim@hotmail.com', 'phone': '05325148300'}], 'facility': 'Sultan Abdülhamid Training and Research Hospital', 'geoPoint': {'lat': 41.02274, 'lon': 29.01366}}], 'centralContacts': [{'name': 'Elif Yıldırım Ayaz, M.D.', 'role': 'CONTACT', 'email': 'drelifyildirim@hotmail.com', 'phone': '+905325148300'}], 'overallOfficials': [{'name': 'Elif Yıldırım Ayaz, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sultan Abdülhamid Training And Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Elif Yıldırım Ayaz', 'investigatorAffiliation': 'Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey'}}}}