Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-31 @ 6:06 AM
Study NCT ID:
NCT06574256
Status:
COMPLETED
Last Update Posted:
2024-08-27
First Post:
2024-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Effects of Online Education Application on Gynecological Cancer Patients Receiving Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The universe of the study consisted of 114 women. The sample of the study consisted of 90 women. Inclusion Criteria for the Study Patients diagnosed with gynecological cancer and starting chemotherapy treatment for the first time in the hospital Speaking Turkish, having no communication problems Agreeing to participate in the study voluntarily Patients aged 18 and over Exclusion Criteria for the Study Illiterate Do not have a smart phone or computer Receiving radiotherapy together with chemotherapy Patients who do not know they have been diagnosed with cancer The intervention and control groups were randomized according to the literature; taking into account age group, education status, type and stage of gynecological cancer.\n\nWhen determining the intervention and control groups, patients who applied to the chemotherapy unit on Monday and Tuesday were included in the intervention group, and patients who applied on Wednesday and Thursday were included in the control group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-24', 'studyFirstSubmitDate': '2024-08-21', 'studyFirstSubmitQcDate': '2024-08-24', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EORT QLQ-C30', 'timeFrame': 'three monhts', 'description': 'EORT QLQ-C30: It consists of three main dimensions and 30 questions, namely general well-being, functional difficulties and symptom control.'}, {'measure': 'Nightingale symptom assessment scale', 'timeFrame': 'three monhts', 'description': 'Nightingale symptom assessment scale: This scale, consisting of 38 items, has three sub-dimensions, namely physical, social and psychological well-being.'}], 'secondaryOutcomes': [{'measure': 'European Organization for Research and Treatment of Cancer Quality of Life Questionnaire,', 'timeFrame': 'three monhts', 'description': 'EORT QLQ-C30: It consists of three main dimensions and 30 questions: general well-being, functional difficulties and symptom control. İThe first 28 questions are Likert-type. The other two questions are evaluated as 1: very bad and 7: excellent. Each subscale of the scale is scored between 0-100. High scores from the sub-dimension and general quality of life indicate that the quality of life is high, and high scores from the symptom scale indicate that the symptoms experienced are at a high level.'}, {'measure': 'Nightingale Symptom Assessment Scale', 'timeFrame': 'three months', 'description': 'Nightingale symptom assessment scale: This scale, consisting of 38 items, has three sub-dimensions: physical, social and psychological well-being. This is a Likert-type scale. The total sub-dimension score is calculated by adding the item scores in each sub-dimension and dividing by the number of items. 0-4 points are taken in each subscale of the scale. A high score indicates that the level of being affected by problems caused by the disease/treatment is high.'}, {'measure': 'patient satisfaction', 'timeFrame': 'one months', 'description': 'score average is taken.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gynecological cancer', 'symptom management', 'telenursing', 'quality of life', 'chemotherapy'], 'conditions': ['Gynecological Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of the study was to examine the effect of online nursing education given to women diagnosed with gynecological cancer and receiving chemotherapy. It was conducted as a randomized controlled experimental study. The study examined the effect of online nursing education given to patients in the intervention group diagnosed with gynecological cancer and receiving chemotherapy on symptoms, quality of life and patient satisfaction. The control group received routine nursing care.', 'detailedDescription': "This study examined the effect of online nursing education given to women diagnosed with gynecological cancer and receiving chemotherapy. This randomized controlled experimental study was conducted in a public hospital in Balıkesir province between December 1, 2021 and June 1, 2024. The study sample consisted of 90 women (intervention=45, control=45). Online nursing education was given to women in the intervention group receiving chemotherapy. Patients in the control group received routine nursing care. The study used the women's descriptive characteristics questionnaire, disease and treatment questionnaire, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Nightingale Symptom Assessment Scale, nurse follow-up form and patient satisfaction questionnaire. Data were collected during three chemotherapy cycles in four phases."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Patients diagnosed with gynecological cancer and receiving chemotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are diagnosed with gynecological cancer and who have started chemotherapy treatment for the first time in the hospital,\n\nhaving gynecological cancer\n\nreceiving chemotherapy\n\nSpeak Turkish, have no communication problems,\n\nAccept voluntarily to participate in the study,\n\nPatients who are 18 years of age or older\n\nExclusion Criteria:\n\n* Illiterate Patients who do not have a smart phone or computer Patients who receive radiotherapy together with chemotherapy Patients who do not know they have been diagnosed with cancer'}, 'identificationModule': {'nctId': 'NCT06574256', 'briefTitle': 'Investigation of the Effects of Online Education Application on Gynecological Cancer Patients Receiving Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Celal Bayar University'}, 'officialTitle': 'Investigation of the Effect of Online Nursing Education Given to Patients Diagnosed With Gynecological Cancer and Receiving Chemotherapy on Symptoms, Quality of Life and Patient Satisfaction', 'orgStudyIdInfo': {'id': 'CelalBayarU-LEE-ABK-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': "Patients in the intervention group will receive online nursing education and their quality of life and symptom complaints will be monitored by the nurse who provides education during three cycles of chemotherapy. At the end of the third cycle, patients' satisfaction with this education will be determined.", 'interventionNames': ['Other: Chemotherapy symptom Management Online Education']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'Patients in the control group will receive routine nursing care. Patients in the control group will be monitored for quality of life and symptom complaints during three cycles of chemotherapy.'}], 'interventions': [{'name': 'Chemotherapy symptom Management Online Education', 'type': 'OTHER', 'otherNames': ['Chemotherapy symptom Management', 'nursing online education'], 'description': 'Randomization was achieved and data collection began. Patients were given the "Chemotherapy Symptom Management Education Booklet" and were informed that they would be contacted by phone.\n\nIn the second and third stages of data collection, they were called by phone on the 7th day after receiving chemotherapy treatment. The symptoms experienced by the patient were evaluated with the N-SDS and the quality of life was evaluated with the EORTC QLQ-C30. Online nursing education videos were sent to the women in the intervention group regarding the symptoms they experienced. The practices they performed from the suggestions in the education videos and education booklets sent were recorded on the nurse follow-up form.\n\nIn the fourth stage, the practices specified in the third stage were repeated on the 7th day after the third chemotherapy course, and at this stage, the satisfaction of the women in the intervention group with the online education was evaluated.', 'armGroupLabels': ['intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45010', 'city': 'Manisa', 'country': 'Turkey (Türkiye)', 'facility': 'CelalBayarU', 'geoPoint': {'lat': 38.61202, 'lon': 27.42647}}], 'overallOfficials': [{'name': 'ayşegül beyazpınar kavaklıoğlu, student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Celal Bayar University'}, {'name': 'emre yanıkkerem, prof.dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Celal Bayar University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celal Bayar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'yşegül Beyazpınar KAVAKLIOĞLU', 'investigatorAffiliation': 'Celal Bayar University'}}}}