Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-27 @ 1:10 AM
Study NCT ID:
NCT05977504
Status:
UNKNOWN
Last Update Posted:
2023-08-07
First Post:
2023-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of "Multi-Psychological Empowerment" Courses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003142', 'term': 'Communication'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-03', 'studyFirstSubmitDate': '2023-07-03', 'studyFirstSubmitQcDate': '2023-07-26', 'lastUpdatePostDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in Physical and Psychological Symptoms', 'timeFrame': '5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks；Time 4:12th weeks；Time 5(back to work 1 month)', 'description': "The change in oncology nurses' physical and psychological state will be measured by physical and psychological state survey. It use Numerical Rating Scale(VRS) 0-10. It is a 11 Point Likert Scale (e. g. 0 is no pain; 10 is unbearable pain)."}, {'measure': 'The change in Workload', 'timeFrame': '5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks；Time 4:12th weeks；Time 5(back to work 1 month)', 'description': "The change in oncology nurses' workload will be measured by the self-designed scale using VRS (Numerical Rating Scale). It measures the subjective perception of oncology nurses about their workload in the past week, with scores ranging from 0 to 10.The higher the score, the greater the workload of the oncology nurses."}], 'secondaryOutcomes': [{'measure': 'Self efficacy scale (GSES)', 'timeFrame': '5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks；Time 4:12th weeks；Time 5(back to work 1 month)', 'description': "Oncology nurses' self-efficacy were measured by self efficacy scale. There are 10 questions about the level of confidence in these situations. It's a 4 point (1-4),higher the score means the more confident you have. There is also 11 point (0-10) scale that higher the score means the more confident you are in caring for patients."}, {'measure': 'Communication ability scale', 'timeFrame': '5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks；Time 4:12th weeks；Time 5(back to work 1 month)', 'description': "Oncology nurses' communication skills were measured by communication ability scale.It is a 5 Liker scale(1-5),higher scores represent better communication skills."}, {'measure': 'Efferson Empathy Scale', 'timeFrame': '5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks；Time 4:12th weeks；Time 5(back to work 1 month)', 'description': "Oncology nurses' empathy were measured by Efferson Empathy Scale. It is a 7 Liker scale(1-7),higher scores means someone have more empathy."}, {'measure': 'Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being （FACIT-Sp）', 'timeFrame': '5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks；Time 4:12th weeks；Time 5(back to work 1 month)', 'description': "Oncology nurses' spiritual well-being were measured by FACIT-Sp.It is a 5 Liker scale(0-4),higher scores represent better well-being."}, {'measure': 'Burnout Inventory survey', 'timeFrame': '5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks；Time 4:12th weeks；Time 5(back to work 1 month)', 'description': "Oncology nurses' burnout will be measured by Burnout Inventory survey.It is a 7 Liker scale(0-6),higher scores represent high level burnout ."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Training course', 'Oncology nurse', 'Psychological support', 'Self-efficacy'], 'conditions': ['Cancer', 'Oncology', 'Psychological', 'Self Efficacy', 'Communication']}, 'descriptionModule': {'briefSummary': 'In the first-year project of this study, oncology nurses have reported experiencing massive stress, insufficient communication ability, and the need for communication-related training. 70% of them had moderate or higher severity of workload, fatigue, and psychological distress (at the measure point) before being provided with Basic Remote Psychological Support Course (BRPSC). A month after BRPSC, some oncology nurses have indicated/affirmed the benefits of undergoing the comprehensive psycho oncology education training courses. Thus, the second- and third-year continuation projects are focused on the development and delivery of Multi-Psychological Empowerment Courses (MPEC) for oncology nurses'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Intervention group\n\n* Inclusion Criteria:\n* Over 20 years old (inclusive)\n* Oncology nurses currently working in clinical practice\n* At least receiving one course related to oncology nurse training, such as chemotherapy for nursing staff or oncology advanced training courses.\n* Exclusion Criteria:\n* Those who are unwilling or unable to participate in this course training for a full one- year period.\n\nControl group Oncology nurses who do not need to be recruited for the comparison group will be students who participated in the remote psychological support course of the first year project effective comparison groups.'}, 'identificationModule': {'nctId': 'NCT05977504', 'briefTitle': 'The Effectiveness of "Multi-Psychological Empowerment" Courses', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Effectiveness of "Multi-Psychological Empowerment" Courses Through Remote, Digital Media, Workshop Intervention for Oncology Nurses on Physical and Psychological Status, Self-Efficacy and Communication Ability', 'orgStudyIdInfo': {'id': '202302085RINC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multi-Psychological Empowerment Courses', 'description': '9 times online course and 3-days workshop for 6 months .', 'interventionNames': ['Other: Multi-Psychological Empowerment Courses']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Participants in control group will receive usual course.'}], 'interventions': [{'name': 'Multi-Psychological Empowerment Courses', 'type': 'OTHER', 'description': '9 times online course and 3-days workshop for 6 months of psychological Empowerment Courses.', 'armGroupLabels': ['Multi-Psychological Empowerment Courses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '802', 'city': 'Taipei', 'country': 'Taiwan', 'contacts': [{'name': 'Yun Hsiang Lee, PhD', 'role': 'CONTACT', 'email': 'yhlee338@ntu.edu.tw', 'phone': '886 2 23123456', 'phoneExt': '88424'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Yun Hsiang Lee, PhD', 'role': 'CONTACT', 'email': 'yhlee338@ntu.edu.tw', 'phone': '886 2 23123456', 'phoneExt': '88424'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}