Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-01-02 @ 12:23 AM
Study NCT ID:
NCT04600869
Status:
COMPLETED
Last Update Posted:
2020-10-23
First Post:
2020-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Naturalistic Decision-Making Model-based Oncofertility Care Education
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This study examined the effects of an oncofertility education program on decisional conflict in nurses caring for breast cancer patients and patients with breast cancer.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-21', 'studyFirstSubmitDate': '2020-10-16', 'studyFirstSubmitQcDate': '2020-10-21', 'lastUpdatePostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decisional conflict', 'timeFrame': 'Nurses: 1 month; Patients: 6 months', 'description': 'The decisional conflict was measured using the Chinese version of the decisional conflict scale. Each item was rated on a five-point Likert scale, ranging from zero to 4. The score was calculated by averaging the sum of individual item scores, then multiplying the product by 25. Hence, the scores range from 0 to 100. A higher score indicates higher decisional conflict. Both nursing and patient participants were asked to fill out the questionnaire.'}, {'measure': 'Oncofertility Barrier Scale', 'timeFrame': 'Nurses: 1 month', 'description': "An Oncofertility Barrier Scale was developed to assess nurses' perceptions of comprehensive barriers regarding oncofertility care. The responses to each item were provided using a five-point Likert scale. A higher scale score meant the nurses perceived that it was more difficult to provide oncofertility care."}, {'measure': 'Infertility Knowledge Questionnaire', 'timeFrame': 'Nurses: 1 month; Patients: 6 months', 'description': "We used the Infertility Knowledge Questionnaire to measure both of nurses' and patients' knowledge of infertility in patients with breast cancer. Total scores for the 11 items ranged from zero to 11. Centimeters were used to show the ratio of correct answers visually. A higher score meant a greater level of knowledge about infertility. Both nursing and patient participants were asked to fill out the questionnaire."}], 'secondaryOutcomes': [{'measure': 'Fertility Intention Scale', 'timeFrame': 'Patients: 6 months', 'description': "The Fertility Intention Scale with 15 items was used to measure patients' fertility intentions. The standardized scale ranged from 1 to 5 points on a five-point Likert scale. Higher scores indicated a greater degree of fertility intention."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Education', 'Decisional Conflict', 'Breast Cancer', 'Nurse', 'Oncofertility'], 'conditions': ['Fertility Issues', 'Breast Cancer', 'Education']}, 'referencesModule': {'references': [{'pmid': '35835904', 'type': 'DERIVED', 'citation': 'Huang SM, Tseng LM, Lien PJ. Effects of naturalistic decision-making model-based oncofertility care education for nurses and patients with breast cancer: a cluster randomized controlled trial. Support Care Cancer. 2022 Oct;30(10):8313-8322. doi: 10.1007/s00520-022-07279-w. Epub 2022 Jul 15.'}]}, 'descriptionModule': {'briefSummary': 'his study examined the effects of an oncofertility education program on decisional conflict in nurses caring for breast cancer patients and patients with breast cancer. Other predictors of decisional conflict were also examined.', 'detailedDescription': "Background: Nurses play an essential role in transferring knowledge to patients. However, several factors cause nurses to adopt a negative attitude toward providing oncofertility care.\n\nObjective: This study examined the effects of an oncofertility education program on decisional conflict in nurses caring for breast cancer patients and patients with breast cancer. Other predictors of decisional conflict were also examined.\n\nDesign: Randomized, controlled experimental research. Settings and Participants: Patients (61) with breast cancer and nurses (79) were recruited from a hospital in Taipei, Taiwan.\n\nMethods: The nursing participants were randomly assigned to receive oncofertility education (experimental group) or usual education (control group). Data from female patients in the control and experimental groups were collected before and after the nurses' educational training, respectively. The oncofertility education consisted of one face-to-face educational session and reading one educational booklet based on the Naturalistic Decision-Making (NDM) Model. The decisional conflict was measured using the Chinese version of the decisional conflict scale."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All nurses involved in breast care were recruited into the study.\n* Female patients with breast cancer who were younger than 50 years and who were about to start cancer treatment were recruited from one teaching hospital in Taipei, Taiwan.\n\nExclusion Criteria:\n\n* Women with a major illness or mental disorder before their cancer diagnosis were excluded.'}, 'identificationModule': {'nctId': 'NCT04600869', 'briefTitle': 'Effects of Naturalistic Decision-Making Model-based Oncofertility Care Education', 'organization': {'class': 'OTHER', 'fullName': 'Mackay Medical College'}, 'officialTitle': 'Effects of Naturalistic Decision-Making Model-based Oncofertility Care Education for Nurses and Patients With Breast Cancer', 'orgStudyIdInfo': {'id': 'HSM/VGH-2017-01-011AC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nursing Group', 'description': 'Nurses in the control group accepted the other non-fertility (standard) nursing training for the intervention, whereas those in the experimental group accepted the oncofertility training. Based on research ethics and design, a standard education course was held for the control group after completing data collection in the nursing experimental group. We began to recruit patients into the patient experimental group after all nurses completed their educational courses.', 'interventionNames': ['Other: Naturalistic Decision-Making Model-based Oncofertility Care Education']}], 'interventions': [{'name': 'Naturalistic Decision-Making Model-based Oncofertility Care Education', 'type': 'OTHER', 'description': "We designed the education program according to Klein's NDM model, which explored the reasoning mechanism behind decision-making (Klein, 1993). It depends on the on-the-job training date in each unit. The education program consisted of the following: (1) Information accumulation: explanations of common cancer therapies related to subsequent infertility, psychological and mental change in cancer survivors with infertility, the necessity and method of early determination of fertility intention, and type of fertility preservation. (2) Sense-making: situational case sharing, emphasis on the guidance interaction between experienced and novice nurses to understand the patient's situation. (3) Decision-making: how to provide support, how to correspond, and attitudes toward people with strong fertility intention.", 'armGroupLabels': ['Nursing Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'New Taipei City', 'country': 'Taiwan', 'facility': 'Department of Nursing', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}], 'overallOfficials': [{'name': 'Sheng-Miauh Huang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nursing, Mackay Medical College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mackay Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'the Office of Research and Development', 'investigatorFullName': 'Chin-Tsung Shen', 'investigatorAffiliation': 'Mackay Medical College'}}}}