Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-06-23 @ 11:31 PM
Study NCT ID:
NCT04822220
Status:
COMPLETED
Last Update Posted:
2024-01-09
First Post:
2021-03-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Self-Management Program Based on the Individual and Family Self-management Theory on Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomized controlled trial consisting of two groups: experimental and control.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-06', 'studyFirstSubmitDate': '2021-03-26', 'studyFirstSubmitQcDate': '2021-03-26', 'lastUpdatePostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in fatigue on the Brief Fatigue Inventory at week 8', 'timeFrame': 'Baseline, 2 week, 4 week, 8 week', 'description': 'The Brief Fatigue Inventory is a validated, self reported instrument assessing average fatigue.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in daily living activities on the Katz Index of Independence at week 8', 'timeFrame': 'Baseline, 2 week, 4 week, 8 week', 'description': 'The Katz Index of Independence is a validated, self reported instrument assessing average daily living activities.'}, {'measure': 'Change From Baseline in well-being on Well-Being Questionnaire (22 items) (W-BQ22) at week 8', 'timeFrame': 'Baseline, 2 week, 4 week, 8 week', 'description': 'Well-Being Questionnaire (22 items) (W-BQ22) is a validated, self reported instrument assessing average well-being.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nursing', 'cancer patients', 'self-management', 'fatigue', 'activities of daily living', 'well-being', 'randomized controlled trial'], 'conditions': ['Oncology', 'Fatigue', 'Patient']}, 'referencesModule': {'references': [{'pmid': '38417400', 'type': 'DERIVED', 'citation': 'Karakus Z, Ozer Z. The effect of a fatigue self-management program based on individual and family self-management theory in cancer patients: A single-blinded randomized controlled trial. Eur J Oncol Nurs. 2024 Apr;69:102483. doi: 10.1016/j.ejon.2023.102483. Epub 2023 Dec 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of Self-Management Program based on the Individual and Family Self-management Theory on fatigue, daily living activities and well-being of cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inpatients for symptom management or supportive care in oncology wards\n* Patients who were at first two days of hospitalization\n* Patients who had score of 3≤ or ≤7 in Fatigue Visual Analogue Scale (VAS)\n* Patients who had score of ≤5 in Pain Analog Visual Scale (VAS)\n* Patients who had score of ≤5 The Modified Borg Scale\n* Patients who had score of 0, 1, 2 or 3 in ECOG Performance scale\n* Patients who had metastases\n* Patients who were over 18 years of age\n* Patients who had orientation of person, place and time\n* Patients who had no communication barriers\n* Patients who agreed to participate in the study\n\nExclusion Criteria:\n\n* Patients who had hospitalized for the purpose of receiving chemotherapy\n* Patients whose Hb value was ≤8 g / dl\n* Patients whose body temperature ≥ 38.5 ° C within the last 24 hours\n* Patients who had diarrhea in the last 24 hours (frequency of defecation ≥ 3 / day)\n* Patients who had a score of ≤ 16 kg / m2 in Body Mass Index (BMI)\n* Patients who had advanced heart failure\n* Patients who had untreated hypothyroidism\n* Patients who diagnosed with major depression and / or treated for depression\n* Patients who had no family member involved in their care'}, 'identificationModule': {'nctId': 'NCT04822220', 'briefTitle': 'The Effect of Self-Management Program Based on the Individual and Family Self-management Theory on Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Akdeniz University'}, 'officialTitle': 'The Effect of Self-Management Program Based on the Individual and Family Self-management Theory on Fatigue, Daily Life Activities and Wellness on Cancer Patients', 'orgStudyIdInfo': {'id': '0002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Fatigue Self-management Programme', 'interventionNames': ['Other: Fatigue Self-management Programme']}, {'type': 'NO_INTERVENTION', 'label': 'Controlled', 'description': 'The control group received routine treatment and nursing care'}], 'interventions': [{'name': 'Fatigue Self-management Programme', 'type': 'OTHER', 'description': 'Fatigue Self-management Programme', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07058', 'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Zeynep Karakuş', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}], 'overallOfficials': [{'name': 'Zeynep Özer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Akdeniz University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akdeniz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Zeynep KARAKUŞ', 'investigatorAffiliation': 'Akdeniz University'}}}}