Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-31 @ 11:28 AM
Study NCT ID:
NCT00927433
Status:
UNKNOWN
Last Update Posted:
2011-06-30
First Post:
2009-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cancer Patients' Knowledge About Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'D018479', 'term': 'Early Intervention, Educational'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-29', 'studyFirstSubmitDate': '2009-06-23', 'studyFirstSubmitQcDate': '2009-06-24', 'lastUpdatePostDateStruct': {'date': '2011-06-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of fatigue', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fatigue', 'Cancer', 'Radiation therapy', 'Chemotherapy', 'Hormones', 'Surgery', 'Breast cancer'], 'conditions': ['Cancer', 'Fatigue']}, 'descriptionModule': {'briefSummary': 'Background: Result from an earlier study I carried out in the late 1990 showed that cancer patients were overall well informed about diagnoses, prognoses, symptoms, treatment, side-effects of treatment e.g. pain, nausea and vomiting and hair loss. Their knowledge about fatigue as a side -effect to cancer and cancer treatment was however different. Patients had minimal knowledge about fatigue and they were not prepared for this side-effect and as a result of this they did not know how to handle fatigue and fatigue was seen as a very frightening experience.\n\nAs a result of the findings I wanted to carry out an intervention study, where the aims were to develop an educational programme about fatigue and to evaluate the effect of the programme.\n\nPurpose: The purpose of the project is to develop and describe a structured educational programme. The structured educational programme will serve as the intervention. The purpose is also to evaluate whether or not the structured educational programme increase the cancer patients knowledge about cancer related fatigue and to find out if increased knowledge about cancer related fatigue ease the experience of cancer related fatigue.\n\nAnother purpose of the study is to investigate the connection between fatigue and other symptoms and to find out how other symptoms influence the patients experience of fatigue.\n\nThe study will consist of 3 stages.\n\n* Development of structured educational programme\n* Implementation of structured educational programme\n* Evaluation of the effect of the structured educational programme\n\nMaterials and methods: The study is a randomised experimental design. An intervention group and a control group, each consisting of 100 Breast Cancer patients (Stadium I or II) receiving chemotherapy or/and radiation therapy after surgery are included in the study. On a NR-scale (0-10) the patients had a fatigue score of 2,5 or more to be included in the study.\n\nThe intervention is an educational package of 120 minutes x 3 over three weeks. The intervention is given in groups of 10 patients. Both groups are responding to questionnaires just before the intervention, just after the intervention and three months after finishing the intervention. The educational package consisted of basic knowledge about fatigue, and strategies or techniques for coping with fatigue.'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with breast cancer stage I or II.\n* Fatigue score more than 2.5 on a NRS (O-10).\n* Give written consent.\n\nExclusion Criteria:\n\n* Under the age of 10 years,\n* Not able to read, write or understand Norwegian.'}, 'identificationModule': {'nctId': 'NCT00927433', 'briefTitle': "Cancer Patients' Knowledge About Fatigue", 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Development and Implementation of a Structured Educational Programme to Increase Patients Knowledge About Fatigue and to Evaluate the Effect of Increased Knowledge on Cancer Patients Experience of Fatigue', 'orgStudyIdInfo': {'id': 'Intervention, cancer fatigue'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard care', 'description': 'Patients received standard education about fatigue by clinicians.', 'interventionNames': ['Behavioral: Psychoeducational intervention for cancer-related fatigue']}, {'type': 'EXPERIMENTAL', 'label': 'Education arm', 'description': 'Patients received education on fatigue management in groups of ten patients over two weeks in three two hour sessions.', 'interventionNames': ['Behavioral: Psychoeducational intervention for cancer-related fatigue']}], 'interventions': [{'name': 'Psychoeducational intervention for cancer-related fatigue', 'type': 'BEHAVIORAL', 'otherNames': ['Standard care', 'Educational intervention'], 'description': 'Patients received education on fatigue management in groups of ten patients over two weeks in three two hour sessions', 'armGroupLabels': ['Education arm', 'Standard care']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Tone Rustøen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Tone Rustøen', 'oldOrganization': 'Rikshospitalet HF'}}}}