Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-05 @ 6:27 PM
Study NCT ID:
NCT02380469
Status:
COMPLETED
Last Update Posted:
2019-01-22
First Post:
2015-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improvement of Information to Cancer Patients' Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-18', 'studyFirstSubmitDate': '2015-01-29', 'studyFirstSubmitQcDate': '2015-03-02', 'lastUpdatePostDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The time spent on information as reported by health care professionals', 'timeFrame': 'Weeks 0-6 from baseline', 'description': 'Investigated in focus group interviews with the health care professionals'}, {'measure': 'Satisfaction with information from health care professionals', 'timeFrame': 'Change from baseline (enrollment) at 12 weeks', 'description': 'Measure: CaTCoN item 24'}, {'measure': 'Satisfaction with information from health care professionals', 'timeFrame': 'Change from baseline (enrollment) at 12 weeks', 'description': 'Measure: CaTCoN subscale "Lack of information from health care professionals" (revised version)'}, {'measure': 'Satisfaction with communication with health care professionals', 'timeFrame': 'Change from baseline (enrollment) at 12 weeks', 'description': 'Measure: CaTCoN subscale "Problems with the quality of information and communication from health care professionals"'}, {'measure': 'Satisfaction with support from health care professionals', 'timeFrame': 'Change from baseline (enrollment) at 12 weeks', 'description': 'Measures: CaTCoN subscale "Lack of attention from health care professionals on the caregivers\' wellbeing"'}, {'measure': 'Satisfaction with support from health care professionals', 'timeFrame': 'Change from baseline (enrollment) at 12 weeks', 'description': 'Measures: CaTCoN subscale "Need for help from health care professionals"'}, {'measure': 'Anxiety and depression', 'timeFrame': 'Change from baseline (enrollment) at 12 weeks', 'description': 'Measure: The Hospital Anxiety and Depression Scale (HADS)'}, {'measure': 'Fulfillment of needs', 'timeFrame': 'Change from baseline (enrollment) at 12 weeks', 'description': 'Measure: Family Inventory of Needs (FIN)'}], 'primaryOutcomes': [{'measure': 'Satisfaction with information from health care professionals', 'timeFrame': 'Change from baseline (enrollment) at 2 weeks', 'description': 'Measure: The "Cancer Caregiving Tasks, Consequences and Needs Questionnaire" (CaTCoN) item 24'}], 'secondaryOutcomes': [{'measure': 'Satisfaction with information from health care professionals', 'timeFrame': 'Change from baseline (enrollment) at 2 weeks', 'description': 'Measure: CaTCoN subscale "Lack of information from health care professionals" (revised version)'}, {'measure': 'Satisfaction with communication with health care professionals', 'timeFrame': 'Change from baseline (enrollment) at 2 weeks', 'description': 'Measure: CaTCoN subscale "Problems with the quality of information and communication from health care professionals"'}, {'measure': 'Satisfaction with support from health care professionals', 'timeFrame': 'Change from baseline (enrollment) at 2 weeks', 'description': 'Measures: CaTCoN subscale "Lack of attention from health care professionals on the caregivers\' wellbeing"'}, {'measure': 'Satisfaction with support from health care professionals', 'timeFrame': 'Change from baseline (enrollment) at 2 weeks', 'description': 'Measures: CaTCoN subscale "Need for help from health care professionals"'}, {'measure': 'Anxiety and depression', 'timeFrame': 'Change from baseline (enrollment) at 2 weeks', 'description': 'Measure: The Hospital Anxiety and Depression Scale (HADS)'}, {'measure': 'Fulfillment of needs', 'timeFrame': 'Change from baseline (enrollment) at 2 weeks', 'description': 'Measure: Family Inventory of Needs (FIN)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Caregivers', 'Cancer', 'Information', 'Intervention', 'Randomised trial'], 'conditions': ['Neoplasms']}, 'referencesModule': {'references': [{'pmid': '22564144', 'type': 'BACKGROUND', 'citation': "Lund L, Ross L, Groenvold M. The initial development of the 'Cancer Caregiving Tasks, Consequences and Needs Questionnaire' (CaTCoN). Acta Oncol. 2012 Nov;51(8):1009-19. doi: 10.3109/0284186X.2012.681697. Epub 2012 May 8."}, {'pmid': '24628263', 'type': 'BACKGROUND', 'citation': "Lund L, Ross L, Petersen MA, Groenvold M. The validity and reliability of the 'Cancer Caregiving Tasks, Consequences and Needs Questionnaire' (CaTCoN). Acta Oncol. 2014 Jul;53(7):966-74. doi: 10.3109/0284186X.2014.888496. Epub 2014 Mar 16."}, {'pmid': '25432867', 'type': 'BACKGROUND', 'citation': "Lund L, Ross L, Petersen MA, Groenvold M. The interaction between informal cancer caregivers and health care professionals: a survey of caregivers' experiences of problems and unmet needs. Support Care Cancer. 2015 Jun;23(6):1719-33. doi: 10.1007/s00520-014-2529-0. Epub 2014 Nov 29."}, {'pmid': '31177391', 'type': 'DERIVED', 'citation': 'Lund L, Ross L, Petersen MA, Sengelov L, Groenvold M. Improving information to caregivers of cancer patients: the Herlev Hospital Empowerment of Relatives through More and Earlier information Supply (HERMES) randomized controlled trial. Support Care Cancer. 2020 Feb;28(2):939-950. doi: 10.1007/s00520-019-04900-3. Epub 2019 Jun 8.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to investigate whether a systematic early assessment of uncovered needs for information, supplemented by an interview about the needs with the patient's nurse who seeks to provide the information requested, will improve the caregivers' and the patients' satisfaction with information and communication and potentially also decrease anxiety and depression."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Patient Inclusion Criteria:\n\n* Cancer patient\n* Newly refered to (i.e., this is the patient's first visit in) Department of Oncology, Herlev Hospital, in order to start medical treatment (e.g. chemotherapy)\n* Written informed consent\n\nCaregiver Inclusion Criteria:\n\n* Attends the first visit in the Department of Oncology with the patient\n* Has lacked information about at least one of the 13 aspects of information asked about in the questionnaire\n* Written informed consent\n\nExclusion Criteria:\n\n* Patient and/or caregiver do not understand Danish well enough to participate in the study\n* The patient has an expected survival of less than six months"}, 'identificationModule': {'nctId': 'NCT02380469', 'briefTitle': "Improvement of Information to Cancer Patients' Caregivers", 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': "Improvement of Information to Cancer Patients' Caregivers: a Randomised Intervention Study", 'orgStudyIdInfo': {'id': 'R82-A5445'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate intervention', 'description': 'Immediately after enrollment in the project, caregivers and patients receive the intervention', 'interventionNames': ['Behavioral: Identification and provision of lacking information']}, {'type': 'OTHER', 'label': 'Delayed intervention (3 weeks later)', 'description': 'This group receives the same intervention as in the experimental group, but after the outcome assessment at 2 weeks', 'interventionNames': ['Behavioral: Identification and provision of lacking information']}], 'interventions': [{'name': 'Identification and provision of lacking information', 'type': 'BEHAVIORAL', 'description': "The intervention consists of an interview about the caregiver's responses (baseline measurement) to a list about 'lack of information' within 13 areas. For each area, the patient's nurse will enquire about what information is requested by the caregiver and the patient. Subsequently, the nurse provides the requested information. She may involve the doctor and arrange follow-up visits or phone calls until the need is covered", 'armGroupLabels': ['Delayed intervention (3 weeks later)', 'Immediate intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Department of Oncology, Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'overallOfficials': [{'name': 'Mogens Groenvold, DMSc PhD MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bispebjerg Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danish Cancer Society', 'class': 'OTHER'}, {'name': 'Herlev Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, DMSc, PhD, MD', 'investigatorFullName': 'Mogens Groenvold', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}