Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-31 @ 10:29 PM
Study NCT ID:
NCT01060761
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2010-02-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Involvement of Patients and Relatives in the Course of Cancer Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-02', 'studyFirstSubmitDate': '2010-02-01', 'studyFirstSubmitQcDate': '2010-02-01', 'lastUpdatePostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life,', 'timeFrame': 'two months and one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cancer', 'Rehabilitation program (patient and a relative together)', 'counselling', 'retreat weekend'], 'conditions': ['Rehabilitation', 'Cancer', 'Relatives']}, 'descriptionModule': {'briefSummary': 'The objective is to investigate a rehabilitation program (supportive conversations and a rehabilitation course for cancer patients and their relatives together).\n\nThe study evaluate the effect of the program compared to no intervention (usual care)', 'detailedDescription': 'The study aim to evaluate the effect and the benefit of the program.\n\nFirst the patients psychosocial well-being is assessed in a survey (EORTC, POMS, WHO-5 well-being index) Then their relatives psychosocial well-being is assessed in a survey (Ad hoc questions, POMS and WHO-5 well-being index)\n\nThe effect is also assessed in qualitative interviews with patients and their relatives.\n\nThe rehabilitation course is investigated in qualitative observations and interviews.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both the patient and their relative must agree to participate together\n* Patient admitted to the Hospital\n* Patient admitted with a lung cancer diagnosis or\n* Patient admitted with a gynecological cancer diagnosis\n\nExclusion Criteria:\n\n* The cancer diagnosis was not verified.'}, 'identificationModule': {'nctId': 'NCT01060761', 'acronym': 'KRIPP', 'briefTitle': 'Involvement of Patients and Relatives in the Course of Cancer Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'Involvement of Patients and Relatives in the Course of Cancer Disease With a Particular View to Rehabilitation and the Life With Cancer', 'orgStudyIdInfo': {'id': 'HMS-SDU- 2009-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Rehabilitation program', 'description': 'Counselling (supportive conversation with patient and their relatives together) Retreat Weekend (patient and their relatives together)', 'interventionNames': ['Behavioral: Rehabilitation program']}, {'type': 'NO_INTERVENTION', 'label': 'Ususal treatment and support', 'description': 'Usual support and treatment at the hospital, no retreat Weekend.'}], 'interventions': [{'name': 'Rehabilitation program', 'type': 'BEHAVIORAL', 'otherNames': ['KRIPP project'], 'description': 'Patient and their relative receive three supportive, structured conversation with a trained nurse.\n\nPatient and their relative receive 4 days Retreat Weekend with supportive talk and activities', 'armGroupLabels': ['Rehabilitation program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Helle P Hansen, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Odense University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Helle Ploug Hansen', 'investigatorAffiliation': 'University of Southern Denmark'}}}}