Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-02-18 @ 11:41 AM
Study NCT ID:
NCT04411251
Status:
COMPLETED
Last Update Posted:
2023-06-02
First Post:
2020-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Oncology Day Care Unit Programme With Two Different Focuses
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-01', 'studyFirstSubmitDate': '2020-05-25', 'studyFirstSubmitQcDate': '2020-05-28', 'lastUpdatePostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Qualitative interviews', 'timeFrame': '12 weeks and 24 weeks after inclusion', 'description': 'Qualitative assessment will be carried out in qualitative interviews in 20 patients participating in the study. The interviews will be recorded, transcribed and analyzed with qualitative content analysis.'}], 'primaryOutcomes': [{'measure': 'Functional Assessment of Cancer Therapy - General (FACT-G)', 'timeFrame': 'Change from date of inclusion (baseline) at 12 weeks and at 24 weeks', 'description': 'Assessing full scale, range 0-108, higher score meaning a better outcome'}], 'secondaryOutcomes': [{'measure': 'Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)', 'timeFrame': 'Date of inclusion (baseline), after 12 weeks, after 24 weeks', 'description': 'Assessing full scale, range 0-40, higher score meaning a better outcome'}, {'measure': 'Functional Assessment of Cancer Therapy: Fatigue (FACT-F)', 'timeFrame': 'Date of inclusion (baseline), after 12 weeks, after 24 weeks', 'description': 'Assessing full scale, range 0-52, higher score meaning a better outcome'}, {'measure': 'WHO-Five Well-Being Index (WHO-5)', 'timeFrame': 'Date of inclusion (baseline), after 12 weeks, after 24 weeks', 'description': 'Assessing full scale, range 0-25, higher score meaning a better outcome'}, {'measure': 'Perceived Benefits of Nature Questionnaire (PBNQ)', 'timeFrame': 'Date of inclusion (baseline), after 12 weeks, after 24 weeks', 'description': 'mean score of the 11 items, range 1-7, lower score meaning a better outcome'}, {'measure': 'Perceived Stress Scale (PSS-10)', 'timeFrame': 'Date of inclusion (baseline), after 12 weeks, after 24 weeks', 'description': 'Assessing full scale, range 0-40, lower score meaning a better outcome'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'Date of inclusion (baseline), after 12 weeks, after 24 weeks', 'description': 'Assessing full scale, range 0-42, lower score meaning a better outcome'}, {'measure': 'Flourishing Scale (FS-D)', 'timeFrame': 'Date of inclusion (baseline), after 12 weeks, after 24 weeks', 'description': 'Assessing full scale, range 8-56, higher score meaning a better outcome'}, {'measure': 'Freiburg Mindfulness Inventory (FMI)', 'timeFrame': 'Date of inclusion (baseline), after 12 weeks, after 24 weeks', 'description': 'Assessing full scale, range 0-56, higher score meaning a better outcome'}, {'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': 'Date of inclusion (baseline), after 12 weeks, after 24 weeks', 'description': 'Assessing full scale, range 0-28, lower score meaning a better outcome'}, {'measure': 'Self-Efficacy Scale - Short Form (ASKU)', 'timeFrame': 'Date of inclusion (baseline), after 12 weeks, after 24 weeks', 'description': 'mean score of the 3 items, range 1-5'}, {'measure': 'Self-Compassion Scale (SCS-D)', 'timeFrame': 'Date of inclusion (baseline), after 12 weeks, after 24 weeks', 'description': 'mean score of 12 items, range 1-5, higher score meaning a better outcome'}, {'measure': 'Behavioral questions: alcohol consumption', 'timeFrame': 'Date of inclusion (baseline), after 12 weeks, after 24 weeks', 'description': 'Number of alcoholic beverages on average per week in the last month'}, {'measure': 'Behavioral questions: relaxation', 'timeFrame': 'Date of inclusion (baseline), after 12 weeks, after 24 weeks', 'description': 'Relaxation behavior on average per week in the last month in minutes'}, {'measure': 'Behavioral questions: cigarettes', 'timeFrame': 'Date of inclusion (baseline), after 12 weeks, after 24 weeks', 'description': 'Number of cigarettes on average per week in the last month in minutes'}, {'measure': 'Sociodemographic Measurements', 'timeFrame': 'Date of inclusion (baseline)', 'description': 'Age, gender, education level, household income, employment status, marital status, complete family history, current and previous diseases and co-morbidities, current medication intake'}, {'measure': 'Body weight', 'timeFrame': 'Date of inclusion (baseline), after 12 weeks, after 24 weeks', 'description': 'kg'}, {'measure': 'Expectation questions', 'timeFrame': 'Date of inclusion (baseline)', 'description': 'For intervention 1 and intervention 2 on a 5-point likert scale from 1 (nothing at all) to 5 (very strong)'}, {'measure': 'Behavioral questions: sport', 'timeFrame': 'Date of inclusion (baseline), after 12 weeks, after 24 weeks', 'description': 'Sports behavior on average per week in the last month in minutes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nature', 'Mind-Body Therapies', 'Mindfulness', 'Yoga', 'Meditation'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effects of a nature-centred integrative oncology day care unit programme ("outdoor concept") compared with an already established integrative oncology day care unit programme ("indoor concept").'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- cancer diagnosis\n\nExclusion Criteria:\n\n* cognitive impairment that would interfere with questionnaire replies or the intervention\n* pregnancy or lactation\n* known serious mental illness\n* participation in another study'}, 'identificationModule': {'nctId': 'NCT04411251', 'acronym': 'TK-Onko', 'briefTitle': 'Evaluation of a Oncology Day Care Unit Programme With Two Different Focuses', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Integrative Oncology - Evaluation of a Oncology Day Care Unit Programme With Two Different Focuses', 'orgStudyIdInfo': {'id': 'TK-Onko'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Outdoor', 'description': 'Nature-centered therapy in a near-natural area', 'interventionNames': ['Behavioral: Nature-near integrative day care unit programme']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Indoor', 'description': 'Conventional therapy in rooms mainly in a hospital building', 'interventionNames': ['Behavioral: Conventional integrative day care unit programme']}], 'interventions': [{'name': 'Nature-near integrative day care unit programme', 'type': 'BEHAVIORAL', 'description': 'Interventions based on the Mind Body Medicine in Integrative and Complementary Medicine (MICOM) programme', 'armGroupLabels': ['Outdoor']}, {'name': 'Conventional integrative day care unit programme', 'type': 'BEHAVIORAL', 'description': 'Interventions based on the Mind Body Medicine in Integrative and Complementary Medicine (MICOM) programme', 'armGroupLabels': ['Indoor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14109', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Andreas Michalsen', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}