Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-02-28 @ 7:28 AM
Study NCT ID:
NCT02716168
Status:
COMPLETED
Last Update Posted:
2020-10-20
First Post:
2016-03-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Partnership-Project - Reinforcing Partnership Between Cancer Patient, General Practitioner and Oncologist During Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058005', 'term': 'General Practitioners'}, {'id': 'D000072103', 'term': 'Oncologists'}], 'ancestors': [{'id': 'D010820', 'term': 'Physicians'}, {'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 281}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-16', 'studyFirstSubmitDate': '2016-03-03', 'studyFirstSubmitQcDate': '2016-03-22', 'lastUpdatePostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shared Care questionnaire', 'timeFrame': '7 month after inclusion', 'description': 'Patient reported outcome measure. Cancer patients assessment of their cancer trajectory and their assessment of the cooperation between their General Practitioner and the oncologist specialist.'}], 'secondaryOutcomes': [{'measure': 'Illness Intrusiveness Rating Scale (IIRS)', 'timeFrame': '4 and 7 month after inclusion', 'description': 'Patient reported outcome measure. Patients assessment of the cancer disease influence on their daily living.'}, {'measure': 'European Organisation for Research and Treatment of Cancer - Quality of Life questionnaire - Core 30 (EORTC QLQ C30)', 'timeFrame': '4 and 7 month after inclusion', 'description': 'Patient reported outcome measure. Cancer patients assessment of their quality of life'}, {'measure': 'European Organisation for Research and Treatment of Cancer - Quality of Life- information questionnaire (EORTC QLQ INFO25)', 'timeFrame': '4 and 7 month after inclusion'}, {'measure': 'Generalised Anxiety Disorder Assessment (GAD-7)', 'timeFrame': '4 and 7 month after inclusion', 'description': 'Patient reported outcome measure. Screening tool and severity measure for generalised anxiety disorder'}, {'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': '4 and 7 month after inclusion', 'description': 'Patient reported outcome measure.The questionnaire monitor the severity of depression and response to treatment.'}, {'measure': 'Oncologist assessment of a video consultation between the patient, General practitioner and oncologist.', 'timeFrame': 'Directly after the video consultation intervention', 'description': 'It measures the oncologist perception of the benefits with the video consultation intervention. Only the intervention group'}, {'measure': 'General practitioners assessment of a video consultation between the patient, General practitioner and oncologist.', 'timeFrame': 'Directly after the video consultation intervention', 'description': 'It measures the General Practitioners perception of the benefits with the video consultation intervention. Only the intervention group.'}, {'measure': 'Patients assessment of a video consultation between the patient, General practitioner and oncologist.', 'timeFrame': 'Directly after the video consultation intervention', 'description': 'It measures the patients perception of the benefits with the video consultation intervention.Only the intervention group'}, {'measure': 'General Practitioner cancer trajectory assessment', 'timeFrame': '4 month after the inclusion of the patient.', 'description': 'The General Practitioners assessment of the cooperation between the primary and secondary care regarding af specific cancer patient.'}]}, 'conditionsModule': {'keywords': ['Cancer', 'tele-health', 'Shared care', 'Continuity'], 'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '33952540', 'type': 'DERIVED', 'citation': "Hansen DG, Trabjerg TB, Sisler JJ, Sondergaard J, Jensen LH. Cross-sectoral communication by bringing together patient with cancer, general practitioner and oncologist in a video-based consultation: a qualitative study of oncologists' and nurse specialists' perspectives. BMJ Open. 2021 May 5;11(5):e043038. doi: 10.1136/bmjopen-2020-043038."}, {'pmid': '32318872', 'type': 'DERIVED', 'citation': 'Trabjerg TB, Jensen LH, Sondergaard J, Sisler JJ, Hansen DG. Cross-sectoral video consultations in cancer care: perspectives of cancer patients, oncologists and general practitioners. Support Care Cancer. 2021 Jan;29(1):107-116. doi: 10.1007/s00520-020-05467-0. Epub 2020 Apr 21.'}, {'pmid': '31238886', 'type': 'DERIVED', 'citation': 'Trabjerg TB, Jensen LH, Sondergaard J, Sisler JJ, Hansen DG. Improving continuity by bringing the cancer patient, general practitioner and oncologist together in a shared video-based consultation - protocol for a randomised controlled trial. BMC Fam Pract. 2019 Jun 25;20(1):86. doi: 10.1186/s12875-019-0978-8.'}]}, 'descriptionModule': {'briefSummary': "Background International guidelines underline the importance of strengthening the coordination and continuity of cancer care. The different roles of general practitioners and oncologists with regard to treatment, follow-up and rehabilitation during and after cancer treatment are often obscure to cancer patients. Parallel courses of healthcare are often taking place instead of coordinated care characterized by continuity and partnership between care providers. Patients may feel uncertain about the health professionals' skills and area of responsibility. Healthcare seeking and support during and after cancer treatment may, therefore, be inappropriate, leaving patients feeling insecure and lost between care providers.The study aims to design and evaluate a new way of communication and shared decision-making that brings the patient, the oncologist and general practitioner together in a shared video-consultation in the early phase of chemotherapeutic treatment. The effect of the intervention in addition to usual care will be tested in a randomized controlled trial at Vejle Hospital in the Region of Southern Denmark. Based on sample size calculation, investigators intent to include 300 patients at the Department of Oncology and their general practitioners. Results and process outcomes will be evaluated qualitatively and quantitatively, questionnaires to patients, general practitioners and oncologists, and data from registers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly referred cancer patient scheduled for chemotherapy at the Department for Oncology, Vejle Hospital, Region of Southern Denmark\n* Aged 18 years and over\n* Able to speak and read Danish\n* Mentally able to cooperate\n* Listed with a general practitioner (98 % of the danish population)\n* Written and verbal informed consent given\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT02716168', 'acronym': 'PSP', 'briefTitle': 'Partnership-Project - Reinforcing Partnership Between Cancer Patient, General Practitioner and Oncologist During Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'Partnership-Project - Reinforcing Partnership Between Cancer Patient, General Practitioner and Oncologist During Chemotherapy - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Partnership-Project'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Video consultation', 'description': 'Video consultation between cancer patient, general practitioner and oncologist at the start of chemotherapy treatment', 'interventionNames': ['Other: Shared video consultation between patient, general practitioner and oncologist']}, {'type': 'NO_INTERVENTION', 'label': 'usual care', 'description': 'Usual care. The patients General Practitioner will receive standard discharge summary and ambulant notes from the oncologist specialist'}], 'interventions': [{'name': 'Shared video consultation between patient, general practitioner and oncologist', 'type': 'OTHER', 'description': 'At the start of the patients chemotherapy treatment a shared video consultation between the patient, general practitioner and oncologist will bee arranged. The video consultation should address distribution of roles, comorbidity, medicine, depression and anxiety symptoms, relatives and social resources.', 'armGroupLabels': ['Video consultation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7100', 'city': 'Vejle', 'country': 'Denmark', 'facility': 'Department of Oncology, Vejle Hospital, Region of Southern Denmark', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Research Center of Cancer Rehabilitation', 'class': 'UNKNOWN'}, {'name': 'Research Unit of General Practice, Odense', 'class': 'OTHER'}, {'name': 'Vejle Hospital', 'class': 'OTHER'}, {'name': 'Region of Southern Denmark', 'class': 'OTHER'}, {'name': 'Odense Patient Data Explorative Network', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD fellow', 'investigatorFullName': 'Theis Trabjerg', 'investigatorAffiliation': 'University of Southern Denmark'}}}}