Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-02-18 @ 3:46 AM
Study NCT ID:
NCT02333968
Status:
UNKNOWN
Last Update Posted:
2015-01-08
First Post:
2014-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self-management Support in Cancer Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000072716', 'term': 'Cancer Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 174}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-07', 'studyFirstSubmitDate': '2014-12-29', 'studyFirstSubmitQcDate': '2015-01-07', 'lastUpdatePostDateStruct': {'date': '2015-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain intensity (Brief Pain Inventory - Short Form (BPI-SF)', 'timeFrame': '12 weeks', 'description': 'As measured with the Brief Pain Inventory - Short Form (BPI-SF)'}, {'measure': 'Change in cancer related quality of life (European Organisation for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ-C30 version 3)', 'timeFrame': '12 weeks', 'description': 'As measured with the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ-C30 version 3)'}], 'secondaryOutcomes': [{'measure': 'Change in self-efficacy (Chronic Pain Self-efficacy Scale (CPSS)', 'timeFrame': '12 weeks', 'description': 'As measured with the Chronic Pain Self-efficacy Scale (CPSS)'}, {'measure': 'Change in knowledge about cancer pain (Pain Knowledge Questionnaire (PKQ)', 'timeFrame': '12 weeks', 'description': 'As measured with the Pain Knowledge Questionnaire (PKQ)'}, {'measure': 'Change in anxiety and depression (Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': '12 weeks', 'description': 'As measured with the Hospital Anxiety and Depression Scale (HADS)'}, {'measure': "Change in pain medication use (Brief Pain Inventory - Short Form (BPI-SF), a cost diary and a pharmacist's overview)", 'timeFrame': '12 weeks', 'description': "As measured with the Brief Pain Inventory - Short Form (BPI-SF), a cost diary and a pharmacist's overview"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cancer pain', 'Self-management', 'Randomized controlled trial'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '25986294', 'type': 'DERIVED', 'citation': 'Hochstenbach LM, Courtens AM, Zwakhalen SM, van Kleef M, de Witte LP. Self-management support intervention to control cancer pain in the outpatient setting: a randomized controlled trial study protocol. BMC Cancer. 2015 May 19;15:416. doi: 10.1186/s12885-015-1428-1.'}]}, 'descriptionModule': {'briefSummary': 'Pain is a prevalent and distressing symptom in patients with cancer, having an enormous impact on functioning and quality of life. Integration of patient self-management and professional care by means of care technology provides new opportunities in the outpatient setting. In this project a technology based and nurse delivered multicomponent self-management support intervention has been developed. Important components include monitoring, feedback, education, and nurse support. Following feasibility evaluation, the primary aim of this randomized controlled trial is to assess the effect of the intervention regarding pain intensity and quality of life as compared to care as usual. Secondary outcomes of the effect evaluation are self-efficacy, knowledge, anxiety and depression, and pain medication use. Besides, a cost-evaluation and summative process evaluation will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of cancer\n* Patients who are under (palliative) anti-tumour treatment in a day clinic or outpatient clinic, or patients who have no treatment options available anymore\n* Cancer (treatment related) pain \\> 2 weeks\n* Pain is defined as a patient reported pain score of 4 or more on a numerical rating scale (scale 0-10)\n* Living at home\n\nExclusion Criteria:\n\n* Expected life expectancy \\< 3 months\n* Chronic non-cancer pain\n* Known cognitive impairments\n* Participation in other studies that interfere with this study\n* Not being able to read and understand the Dutch language\n* Reduced vision\n* Non-reachable by phone'}, 'identificationModule': {'nctId': 'NCT02333968', 'briefTitle': 'Self-management Support in Cancer Pain', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Effects of a Multifaceted Teleguided Pain Care Program in Patients With Cancer Pain', 'orgStudyIdInfo': {'id': 'UM 2011-5079'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Self-management support', 'interventionNames': ['Behavioral: Self-management support']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Care as usual'}], 'interventions': [{'name': 'Self-management support', 'type': 'BEHAVIORAL', 'description': "The 12-week intervention consists of an iPad application for patients that is connected to a web application for nurses. Every morning and evening patients register pain and related symptoms by use of a pain diary. Patients are also requested to register medication intake. Graphical feedback is provided based on registered pain scores and medication intakes. Patients receive education on causes and treatment of pain, symptoms that require action, and methods to better control pain. Patients communicate with nurses via text message functionality within the application. Specialized nurses remotely monitor and analyze the patients' situation once every workday. Nurses have the opportunity to collaborate with the treating physician, pain specialist or multidisciplinary team.", 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Heerlen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Asiong Jie, MD, PhD', 'role': 'CONTACT', 'email': 'G.Jie@atriummc.nl', 'phone': '+31 455766666'}], 'facility': 'Atrium Medical Center', 'geoPoint': {'lat': 50.88365, 'lon': 5.98154}}, {'city': 'Maastricht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Annemie Courtens, PhD', 'role': 'CONTACT', 'email': 'a.courtens@mumc.nl', 'phone': '+31 433877548'}], 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'centralContacts': [{'name': 'Laura Hochstenbach, MSc', 'role': 'CONTACT', 'email': 'l.hochstenbach@maastrichtuniversity.nl', 'phone': '+31 433881691'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Atrium Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}