Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-28 @ 4:35 PM
Study NCT ID:
NCT02028832
Status:
COMPLETED
Last Update Posted:
2017-05-08
First Post:
2013-12-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Integrative Medicine Trial Pilot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 872}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-03', 'studyFirstSubmitDate': '2013-12-16', 'studyFirstSubmitQcDate': '2014-01-06', 'lastUpdatePostDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Resource Utilization/Cost', 'timeFrame': 'Analysis of this outcome to be limited to patients admitted for at least 2 days and for not more than 30 days', 'description': 'Resource utilization and related costs will be compared between study arms'}], 'primaryOutcomes': [{'measure': 'Enrollment', 'timeFrame': 'up to 5 days', 'description': 'Enrollment of study participants over length of study which will inform conduct of a larger study in this population'}], 'secondaryOutcomes': [{'measure': 'Change in pain', 'timeFrame': 'up to 5 days', 'description': 'For pre-verbal children: Faces, Legs, Activity, Cry, Consolability tool Verbal children: faces Pain Scale-Revised'}, {'measure': 'Change in nausea/vomiting', 'timeFrame': 'up to 5 days', 'description': 'Baxter Retching Faces scale'}, {'measure': 'Change in anxiety', 'timeFrame': 'up to 5 days', 'description': 'Pediatrics Anxiety Faces scale'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'up to 5 days', 'description': "BC Children's Hospital Patient Safety Questionnaire; Canadian Pediatric Trigger tool"}, {'measure': 'Parent satisfaction with patient care', 'timeFrame': 'up to 5 days', 'description': "Hospital's standardized satisfaction survey; State-Trait Anxiety Invenvtory"}, {'measure': 'Length of hospital stay', 'timeFrame': 'up to 5 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pain', 'nausea/vomiting', 'anxiety', 'complementary and alternative medicine', 'pediatric', 'oncology', 'cost-effectiveness'], 'conditions': ['Pain', 'Nausea', 'Vomiting', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'This study will investigate if adding complementary therapies such as acupuncture, massage and reiki to inpatient pediatric care is feasible and what the effects are on outcomes such as patient symptoms, cost, safety, satisfaction and length of stay.', 'detailedDescription': 'Study Objective: To determine if a pediatric integrative medicine (PIM) service is effective in reducing overall symptoms of pain, nausea/vomiting, and/or anxiety (PNVA), length of stay, and costs, in hospitalized children when compared to conventional care. In this context, "integrative" refers to a combined approach of complementary and conventional medical therapies in an evidence-based fashion.\n\nDesign: cluster trial; 2-arm controlled evaluation study in pediatric oncology, general pediatrics and pediatric cardiology. Intervention will be offered during a 6-month PIM period following a 6 month control period.\n\nPopulation: Inclusion criteria: (i) In-patients in participating division and (ii) informed consent/assent. Exclusion criteria: (i) lack of parent participation, fluency in English, or informed consent\n\nIntervention: Recommendations for specific CAM therapies will be determined by a staff PIM pediatrician. Any combination of the following CAM therapies (dose, duration, amount to be based on patient need as assessed by CAM provider, patient, and parent): acupuncture/acupressure, massage, Reiki; all are to be offered in addition to usual care.\n\nControl: Usual care.\n\nOutcomes: Primary outcome: feasibility (i.e enrollment); Secondary outcomes: (i) PNVA symptom management, (ii) need for conventional pharmacotherapy, (iii) adverse events; (iv) parent and health care provider satisfaction with care provided, v) length of stay; and vi) cost-effectiveness (analysis of this outcome to be limited to patients admitted for at least 2 days and for not more than 30 days).\n\nSignificance: To our knowledge, this study will be the first comparative effectiveness trial to assess the impact of PIM for hospitalized children with cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* (i) all children, aged 0-16 years, who are admitted to Pediatric Oncology, General Pediatrics and Pediatric Cardiology at the Stollery Children's Hospital, Edmonton, Canada who\n* (ii) can communicate in English; and\n* (iii) give informed consent/assent\n\nExclusion Criteria:\n\n* (i) cannot communicate in English;\n* (ii) lack of parent availability to participate; or\n* iii) lack of informed consent."}, 'identificationModule': {'nctId': 'NCT02028832', 'acronym': 'PIM', 'briefTitle': 'Pediatric Integrative Medicine Trial Pilot', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Pilot Study of Pediatric Integrative Medicine in Pediatric Oncology, General Pediatrics and Pediatric Cardiology', 'orgStudyIdInfo': {'id': 'PIM1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': 'Usual care provided to pediatric inpatients', 'interventionNames': ['Procedure: Usual care']}, {'type': 'EXPERIMENTAL', 'label': 'PIM consult and service provision', 'description': 'Pediatric integrative medicine service (PIM) through which pediatric inpatients will have the option of supplementing their usual care with acupuncture/acupressure, massage, and/or reiki', 'interventionNames': ['Procedure: PIM consult and service provision', 'Procedure: Usual care']}], 'interventions': [{'name': 'PIM consult and service provision', 'type': 'PROCEDURE', 'description': 'If service is requested, treatment options include acupuncture/acupressure, massage, and reiki', 'armGroupLabels': ['PIM consult and service provision']}, {'name': 'Usual care', 'type': 'PROCEDURE', 'description': 'Usual care consists of all conventional care options in pediatric oncology including medication and other therapies.', 'armGroupLabels': ['PIM consult and service provision', 'Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': "Stollery Childrens' Hospital", 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Sunita Vohra, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lotte & John Hecht Memorial Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sunita Vohra', 'investigatorAffiliation': 'University of Alberta'}}}}