Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2025-12-29 @ 10:56 PM
Study NCT ID:
NCT01519895
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2012-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Telephone Intervention for Colorectal Cancer Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-14', 'studyFirstSubmitDate': '2012-01-11', 'studyFirstSubmitQcDate': '2012-01-24', 'lastUpdatePostDateStruct': {'date': '2015-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distress level', 'timeFrame': 'Change of distress level at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention', 'description': 'Effect of telephone intervention on distress level measured at pre-discharged(baseline) and 2 weeks and 4 weeks and 8 weeks post intervention .'}], 'secondaryOutcomes': [{'measure': 'Burden of care', 'timeFrame': 'Measured at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention', 'description': 'Effect of telephone intervention on burden of care measured at pre-discharged(baseline) and 2 weeks and 4 weeks and 8 weeks post intervention'}, {'measure': 'Quality of life', 'timeFrame': 'Measured at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention', 'description': 'Effect of telephone intervention at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['quality of life', 'anxiety', 'stress', 'carers', 'colorectal or colon cancer'], 'conditions': ['Psychological Stress']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effectiveness of the telephone intervention program for caregivers of colorectal cancer.', 'detailedDescription': 'telephone Intervention refer to provide counseling and education to caregivers of colorectal cancer by mode of telephone'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Family members with newly diagnosed colorectal cancer within the past 4 week and treated in Queen Mary Hospital\n* Self identified as formal or informal family caregivers\n* Over 18 years old\n* Chinese\n* Cantonese speaking\n\nExclusion Criteria:\n\n* Cognitive disability\n* Domestic helpers or maids\n* Non Chinese'}, 'identificationModule': {'nctId': 'NCT01519895', 'briefTitle': 'Effectiveness of Telephone Intervention for Colorectal Cancer Caregivers', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hospital Authority, Hong Kong'}, 'officialTitle': 'Effectiveness of Telephone-based Intervention on Distress, Burden and Quality of Life of Chinese Caregivers of Colorectal Cancer Patients', 'orgStudyIdInfo': {'id': 'HKCTR-1336'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Existing care', 'description': 'routine existing care'}, {'type': 'EXPERIMENTAL', 'label': 'Telephone intervention', 'description': 'in addition to provide telephone intervention support', 'interventionNames': ['Behavioral: Telephone intervention']}], 'interventions': [{'name': 'Telephone intervention', 'type': 'BEHAVIORAL', 'description': 'counseling and education support', 'armGroupLabels': ['Telephone intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '852', 'city': 'Hong Kong', 'country': 'China', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'N F Shum', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Queen Mary Hospital, Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Authority, Hong Kong', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Surgery, Colorectal Specialist Nurse, Principal Investigator', 'investigatorFullName': 'Shum Nga Fan', 'investigatorAffiliation': 'Hospital Authority, Hong Kong'}}}}