{
  "FullStudy":{
    "Rank":217553,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01519895",
          "OrgStudyIdInfo":{
            "OrgStudyId":"HKCTR-1336"
          },
          "Organization":{
            "OrgFullName":"Hospital Authority, Hong Kong",
            "OrgClass":"OTHER_GOV"
          },
          "BriefTitle":"Effectiveness of Telephone Intervention for Colorectal Cancer Caregivers",
          "OfficialTitle":"Effectiveness of Telephone-based Intervention on Distress, Burden and Quality of Life of Chinese Caregivers of Colorectal Cancer Patients"
        },
        "StatusModule":{
          "StatusVerifiedDate":"April 2015",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"June 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"August 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 11, 2012",
          "StudyFirstSubmitQCDate":"January 24, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 27, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"April 14, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"April 15, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Shum Nga Fan",
            "ResponsiblePartyInvestigatorTitle":"Department of Surgery, Colorectal Specialist Nurse, Principal Investigator",
            "ResponsiblePartyInvestigatorAffiliation":"Hospital Authority, Hong Kong"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Hospital Authority, Hong Kong",
            "LeadSponsorClass":"OTHER_GOV"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "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"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Psychological Stress"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "quality of life",
              "anxiety",
              "stress",
              "carers",
              "colorectal or colon cancer"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 2"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Supportive Care",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"140",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Existing care",
                "ArmGroupType":"No Intervention",
                "ArmGroupDescription":"routine existing care"
              },{
                "ArmGroupLabel":"Telephone intervention",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"in addition to provide telephone intervention support",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Telephone intervention"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Behavioral",
                "InterventionName":"Telephone intervention",
                "InterventionDescription":"counseling and education support",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Telephone intervention"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Distress level",
                "PrimaryOutcomeDescription":"Effect of telephone intervention on distress level measured at pre-discharged(baseline) and 2 weeks and 4 weeks and 8 weeks post intervention .",
                "PrimaryOutcomeTimeFrame":"Change of distress level at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Burden of care",
                "SecondaryOutcomeDescription":"Effect of telephone intervention on burden of care measured at pre-discharged(baseline) and 2 weeks and 4 weeks and 8 weeks post intervention",
                "SecondaryOutcomeTimeFrame":"Measured at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention"
              },{
                "SecondaryOutcomeMeasure":"Quality of life",
                "SecondaryOutcomeDescription":"Effect of telephone intervention at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention",
                "SecondaryOutcomeTimeFrame":"Measured at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nFamily members with newly diagnosed colorectal cancer within the past 4 week and treated in Queen Mary Hospital\nSelf identified as formal or informal family caregivers\nOver 18 years old\nChinese\nCantonese speaking\n\nExclusion Criteria:\n\nCognitive disability\nDomestic helpers or maids\nNon Chinese",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"90 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"N F Shum",
                "OverallOfficialAffiliation":"Queen Mary Hospital, Hong Kong",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Queen Mary Hospital",
                "LocationCity":"Hong Kong",
                "LocationZip":"852",
                "LocationCountry":"China"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000013315",
                "ConditionMeshTerm":"Stress, Psychological"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000001526",
                "ConditionAncestorTerm":"Behavioral Symptoms"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M2905",
                "ConditionBrowseLeafName":"Anxiety Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M14688",
                "ConditionBrowseLeafName":"Stress, Psychological",
                "ConditionBrowseLeafAsFound":"Psychological Stress",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M3399",
                "ConditionBrowseLeafName":"Behavioral Symptoms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T6054",
                "ConditionBrowseLeafName":"Quality of Life",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BXM",
                "ConditionBrowseBranchName":"Behaviors and Mental Disorders"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}