{
  "FullStudy":{
    "Rank":217755,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01517256",
          "OrgStudyIdInfo":{
            "OrgStudyId":"DFM 09-595"
          },
          "Organization":{
            "OrgFullName":"McMaster University",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"A Pilot Study Evaluating a Multidisciplinary Chronic Pain Group Therapy in a Primary Care Setting",
          "OfficialTitle":"Living Everyday Above-and-beyond Pain Research (LEAP): A Pilot Study Evaluating a Multidisciplinary Chronic Pain Group Therapy in a Primary Care Setting",
          "Acronym":"LEAP"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"November 2009"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"November 2011",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"November 2011",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 16, 2012",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 20, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 25, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"McMaster University",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{},
        "DescriptionModule":{
          "BriefSummary":"The investigators will evaluate the effectiveness of \"Living Everyday Above-and-beyond Pain\" (LEAP) program in the primary care setting. LEAP is a multidisciplinary chronic pain group therapy developed for the two clinic sites of McMaster Family Health Team: McMaster Family Practice and Stonechurch Family Health Centre. LEAP aims to improve patients'quality of life, interaction with the health care system and their health care utilization. This is a pilot study to evaluate mainly feasibility. The investigators will make use of both experimental and qualitative methods gather evidence of the programs success, strengths and weaknesses."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Chronic Pain"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Chronic pain",
              "Primary care",
              "Multidisciplinary group therapy",
              "Embedded mixed-methods study"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Supportive Care",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"60",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Early Intervention Group",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Living Everyday Above-and-beyond Pain (LEAP)"
                  ]
                }
              },{
                "ArmGroupLabel":"Delayed Intervention Group",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupDescription":"Initially wait-listed and served as control group. But later participants underwent the experimental intervention.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Wait-listed"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Behavioral",
                "InterventionName":"Living Everyday Above-and-beyond Pain (LEAP)",
                "InterventionDescription":"8-week multidisciplinary group therapy aiming consisting of education about the nature of chronic pain, pacing and goal setting, mindfulness medication techniques, cognitive reflections on beliefs, impulses and obsessions, physical activation, and medication management.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Early Intervention Group"
                  ]
                }
              },{
                "InterventionType":"Other",
                "InterventionName":"Wait-listed",
                "InterventionDescription":"Patients are wait-listed while awaiting participation to the LEAP program.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Delayed Intervention Group"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Quality of Life",
                "PrimaryOutcomeDescription":"This will utilize the SF-36 QOL questionnaire.",
                "PrimaryOutcomeTimeFrame":"8 months"
              },{
                "PrimaryOutcomeMeasure":"Health care utilization",
                "PrimaryOutcomeDescription":"This will be based on a chart review to assess the number of consultations with their family physician and other clinicians (Nurse practitioners, registered nurse, dietitian, social worker).",
                "PrimaryOutcomeTimeFrame":"8 months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Qualitative process evaluation (Perceptions of participants regarding the intervention)",
                "SecondaryOutcomeDescription":"This outcome assesses the views of the participants regarding the strengths and weaknesses of the intervention. It will assess ways to improve the recruitment process and retention of participants in the group, satisfaction of the participants regarding the processes (group dynamics, time, format, contents, etc), perceptions of participants regarding the effectiveness of the program, and suggestion of participants regarding ways to improve the program.",
                "SecondaryOutcomeTimeFrame":"16 months"
              },{
                "SecondaryOutcomeMeasure":"Pain medication use",
                "SecondaryOutcomeDescription":"This will be based on a standardized questionnaire developed by the researchers and a chart review regarding request for early refill and increased dose of medications due to worsening of chronic pain.",
                "SecondaryOutcomeTimeFrame":"8 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\n18 years and older\ndiagnosed with chronic pain\n\nExclusion Criteria:\n\nchronic pain related to cancer, pelvic pain or headache\ninability to speak or write in English\npatient is unable to attend and participate in group treatment sessions on their own\nsubstance use or mental health problems of a severity making group treatment participation impossible\ncurrently participating in another cognitive-behavioral pain management program\npatient is receiving palliative care or has been diagnosed with an illness expecting to cause death within one year",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"McMaster Family Practice Clinic",
                "LocationCity":"Hamilton",
                "LocationState":"Ontario",
                "LocationZip":"L8S 1A4",
                "LocationCountry":"Canada"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"23875181",
                "ReferenceType":"derived",
                "ReferenceCitation":"Angeles RN, Guenter D, McCarthy L, Bauer M, Wolfson M, Chacon M, Bullock L. Group interprofessional chronic pain management in the primary care setting: a pilot study of feasibility and effectiveness in a family health team in Ontario. Pain Res Manag. 2013 Sep-Oct;18(5):237-42. Epub 2013 Jul 19."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000059350",
                "ConditionMeshTerm":"Chronic Pain"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000010146",
                "ConditionAncestorTerm":"Pain"
              },{
                "ConditionAncestorId":"D000009461",
                "ConditionAncestorTerm":"Neurologic Manifestations"
              },{
                "ConditionAncestorId":"D000012816",
                "ConditionAncestorTerm":"Signs and Symptoms"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M28029",
                "ConditionBrowseLeafName":"Chronic Pain",
                "ConditionBrowseLeafAsFound":"Chronic Pain",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M11649",
                "ConditionBrowseLeafName":"Pain",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10987",
                "ConditionBrowseLeafName":"Neurologic Manifestations",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC10",
                "ConditionBrowseBranchName":"Nervous System Diseases"
              }
            ]
          }
        }
      }
    }
  }
}