{
  "FullStudy":{
    "Rank":217576,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01519596",
          "OrgStudyIdInfo":{
            "OrgStudyId":"IRB00019467"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"NCI-2012-00003",
                "SecondaryIdType":"Registry Identifier",
                "SecondaryIdDomain":"CTRP (Clinical Trial Reporting Program)"
              },{
                "SecondaryId":"CCCWFU 97711",
                "SecondaryIdType":"Other Identifier",
                "SecondaryIdDomain":"Wake Forest University Health Sciences"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"Wake Forest University Health Sciences",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Symptom-Adapted Physical Activity Intervention in Minimizing Physical Function Decline in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy",
          "OfficialTitle":"Minimizing Physical Function Decline in Older Adults Receiving Chemotherapy"
        },
        "StatusModule":{
          "StatusVerifiedDate":"August 2019",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"October 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"March 5, 2015",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"February 5, 2017",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 20, 2012",
          "StudyFirstSubmitQCDate":"January 24, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 27, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"August 14, 2019",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"August 16, 2019",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Wake Forest University Health Sciences",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"National Cancer Institute (NCI)",
                "CollaboratorClass":"NIH"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No",
          "IsFDARegulatedDrug":"No",
          "IsFDARegulatedDevice":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"This is a randomized clinical trial that studies symptom-adapted physical activity intervention in minimizing physical function decline in older patients with acute myeloid leukemia (AML) undergoing chemotherapy. Physical activity may help decrease functional impairment and improve the quality of life in patients with AML undergoing chemotherapy.",
          "DetailedDescription":"PRIMARY OBJECTIVES:\n\nI. To evaluate the feasibility of conducting a symptom-adapted, randomized behavioral intervention designed to improve physical function in older adults receiving chemotherapy for AML.\n\nII. To estimate the effect size of the physical activity intervention on change in an objective measure of physical function, SPPB (short physical performance battery).\n\nSECONDARY OBJECTIVES:\n\nI. To estimate the effects of the physical activity intervention on self-reported physical function, health-related quality of life, and symptoms (depression, distress, fatigue).\n\nOUTLINE: Patients are randomized to 1 of 2 treatment arms.\n\nARM I: Patients participate in an orientation session introducing the exercise program and protocol, reviewing fundamental principles, and demonstrating each activity. Patients also receive educational materials to facilitate orientation and adherence. Patients are offered 20-50 minute standard, intermediate, and/or low intensity physical activity sessions 5 days a week for 4 weeks. Patients also receive lifestyle-related counseling for 20-30 minutes once weekly.\n\nARM II: Patients undergo usual care for 4 weeks.\n\nAfter completion of study treatment, patients are followed up every two weeks for two months and then monthly until week 24."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Adult Acute Myeloid Leukemia in Remission",
              "Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities",
              "Adult Acute Myeloid Leukemia With Del(5q)",
              "Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)",
              "Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)",
              "Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)",
              "Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)",
              "Recurrent Adult Acute Myeloid Leukemia",
              "Untreated Adult Acute Myeloid Leukemia"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Supportive Care",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"70",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Arm I (physical activity)",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Patients participate in an orientation session introducing the exercise program and protocol, reviewing fundamental principles, and demonstrating each activity. Patients also receive educational materials to facilitate orientation and adherence. Patients are offered 20-50 minute standard, intermediate, and/or low intensity physical activity sessions 5 days a week for 4 weeks. Patients also receive lifestyle-related counseling for 20-30 minutes once weekly.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: quality-of-life assessment",
                    "Other: counseling intervention",
                    "Behavioral: exercise intervention",
                    "Other: educational intervention"
                  ]
                }
              },{
                "ArmGroupLabel":"Arm II (usual care)",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Patients undergo usual care for 4 weeks.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: quality-of-life assessment",
                    "Procedure: standard follow-up care"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Procedure",
                "InterventionName":"quality-of-life assessment",
                "InterventionDescription":"Ancillary studies",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Arm I (physical activity)",
                    "Arm II (usual care)"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "quality of life assessment"
                  ]
                }
              },{
                "InterventionType":"Other",
                "InterventionName":"counseling intervention",
                "InterventionDescription":"Receive lifestyle-related counseling",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Arm I (physical activity)"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "counseling and communications studies"
                  ]
                }
              },{
                "InterventionType":"Behavioral",
                "InterventionName":"exercise intervention",
                "InterventionDescription":"Undergo physical activity intervention",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Arm I (physical activity)"
                  ]
                }
              },{
                "InterventionType":"Other",
                "InterventionName":"educational intervention",
                "InterventionDescription":"Receive educational materials",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Arm I (physical activity)"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "intervention, educational"
                  ]
                }
              },{
                "InterventionType":"Procedure",
                "InterventionName":"standard follow-up care",
                "InterventionDescription":"Undergo usual care",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Arm II (usual care)"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Feasibility, in terms of participation rates and barriers to recruitment and retention",
                "PrimaryOutcomeDescription":"Number of exercise sessions completed, dropout rates, completion rates of the physical function measures, and completion rates of questionnaires will be recorded. Adherence will be defined as completion of at least 60% of the offered sessions.",
                "PrimaryOutcomeTimeFrame":"Approximately 4 weeks"
              },{
                "PrimaryOutcomeMeasure":"Magnitude and trajectory of changes in objective physical function",
                "PrimaryOutcomeDescription":"Characterized using mixed model analysis of variance (ANOVA) with an appropriate error structure to account for the correlated nature of the data.",
                "PrimaryOutcomeTimeFrame":"Approximately 4 weeks"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Self-reported physical function using the SPPB, PAT-D, MAT-sf, grip strength, and lower extremity strength",
                "SecondaryOutcomeTimeFrame":"Approximately 4 weeks"
              },{
                "SecondaryOutcomeMeasure":"Self-reported quality of life",
                "SecondaryOutcomeTimeFrame":"Approximately 24 weeks"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nDiagnosis of AML with pathologic confirmation by World Health Organization (WHO) criteria\nPlanned induction chemotherapy\nAbsence of active medical problems that preclude participation in exercise (including, but not limited to: bleeding, acute thrombosis, ischemia, hemodynamic instability, uncontrolled pain)\nPatient must be ambulatory or able to walk with a cane\nPatients must have limited cognitive deficits (< 3 incorrect responses on the Pfeiffer Mental Status Scale)\nAdequate English skills to understand and complete questionnaires\nAbility to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\nPresence of active medical conditions precluding participation to exercise (e.g., ischemia, bleeding, thrombosis, uncontrolled pain, hemodynamic instability)\nInability to ambulate",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"60 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Heidi Klepin",
                "OverallOfficialAffiliation":"Wake Forest University Health Sciences",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Wake Forest University Health Sciences",
                "LocationCity":"Winston-Salem",
                "LocationState":"North Carolina",
                "LocationZip":"27157",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000007938",
                "ConditionMeshTerm":"Leukemia"
              },{
                "ConditionMeshId":"D000007951",
                "ConditionMeshTerm":"Leukemia, Myeloid"
              },{
                "ConditionMeshId":"D000015470",
                "ConditionMeshTerm":"Leukemia, Myeloid, Acute"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000009370",
                "ConditionAncestorTerm":"Neoplasms by Histologic Type"
              },{
                "ConditionAncestorId":"D000009369",
                "ConditionAncestorTerm":"Neoplasms"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M12",
                "ConditionBrowseLeafName":"Congenital Abnormalities",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9528",
                "ConditionBrowseLeafName":"Leukemia",
                "ConditionBrowseLeafAsFound":"Leukemia",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M9538",
                "ConditionBrowseLeafName":"Leukemia, Myeloid",
                "ConditionBrowseLeafAsFound":"Myeloid Leukemia",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M16710",
                "ConditionBrowseLeafName":"Leukemia, Myeloid, Acute",
                "ConditionBrowseLeafAsFound":"Acute Myeloid Leukemia",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M10898",
                "ConditionBrowseLeafName":"Neoplasms by Histologic Type",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T4021",
                "ConditionBrowseLeafName":"Myeloid Leukemia",
                "ConditionBrowseLeafAsFound":"Myeloid Leukemia",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"T181",
                "ConditionBrowseLeafName":"Acute Myeloid Leukemia",
                "ConditionBrowseLeafAsFound":"Acute Myeloid Leukemia",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"T187",
                "ConditionBrowseLeafName":"Acute Non Lymphoblastic Leukemia",
                "ConditionBrowseLeafAsFound":"Acute Myeloid Leukemia",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC16",
                "ConditionBrowseBranchName":"Diseases and Abnormalities at or Before Birth"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC04",
                "ConditionBrowseBranchName":"Cancers and Other Neoplasms"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}