{ "FullStudy":{ "Rank":217837, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516190", "OrgStudyIdInfo":{ "OrgStudyId":"11-182" }, "Organization":{ "OrgFullName":"Dana-Farber Cancer Institute", "OrgClass":"OTHER" }, "BriefTitle":"The Preoperative Health & Body Study", "OfficialTitle":"The Preoperative Health & Body Study", "Acronym":"PreHab" }, "StatusModule":{ "StatusVerifiedDate":"December 2019", "OverallStatus":"Active, not recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"August 2011", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"June 2015", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"September 2020", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 19, 2012", "StudyFirstSubmitQCDate":"January 23, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"December 11, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"December 12, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Jennifer A. Ligibel, MD", "ResponsiblePartyInvestigatorTitle":"Principal Investigator", "ResponsiblePartyInvestigatorAffiliation":"Dana-Farber Cancer Institute" }, "LeadSponsor":{ "LeadSponsorName":"Dana-Farber Cancer Institute", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Yale University", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Susan G. Komen Breast Cancer Foundation", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"This study is designed to look at the changes that occur in women who take part in exercise and Mind-Body programs between breast cancer diagnosis and breast surgery. The investigators will look at changes in stress, anxiety, mood and quality of life, to see if these types of short programs can make women feel better during this time. The investigators are also interested in looking at whether a short exercise or Mind-Body program leads to any changes in markers in breast cancer cells, such as their growth and death rates, or in blood hormones such as insulin, which have been linked to breast cancer development.\n\nSince the investigators do not know if these blood or tumor tests have any relationship to cancer recurrence, the investigators do not plan to share the results of these tests with you or your physician." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Breast Cancer" ] }, "KeywordList":{ "Keyword":[ "stage I-III breast cancer" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Supportive Care", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"49", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Exercise Group", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Supervised exercise sessions and independent exercise", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Exercise" ] } },{ "ArmGroupLabel":"Mind-Body Group", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Surgical preparation program", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Surgical preparation program" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Behavioral", "InterventionName":"Exercise", "InterventionDescription":"Supervised exercise sessions and independent exercise", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Exercise Group" ] } },{ "InterventionType":"Behavioral", "InterventionName":"Surgical preparation program", "InterventionDescription":"Book, tapes, CD", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Mind-Body Group" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Impact of Exercise on Ki-67", "PrimaryOutcomeDescription":"To explore the impact of exercise upon Ki-67, a tissue-based biomarker associated with breast cancer risk and progression.", "PrimaryOutcomeTimeFrame":"3 years" },{ "PrimaryOutcomeMeasure":"Feasibility of intervention in women with newly diagnosed breast cancer", "PrimaryOutcomeDescription":"To evaluate the feasibility of conducting a window of opportunity study utilizing exercise and mind-body intervention in women with newly diagnosed breast cancer", "PrimaryOutcomeTimeFrame":"3 years" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Impact of exercise on biomarkers", "SecondaryOutcomeDescription":"To evaluate the impact of a 3-6 week intensive exercise intervention upon concentrations of serum matabolic and inflammatory biomarkers (insulin, glucose, IGF-1, IGFBP's, IL-2, IL-6, CRP, TNFa)", "SecondaryOutcomeTimeFrame":"3 years" },{ "SecondaryOutcomeMeasure":"Impact of exercise on receptors", "SecondaryOutcomeDescription":"To explore the impact of a 3-6 week exercise intervention upon expression of metabolic, sex steroid and related receptors in malignant breast tissue.", "SecondaryOutcomeTimeFrame":"3 years" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nNewly diagnosed, histologically confirmed stage I-III breast cancer\nPlanning to undergo definitive surgical management with lumpectomy or mastectomy with in the next 8 weeks.\nWilling and able to participate in the intervention for at least 3 weeks prior to surgery.\nECOG performance status of 0 or 1\nApproval by oncologist or surgeon\nWillingness to be randomized.\nEnglish speaking and able to read English\n\nExclusion Criteria:\n\nConcurrent other malignancy or history of other malignancy treated within the past 3 years (other than non-melanoma skin cancer or in situ cervical cancer)\nPresence of metastatic disease\nScheduled to receive any form of neoadjuvant cancer therapy\nLocally advanced breast cancer not amenable to primary surgery\nHistory of prior ipsilateral breast cancer\nTaking tamoxifen, raloxifene or an aromatase inhibitor at the time of breast cancer diagnosis\nAbsolute contraindications to maximal exercise testing as recommended by the American Thoracic Society\nAny condition which in the investigator's opinion makes the subject unsuitable for study participation\nParticipating in another clinical study with competing study outcomes\nPregnant (i.e., positive beta-HCG) or breast feeding\nUnable to comply with protocol and/or not available for follow-up assessments\nParticipation in more than 90 minutes a week of moderate-intensity recreational activity (not including activities such as gardening, bowling, golfing with a cart) as assessed by the Leisure Score Index of Godin Leisure- Time Exercise Questionnaire (LSI) (Appendix I) or recent participation (past 6 months) in two or more strength training sessions per week.\nDiabetes mellitus requiring insulin or oral agents; patients with diet-controlled diabetes will be allowed to participate", "HealthyVolunteers":"No", "Gender":"Female", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Jennifer A Ligibel, MD", "OverallOfficialAffiliation":"Dana-Farber Cancer Institute", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Dana-Farber Cancer Institute", "LocationCity":"Boston", "LocationState":"Massachusetts", "LocationZip":"02215", "LocationCountry":"United States" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000001943", "ConditionMeshTerm":"Breast Neoplasms" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000009371", "ConditionAncestorTerm":"Neoplasms by Site" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" },{ "ConditionAncestorId":"D000001941", "ConditionAncestorTerm":"Breast Diseases" },{ "ConditionAncestorId":"D000012871", "ConditionAncestorTerm":"Skin Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M3802", "ConditionBrowseLeafName":"Breast Neoplasms", "ConditionBrowseLeafAsFound":"Breast Cancer", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M3800", "ConditionBrowseLeafName":"Breast Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14257", "ConditionBrowseLeafName":"Skin Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"BC17", "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }