{ "FullStudy":{ "Rank":217919, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01515124", "OrgStudyIdInfo":{ "OrgStudyId":"U54CA155850", "OrgStudyIdType":"U.S. NIH Grant/Contract", "OrgStudyIdLink":"https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=U54CA155850&Fy=all" }, "Organization":{ "OrgFullName":"Milton S. Hershey Medical Center", "OrgClass":"OTHER" }, "BriefTitle":"The Women In Steady Exercise Research (WISER) Survivor Trial", "OfficialTitle":"The Women In Steady Exercise Research (WISER) Survivor Trial & Cost of Illness and Cost Effectiveness of Alternative Management Strategies", "Acronym":"WISER Survivor" }, "StatusModule":{ "StatusVerifiedDate":"June 2019", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 2016", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"May 2016", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 18, 2012", "StudyFirstSubmitQCDate":"January 18, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 23, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"June 21, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"June 24, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Kathryn Schmitz", "ResponsiblePartyInvestigatorTitle":"Professor, Public Health Sciences", "ResponsiblePartyInvestigatorAffiliation":"Milton S. Hershey Medical Center" }, "LeadSponsor":{ "LeadSponsorName":"Milton S. Hershey Medical Center", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"Yes", "IsFDARegulatedDrug":"No", "IsFDARegulatedDevice":"No" }, "DescriptionModule":{ "BriefSummary":"WISER Survivor is a one year weight loss and exercise study for sedentary breast cancer survivors who are overweight or obese with breast cancer related lymphedema. There will be four groups in this trial: exercise only, weight loss only, exercise and weight-loss combined, and a control group. The primary purpose of this study is to test the effects of these interventions on clinical lymphedema outcomes. Secondary outcomes include weight loss, breast cancer related biomarkers, and quality of life. To the extent that funding will be available, participants will be followed long term to examine effects on recurrence and mortality." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Lymphedema" ] }, "KeywordList":{ "Keyword":[ "Lymphedema", "Strength training intervention", "Weight loss intervention", "Breast cancer recurrence", "Cost Effectiveness" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Supportive Care", "DesignMaskingInfo":{ "DesignMasking":"Single", "DesignMaskingDescription":"All participants asked at the start of each measurement encounter not to inform measurement staff of their randomization group status. All measurement staff asked to guess group status at end of each measurement encounter. Patterns of responses beyond chance result in corrective action to improve masking (e.g.; requests from PI for participants to mask group status)", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"450", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Lymphedema Care Only", "ArmGroupType":"No Intervention", "ArmGroupDescription":"All 4 groups receive lymphedema care as follows:\n\n2 custom fitted compression garments (baseline and 6 months)\nevaluations for flare-ups at request (and at each measurement time point)\nlymphedema treatment by a certified lymphatic therapist upon detection of a flare-up, paid for by the study. No limit was placed on number of sessions." },{ "ArmGroupLabel":"Exercise only", "ArmGroupType":"Experimental", "ArmGroupDescription":"The Exercise Intervention combines 60-90 minute twice-weekly supervised weight-lifting sessions with 180 minutes of weekly aerobic exercise. Women will be trained by certified fitness professionals in both the weight-lifting intervention and in safely increasing their aerobic exercise activity over 6 weekly sessions, and then monitored through phone contact, and monthly in-person sessions. All exercise participants will be provided with 'Power Blocks' which are adjustable dumbbells with which they can increase resistance in 1-2 pound increments from 1-21 pounds. All weight training will be done in their homes except for the first 6 weekly session and monthly check-in sessions. Exercise only group members also received the Lymphedema care intervention described above.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Exercise Intervention" ] } },{ "ArmGroupLabel":"Weight loss only", "ArmGroupType":"Experimental", "ArmGroupDescription":"The Weight Loss Intervention begins with a 24 week intensive phase that includes weekly meetings and provision of all meals and snacks from a commercial manufacturer (NutriSystem®, Inc., Fort Washington, PA). Daily caloric intake will be strictly controlled during this first 24 weeks at 1200-1500 calories per day. Participants will be guided to stay at the same number of calories per day until reaching goal weight, followed by a gradual increase in caloric intake (of approximately 500 calories/d) to maintain their weight throughout the remainder of the intervention. The treatment groups will be led by registered dietitians and will receive ongoing supervision via telephone and email contact. Weight loss only group members also received the Lymphedema care intervention described above.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Weight Loss Intervention" ] } },{ "ArmGroupLabel":"Exercise and Weight loss combined", "ArmGroupType":"Experimental", "ArmGroupDescription":"Participants in this group will receive a combination of the supervised twice-weekly weight training sessions and the weight loss program. Combined group members also received the Lymphedema care intervention described above.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Exercise Intervention", "Behavioral: Weight Loss Intervention" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Behavioral", "InterventionName":"Exercise Intervention", "InterventionDescription":"The Exercise Intervention combines the twice-weekly weight-lifting intervention from PAL with the 180 minutes of weekly aerobic exercise from the recently completed WISER trial and the ongoing WISER Sister Trial. Women will be trained by certified fitness professionals in both the PAL weight-lifting intervention and in safely increasing their aerobic exercise activity over 6 weekly sessions, and then monitored through phone contact, and monthly in-person sessions.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Exercise and Weight loss combined", "Exercise only" ] } },{ "InterventionType":"Behavioral", "InterventionName":"Weight Loss Intervention", "InterventionDescription":"The Weight Loss Intervention begins with a 24 week intensive phase that includes weekly meetings and provision of all meals and snacks from a commercial manufacturer (NutriSystem, Inc., Fort Washington, PA). Daily caloric intake will be strictly controlled during this first 24 weeks at 1200-1500 calories per day.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Exercise and Weight loss combined", "Weight loss only" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Percent interlimb difference, change over 12 months.", "PrimaryOutcomeDescription":"Arm volumes for affected and unaffected limbs will be measured by perometry and the % difference will be determined at baseline and 12 months. the absolute percentage point difference of differences (% interlimb difference at 12 months minus % interlimb difference at baseline) will be the primary outcome", "PrimaryOutcomeTimeFrame":"Baseline and 12 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Clinical Lymphedema Events", "SecondaryOutcomeDescription":"Flare-ups and cellulitic infections (number and type recorded)", "SecondaryOutcomeTimeFrame":"Data collected over the 12 month follow-up, with events collected as reported" },{ "SecondaryOutcomeMeasure":"Clinical Evaluation Score for Lymphedema", "SecondaryOutcomeDescription":"Standardized clinical evaluation survey completed by certified lymphatic therapists", "SecondaryOutcomeTimeFrame":"Baseline and 12 months" },{ "SecondaryOutcomeMeasure":"Norman Lymphedema Survey", "SecondaryOutcomeDescription":"Thirteen symptoms, recorded within a standardized survey (Norman Lymphedema Survey)", "SecondaryOutcomeTimeFrame":"Baseline and 12 months" },{ "SecondaryOutcomeMeasure":"Weight loss", "SecondaryOutcomeDescription":"body weight loss over 12 months", "SecondaryOutcomeTimeFrame":"Baseline and 12 months" },{ "SecondaryOutcomeMeasure":"Biomarkers: Estradiol", "SecondaryOutcomeDescription":"circulating estradiol levels in the blood", "SecondaryOutcomeTimeFrame":"baseline and 12 months" },{ "SecondaryOutcomeMeasure":"Biomarkers: Testosterone", "SecondaryOutcomeDescription":"circulating testosterone levels in the blood", "SecondaryOutcomeTimeFrame":"baseline and 12 months" },{ "SecondaryOutcomeMeasure":"Biomarkers - Sex Hormone Binding Globulin", "SecondaryOutcomeDescription":"circulating sex hormone binding globulin levels in the blood", "SecondaryOutcomeTimeFrame":"baseline and 12 months" },{ "SecondaryOutcomeMeasure":"Inflammation: Interleukin six", "SecondaryOutcomeDescription":"Circulating interleukin six levels in the blood", "SecondaryOutcomeTimeFrame":"baseline and 12 months" },{ "SecondaryOutcomeMeasure":"Inflammation: C reactive protein", "SecondaryOutcomeDescription":"Circulating c reactive protein levels in the blood", "SecondaryOutcomeTimeFrame":"baseline and 12 months" },{ "SecondaryOutcomeMeasure":"Adiponectin", "SecondaryOutcomeDescription":"circulating Adiponectin levels in the blood", "SecondaryOutcomeTimeFrame":"baseline and 12 months" },{ "SecondaryOutcomeMeasure":"Leptin", "SecondaryOutcomeDescription":"circulating leptin levels in the blood", "SecondaryOutcomeTimeFrame":"baseline and 12 months" },{ "SecondaryOutcomeMeasure":"F2-isoprostanes", "SecondaryOutcomeDescription":"circulating F2-isoprostane levels in the blood", "SecondaryOutcomeTimeFrame":"baseline and 12 months" },{ "SecondaryOutcomeMeasure":"Insulin", "SecondaryOutcomeDescription":"circulating insulin levels in the blood", "SecondaryOutcomeTimeFrame":"baseline and 12 months" },{ "SecondaryOutcomeMeasure":"Glucose", "SecondaryOutcomeDescription":"circulating glucose levels in the blood", "SecondaryOutcomeTimeFrame":"baseline and 12 months" },{ "SecondaryOutcomeMeasure":"insulin like growth factor one", "SecondaryOutcomeDescription":"circulating levels of insulin like growth factor one in the blood", "SecondaryOutcomeTimeFrame":"baseline and 12 months" },{ "SecondaryOutcomeMeasure":"insulin like growth factor binding protein three", "SecondaryOutcomeDescription":"circulating levels of insulin like growth factor binding protein three in the blood", "SecondaryOutcomeTimeFrame":"baseline and 12 months" },{ "SecondaryOutcomeMeasure":"Upper limb lymphedema twenty seven", "SecondaryOutcomeDescription":"27 item survey on lymphedema quality of life", "SecondaryOutcomeTimeFrame":"baseline and 12 months" },{ "SecondaryOutcomeMeasure":"body image and relationship survey", "SecondaryOutcomeDescription":"32 item survey on body image specifically developed for breast cancer survivors", "SecondaryOutcomeTimeFrame":"baseline and 12 months" } ] }, "OtherOutcomeList":{ "OtherOutcome":[ { "OtherOutcomeMeasure":"breast cancer recurrence", "OtherOutcomeDescription":"participants will be followed for breast cancer recurrence", "OtherOutcomeTimeFrame":"10 years post trial" },{ "OtherOutcomeMeasure":"mortality", "OtherOutcomeDescription":"participants will be followed for mortality", "OtherOutcomeTimeFrame":"10 years post trial" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nbreast cancer survivor\noverweight or obese (BMI of 25 or greater)\nmust have breast cancer related lymphedema\nat least 6 months post-treatment (e.g. surgery, chemotherapy, or radiotherapy) but there will be no upper limit on time elapsed from diagnosis\nthe eligible age range will have no lower limit.\ncurrently free of cancer\n\nExclusion Criteria:\n\nmedical conditions or medications that would prohibit participation in an exercise program or would negatively impact our ability to test our primary aims\ninability to walk for 6 minutes unaided\nextremely obese (body mass index greater or equal to 50 kg/m2)\nplans for additional (e.g. curative or reconstructive) surgery during the study period\nself-report of weight-lifting within the past year\nalready engaging in 3 or more times weekly aerobic activity of moderate intensity\nplanning to move away from the area over the next year\ncurrent use of weight loss medication (OTC or prescription)\nself-report of alcohol or substance abuse within the past 12 months, including at-risk drinking (current consumption of more than 14 alcoholic drinks per week)\nweight loss of greater than 10 % in the past 3 months\nhistory of bariatric surgery\nwomen who are pregnant", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"Female", "MaximumAge":"80 Years", "StdAgeList":{ "StdAge":[ "Child", "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Kathryn H. Schmitz, MPH,PhD", "OverallOfficialAffiliation":"Penn State University", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"The Penn TREC Survivorship Center", "LocationCity":"Hershey", "LocationState":"Pennsylvania", "LocationZip":"17033", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"20052559", "ReferenceType":"background", "ReferenceCitation":"Speck RM, Courneya KS, Mâsse LC, Duval S, Schmitz KH. An update of controlled physical activity trials in cancer survivors: a systematic review and meta-analysis. J Cancer Surviv. 2010 Jun;4(2):87-100. doi: 10.1007/s11764-009-0110-5. Epub 2010 Jan 6. Review. Erratum in: J Cancer Surviv. 2011 Mar;5(1):112." },{ "ReferenceType":"background", "ReferenceCitation":"Hewitt M, Greenfield, S., Stovall, E. , ed. From Cancer Patient to Cancer Survivor: Lost in Transition. 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