Nctid:
NCT06231576
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000073496", "term"=>"Frailty"}], "ancestors"=>[{"id"=>"D000010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M1175", "name"=>"Frailty", "asFound"=>"Frailty", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "documentSection"=>{"largeDocumentModule"=>{"largeDocs"=>[{"date"=>"2024-01-16", "size"=>1382060, "label"=>"Study Protocol", "hasIcf"=>false, "hasSap"=>false, "filename"=>"Prot_000.pdf", "typeAbbrev"=>"Prot", "uploadDate"=>"2024-01-26T04:14", "hasProtocol"=>true}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"SUPPORTIVE_CARE", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>140}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-02-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2030-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-26", "studyFirstSubmitDate"=>"2023-11-17", "studyFirstSubmitQcDate"=>"2024-01-26", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"DNA methylation", "timeFrame"=>"At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery", "description"=>"Blood samples for DNA methylation profiling will be implemented in a machine learning algorithm to search for biomarkers reliably reflecting frailty and effect of prehabilitation."}, {"measure"=>"RNA methylation", "timeFrame"=>"At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery", "description"=>"Blood samples for RNA methylation profiling will be implemented in a machine learning algorithm to search for biomarkers reliably reflecting frailty and effect of prehabilitation."}, {"measure"=>"Metabolome", "timeFrame"=>"At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery", "description"=>"Blood samples for metabolome profiling will be implemented in a machine learning algorithm to search for biomarkers reliably reflecting frailty and effect of prehabilitation."}], "primaryOutcomes"=>[{"measure"=>"6MWT", "timeFrame"=>"At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery", "description"=>"Distance (in meters) walked in 6 minutes"}], "secondaryOutcomes"=>[{"measure"=>"EuroQol Group Questionnaire 5D (EQ-5D)", "timeFrame"=>"At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery", "description"=>"EQ-5D is a standardized measure of health-related quality of life with 5 dimensions, each dimension represented by a value 1-5 where higher value represents worse outcome."}, {"measure"=>"European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire", "timeFrame"=>"At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery", "description"=>"The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions. The questionnaire range from 0 to 100; a higher score represents a higher (\"better\") level of functioning, or a higher (\"worse\") level of symptoms."}, {"measure"=>"Generic Short Patient Experiences Questionnaire (GS-PEQ)", "timeFrame"=>"At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery", "description"=>"GS-PEQ is a questionnaire for collecting data about user experiences across different types of services. The questionnaire has 12 questions ranging from 1-5; a higher score represents a higher (\"better\") experience."}, {"measure"=>"Mortality", "timeFrame"=>"3 months after surgery", "description"=>"90-day mortality"}, {"measure"=>"Complications", "timeFrame"=>"3 months after surgery", "description"=>"Comprehensive Complication Index (CCI) reflects the gravity of the overall complication burden on the patient on a scale from 0 (no complication) to 100 (death)"}, {"measure"=>"Need of additional health care support", "timeFrame"=>"4-6 weeks after surgery", "description"=>"Use of health care support from the municipality, nursing homes etc"}, {"measure"=>"Aggregated length-of-stay (aLoS)", "timeFrame"=>"4-6 weeks after surgery", "description"=>"Total time in hospital (from surgery and any readmittance) within 30-days from surgery"}, {"measure"=>"Cost-effectiveness", "timeFrame"=>"3 months after surgery", "description"=>"An estimation of the resources used on the prehabilitation program will be compared to resources saved by shorter aLoS, less use of nursing home facilities and less need of community healthcare services"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Prehabilitation", "Colorectal cancer", "Frailty"], "conditions"=>["Cancer Colorectal", "Frailty", "Surgery"]}, "descriptionModule"=>{"briefSummary"=>"This clinical trial compares two different prehabilitation programs, with no organized prehabilitation, prior to major colorectal cancer surgery. The prehabilitation programs include intensive and coached physical exercise and optimized nutritional intake coupled with smoking cessation, physiological support and correction of poly-pharmacy.", "detailedDescription"=>"Patients are randomized to either a digital home-based program, a physical hospital-based program or no-organized prehabilitation. The eligible patients are anyone scheduled for colorectal cancer surgery who are fluent in Norwegian able to consent and to understand questionnaires. The main question the study aims to answer is whether a digital home-based program is non-inferior to a hospital-based program in terms of improved physical capacity and maintenance of life-quality. In addition, blood samples will be drawn at three time points, at inclusion, after intervention (prior to surgery) and 6 weeks after surgery to analyze and search for biomarkers reflecting patients' individual surgical risk profile and response to prehabilitation. Participants randomized to intervention, will be given psychological coaching and support, individualized nutritionist counselling, coached, structured and repeated 60 minutes daily exercises for three weeks prior to surgery. The control group will receive no organized prehabilitation in the period of time between diagnose and surgery."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Planned for major gastrointestinal cancer surgery\n* Fluent in Norwegian and able to consent and to understand questionnaires\n\nExclusion Criteria:\n\n* Inability to walk for six minutes or to rise independently from a chair\n* Inability to comprehend exercise program or to comply with written and oral instructions\n* Presence of a cardio-pulmonary condition that precludes exercise\n* Living in very remote areas making a hospital-based intervention group impossible to implement\n* Being without a permanent address\n* Admittance to a hospital facility for \\> 50% of the time from diagnosis to surgery"}, "identificationModule"=>{"nctId"=>"NCT06231576", "acronym"=>"dHOPE", "briefTitle"=>"Digital Home-Based Prehabilitation Before Surgery", "organization"=>{"class"=>"OTHER", "fullName"=>"Vestre Viken Hospital Trust"}, "officialTitle"=>"Digital Home-Based Prehabilitation Before Surgery", "orgStudyIdInfo"=>{"id"=>"23/08551"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Hospital", "description"=>"Prehabilitation at the hospital, with guidance by a dedicated physiotherapist physically present.", "interventionNames"=>["Other: Prehabilitation"]}, {"type"=>"EXPERIMENTAL", "label"=>"Digital", "description"=>"Prehabilitation at home, with guidance from a dedicated physiotherapist through a digital platform, realtime.", "interventionNames"=>["Other: Prehabilitation"]}, {"type"=>"NO_INTERVENTION", "label"=>"Control", "description"=>"Information about the general benefit of a healthy lifestyle at inclusion, thereafter no further follow-up prior to surgery."}], "interventions"=>[{"name"=>"Prehabilitation", "type"=>"OTHER", "description"=>"* Nutritional optimization: A nutritionist will perform a structured interview, comprehensive nutrition assessment, and provide personalized dietary advice. The main goal is to ensure optimal protein intake to support exercise-induced anabolism. A daily protein intake of 1.2-2.0 g/kg will meet needs as outlined in surgical nutrition guidelines.\n* Exercise: Based on current guidelines and instructed by a dedicated physiotherapist, for 1 hour per day preoperatively to increase muscle strength, aerobic capacity and physical endurance. Intensity will be based on the rate of perceived exertion using the Borg scale, a 15-graded scale ranging from very light to very hard. Resistance exercises will target upper/lower body, and abdominal muscles.\n* Psychological coaching and support: Performed as one interview during inclusion, followed by weekly phone calls by a study nurse coordinator during the preoperative intervention.", "armGroupLabels"=>["Digital", "Hospital"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Guro Kleve, MD", "role"=>"CONTACT", "email"=>"guro.kleve@vestreviken.no", "phone"=>"+47 32 80 30 00"}, {"name"=>"Rune Ougland, MD PhD", "role"=>"CONTACT", "email"=>"rune.ougland@vestreviken.no", "phone"=>"+47 32 80 30 00"}], "overallOfficials"=>[{"name"=>"Rune Ougland, MD PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Vestre Viken, Bærum Hospital, Norway"}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL", "SAP"], "timeFrame"=>"By end of 2024", "ipdSharing"=>"YES", "description"=>"Protocol and SAP will be published together with results from the pilot study", "accessCriteria"=>"Upon request"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Vestre Viken Hospital Trust", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Diakonhjemmet Hospital", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
