[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100466092":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":36,"centralContacts":66,"locations":74,"responsibleParty":183,"collaborators":185,"id":206,"slug":207,"hasResults":208,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":214,"sex":215,"minAge":216,"maxAge":24,"enrollmentInfo":217,"targetDuration":24,"studyType":220,"phases":221,"briefSummary":223,"conditions":224,"keywords":236,"overallStatus":91,"whyStopped":24,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":251},{"fullName":5,"class":6},"Pack Health","INDUSTRY",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group","EXPERIMENTAL","In addition to standard of care services at the participant's respective health system, and study specific collection of clinical, PRO, and wearable data, as well as microbiome specimens, individuals randomized to the intervention group will receive immediate enrollment to a 6-month digital health coaching program followed by 6 months monitoring via PRO, wearable, and clinical data collection. They will collect fecal microbiome samples at baseline (study enrollment) and month 6 following enrollment.",[13,14],"Behavioral: Digital Health Coaching Program","Device: Fitbit",{"label":16,"type":17,"description":18,"interventionNames":19},"Wait List Control Group","OTHER","In addition to standard of care services, individuals in the wait list control will be monitored via the collection of PRO, clinical, and wearable data for the first 6 months, along with fecal microbiome collection at study enrollment baseline (study enrollment) and month 6. At month 6 these individuals will be enrolled into the 6-month digital health coaching program, during which clinical, PRO and wearable data will continue to be collected. At the completion of the 6-month coaching these individuals will come off study and will not receive additional follow-up.",[13,14],{"label":21,"type":22,"description":23,"interventionNames":24},"Household Healthy Participants","NO_INTERVENTION","A cohort of consisting of adults without a cancer diagnosis residing in the same residence as participants, will be consented to collect fecal microbiome specimens to serve as a control for potential regional variation in microbiome dysbiosis. Up to 25 healthy controls will be enrolled per 100 participants at each study site. At sites enrolling fewer than 100 participants, an n up to 25% of the total patient enrollment sample will be approached for enrollment.",null,[26,31],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":24},"BEHAVIORAL","Digital Health Coaching Program","Coaching consisting of weekly calls and delivery of evidence-based content across health and wellness domains (e.g. nutrition, exercise, physical, emotional and financial health) up to 4 times weekly via text, email or mobile application.",[9,16],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":24},"DEVICE","Fitbit","Device: Fitbit A wrist-worn activity tracker allowing for the capture of physical activity, including but not limited to step-count and minutes of activity, to be captured daily.",[9,16],[37,41,43,46,48,51,54,57,60,63],{"name":38,"affiliation":39,"role":40},"Marilyn Hammer, PhD","Dana-Farber Cancer Institute","PRINCIPAL_INVESTIGATOR",{"name":42,"affiliation":39,"role":40},"Alexi Wright, MD",{"name":44,"affiliation":45,"role":40},"Elizabeth Arthur, PhD","Ohio State University",{"name":47,"affiliation":45,"role":40},"Jessica Krok-Schoen, PhD",{"name":49,"affiliation":50,"role":40},"Robin Lally, PhD","The University of Nebraska",{"name":52,"affiliation":53,"role":40},"Rachael Schmidt, DNP","Nebraska Medicine",{"name":55,"affiliation":56,"role":40},"Debra E Lyon, PhD","University of Florida College of Nursing",{"name":58,"affiliation":59,"role":40},"Anneliese Gonzalez, MD","UTHealth Houston McGovern Medical School",{"name":61,"affiliation":62,"role":40},"Kathrin Milbury, PhD","M.D. Anderson Cancer Center",{"name":64,"affiliation":65,"role":40},"Kristen Fessele, PhD","Memorial Sloan Kettering Cancer Center",[67,72],{"name":68,"role":69,"phone":70,"phoneExt":24,"email":71},"Kelly J Brassil, PhD","CONTACT","205-721-7542","dgxpharesearch@questdiagnostics.com",{"name":73,"role":69,"phone":70,"phoneExt":24,"email":71},"Jennifer Loftis, DNP",[75,89,110,120,135,145,168],{"facility":76,"status":77,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":24},"The University of Florida","ACTIVE_NOT_RECRUITING","Gainesville","Florida","32610","United States","US",{"type":84,"coordinates":85},"Point",[86,87],-82.32483,29.65163,{"lat":87,"lon":86},{"facility":90,"status":91,"city":92,"state":93,"zip":94,"country":81,"countryCode":82,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Dana Farber Cancer Institute","RECRUITING","Boston","Massachusetts","02215",{"type":84,"coordinates":96},[97,98],-71.05977,42.35843,{"lat":98,"lon":97},[101,104,108,109],{"name":38,"role":69,"phone":102,"phoneExt":24,"email":103},"347-271-0293","marilynj_hammer@dfci.harvard.edu",{"name":105,"role":69,"phone":106,"phoneExt":24,"email":107},"Alexi Wright, MD, MPH","617-632-2334","Alexi_Wright@dfci.harvard.edu",{"name":38,"role":69,"phone":24,"phoneExt":24,"email":24},{"name":105,"role":69,"phone":24,"phoneExt":24,"email":24},{"facility":111,"status":77,"city":112,"state":113,"zip":114,"country":81,"countryCode":82,"cosmosGeoPoint":115,"geoPoint":119,"contacts":24},"University of Nebraska Medical Center","Omaha","Nebraska","68106",{"type":84,"coordinates":116},[117,118],-95.94043,41.25626,{"lat":118,"lon":117},{"facility":65,"status":121,"city":122,"state":122,"zip":123,"country":81,"countryCode":82,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"NOT_YET_RECRUITING","New York","10065",{"type":84,"coordinates":125},[126,127],-74.00597,40.71427,{"lat":127,"lon":126},[130,134],{"name":131,"role":69,"phone":132,"phoneExt":24,"email":133},"Kristen L Fessele, PhD","646-449-1076","nuronr@mskcc.org",{"name":131,"role":69,"phone":24,"phoneExt":24,"email":24},{"facility":136,"status":77,"city":137,"state":138,"zip":139,"country":81,"countryCode":82,"cosmosGeoPoint":140,"geoPoint":144,"contacts":24},"The Ohio State University Wexner Medical Center","Columbus","Ohio","43210",{"type":84,"coordinates":141},[142,143],-82.99879,39.96118,{"lat":143,"lon":142},{"facility":146,"status":121,"city":147,"state":148,"zip":149,"country":81,"countryCode":82,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"The University of Texas MD Anderson Cancer Center","Houston","Texas","77030",{"type":84,"coordinates":151},[152,153],-95.36327,29.76328,{"lat":153,"lon":152},[156,159,163,164,166],{"name":61,"role":69,"phone":157,"phoneExt":24,"email":158},"713-745-2868","kmilbury@mdanderson.org",{"name":160,"role":69,"phone":161,"phoneExt":24,"email":162},"Meagan Whisenant, PhD","713-500-2279","meagan.whisenant@uth.tmc.edu",{"name":160,"role":69,"phone":24,"phoneExt":24,"email":24},{"name":165,"role":69,"phone":24,"phoneExt":24,"email":24},"Debu Tripathy, MD",{"name":167,"role":69,"phone":24,"phoneExt":24,"email":24},"Abbey Kaler, MSN",{"facility":169,"status":91,"city":147,"state":148,"zip":149,"country":81,"countryCode":82,"cosmosGeoPoint":170,"geoPoint":172,"contacts":173},"UT Health Houston",{"type":84,"coordinates":171},[152,153],{"lat":153,"lon":152},[174,178,182],{"name":175,"role":69,"phone":176,"phoneExt":24,"email":177},"Kaukab I Jafry, MD, MBBS","832 325 6537","Kaukab.I.Jafry@uth.tmc.edu",{"name":179,"role":69,"phone":180,"phoneExt":24,"email":181},"Martha Thompson","832-325-7706","Martha.Thompson@uth.tmc.edu",{"name":58,"role":69,"phone":24,"phoneExt":24,"email":24},{"type":184,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[186,188,190,192,194,196,197,199,200,201,203],{"name":187,"class":6},"Daiichi Sankyo",{"name":189,"class":6},"GlaxoSmithKline",{"name":191,"class":17},"University of Nebraska",{"name":193,"class":17},"Ohio State University Comprehensive Cancer Center",{"name":195,"class":17},"The University of Texas Health Science Center, Houston",{"name":62,"class":17},{"name":198,"class":17},"University of Florida",{"name":65,"class":17},{"name":39,"class":17},{"name":202,"class":6},"Gilead Sciences",{"name":204,"class":205},"National Institute of Nursing Research (NINR)","NIH","100466092","comprehensive-outcomes-for-after-cancer-health-100466092",false,"NCT05349227","Comprehensive Outcomes for After Cancer Health","Comprehensive Outcomes for After Cancer Health (COACH): the Feasibility and Impact of an MHealth Augmented Coaching Program for Self-Management in Cancer Survivors","COACH","Inclusion Criteria:\n\n1. Have primary diagnosis of cancer;\n2. Are within 1 year of completion of primary therapy OR have a diagnosis of metastatic cancer\n\n   1. For the purpose of this study, primary therapy is defined as treatment of curative intent, first-line or later, from which the individual is advancing to active surveillance or follow-up with or without maintenance therapy\n   2. For individuals with metastatic cancer, individuals may be included provided they completed primary therapy for a de novo diagnosis of metastatic disease within the last year, are within one year of completion of initial therapy for their primary cancer diagnosis for which disease progression has occurred, or who are within one year of receiving treatment for metastatic disease (including individuals currently receiving treatment).\n3. Are aged 18 years and older;\n4. Can read and consent to participate in the trial;\n5. Can read and speak English;\n6. Can complete study follow-up at pre-specified intervals;\n7. Have access to mobile technology (e.g. a smart phone or tablet) that would allow engagement in digital health coaching for the collection of PROs and wearable data.\n\nExclusion Criteria:\n\n1. Have a cognitive impairment (as assessed by their provider) that would prohibit the individual from engaging with the digital health coaching program or complete study assessments;\n2. Have a neurologic, musculoskeletal, or other comorbid condition that would impede their ability to engage in physical activity (as assessed by their provider)\n3. Have a life expectancy of \\<6 months, and\u002For\n4. Are on active treatment for relapsed disease. a. Individuals with disease progression or relapse which occurs following their consent to participate will be given the option to continue on study if they wish to do so. Data from individuals experiencing disease progression or relapse will be grouped for sub-analysis to explore if and how relapse impacts study outcomes.\n\nHealthy Volunteers must:\n\n1. Be adults aged 18 years or older or the age of majority in their state of residence, whichever is older.\n2. Must reside in the same dwelling as the patient participant\n3. Can read and consent to participate in the trial;\n4. Can read and speak English;\n5. Can complete study follow-up at pre-specified intervals;",true,"ALL","18 Years",{"count":218,"type":219},625,"ESTIMATED","INTERVENTIONAL",[222],"NA","This study intends to explore feasibility, acceptability, and outcomes related to the use of a digital health coaching intervention for individuals who have completed primary therapy for cancer. Up to 625 individuals with diverse cancer diagnoses will be enrolled across up to 8 clinical sites to participate in a randomized wait-list control study. Those in the intervention group will receive 6 months of digital coaching up front followed by 6 months of ongoing monitoring via patient reported and clinical outcomes, as well as wearable data. Those in the control group will be monitored via patient reported and clinical outcomes as well as wearable data for the first 6 months followed by 6 months of digital health coaching. Both groups will collect fecal microbiome samples at enrollment and month 6. The study aims to explore if and how digital health coaching may be used to enhance outcomes for individuals following completion of primary cancer therapy.",[225,226,227,228,229,230,231,232,233,234,235],"Ovarian Cancer","Breast Cancer","Lung Cancer","Gastric Cancer","Survivorship","Endometrial Cancer","Head and Neck Cancers","Prostate Cancers","Geriatric Oncology","Metastatic Breast Cancer","Metastatic Cancer",[237,238,239,240,241],"Patient Reported Outcome Measures","Physical Activity","Digital Coaching","Microbiome","Wearables","2024-12-06",{"date":244,"type":245},"2024-12-11","ACTUAL",{"date":247,"type":245},"2022-06-23",{"date":249,"type":219},"2027-05",{"name":5,"class":6},7]