[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582999":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":27,"centralContacts":35,"locations":41,"responsibleParty":90,"collaborators":92,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":98,"sex":104,"minAge":105,"maxAge":10,"enrollmentInfo":106,"targetDuration":10,"studyType":109,"phases":10,"briefSummary":110,"conditions":111,"keywords":115,"overallStatus":44,"whyStopped":10,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Abramson Cancer Center at Penn Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PGA Implementation Cohort (n=150)",null,"All eligible patients will be evaluated on their completion rates of the practical geriatric assessment.",[13],"Other: Practical Geriatric Assessment",{"label":15,"type":10,"description":10,"interventionNames":16},"Correlative analyses cohort (n=100)",[13,17],"Other: Correlation of body composition PGA and step count with outcomes",[19,23],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"Practical Geriatric Assessment","The PGA will be administered via the electronic health record (EHR), available for patients to complete independently prior to an initial medical oncology visit, or during the visit with staff assistance. Results from the PGA will be shared automatically with clinical teams via the EHR, including a Best Practice Alert highlighting any identified geriatric impairment(s) and ASCO's recommendation for PGA-adapted care.",[15,9],{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"Correlation of body composition PGA and step count with outcomes","Monitoring of step counts (measured via FitBit) and body composition (measured via standard abdominal CT scans)",[15],[28,32],{"name":29,"affiliation":30,"role":31},"Ramy Sedhom, M.D.","Penn Princeton","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":34,"role":31},"Samuel Takvorian, M.D.","Abramson Cancer Center",[36],{"name":37,"role":38,"phone":39,"phoneExt":10,"email":40},"Abigail Gottschalk, MPH","CONTACT","2156156825","abigail.blaush@pennmedicine.upenn.edu",[42,60,76],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Penn Medicine Princeton Medical Center","RECRUITING","Princeton","New Jersey","08540","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-74.65905,40.34872,{"lat":54,"lon":53},[57],{"name":29,"role":38,"phone":58,"phoneExt":10,"email":59},"9178164858","ramy.sedhom@pennmedicine.upenn.edu",{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":48,"countryCode":49,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Lancaster General Hospital","NOT_YET_RECRUITING","Lancaster","Pennsylvania","17602",{"type":51,"coordinates":67},[68,69],-76.30551,40.03788,{"lat":69,"lon":68},[72],{"name":73,"role":38,"phone":74,"phoneExt":10,"email":75},"Efrat Dotan, M.D.","7175449401","efrat.dotan@pennmedicine.upenn.edu",{"facility":77,"status":44,"city":78,"state":64,"zip":79,"country":48,"countryCode":49,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Pennsylvania Hospital","Philadelphia","19107",{"type":51,"coordinates":81},[82,83],-75.16362,39.95238,{"lat":83,"lon":82},[86],{"name":87,"role":38,"phone":88,"phoneExt":10,"email":89},"Samuel Takvorian, M.D., M.S.","2156626319","samuel.takvorian@pennmedicine.upenn.edu",{"type":91,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[93],{"name":94,"class":95},"Bristol-Myers Squibb","INDUSTRY","100582999","practical-geriatric-assessment-pga-implementation-strategies-and-correlative-evaluations-pace-70-100582999",false,"NCT06870617","Practical Geriatric Assessment (PGA) Implementation Strategies and Correlative Evaluations (PACE-70)","Practical Geriatric Assessment (PGA) Implementation Strategies and Correlative Evaluations for Older Adults With Cancer (PACE-70): A Hybrid Implementation-effectiveness Study","PACE-70","For PGA Implementation Cohort, patients must meet the following criteria:\n\n1. Age greater than or equal to 70 years.\n2. Diagnosis of advanced or metastatic solid malignancy\n3. Initiating a new line of palliative-intent systemic therapy with a prevalence of grade 3 toxicity exceeding 50%.\n\nFor Correlative Analysis Cohort, patients must additionally meet the following criteria:\n\n1. Must read and speak English and be able to fill out surveys\n2. Ability to walk independently or with the use of an assistive device (e.g., walker, cane)\n3. Consents to participate in correlative analysis cohort with Fitbit monitoring, body composition analysis, and self-report surveys\n4. Have a smartphone able to operate with the Fitbit\n\nFor PGA Implementation Cohort, there are no specific exclusion criteria other than not meeting inclusion criteria.\n\nFor Correlative Analysis Cohort, patients will be excluded if meeting any of the following criteria:\n\n1. Unable to effectively read and speak English\n2. Reliance on a wheelchair, ECOG of 3 or above, clinically bedbound, or unable to walk without assistance every day for the past 7 days (ECOG 3 is confined to bed or chair for more than 50% of waking hours)\n3. Concurrent enrollment in a therapeutic clinical trial (as clinical trials often have a substantial symptom-reporting structure). Non-therapeutic clinical trial enrollment is permitted\n4. Lack of clinician consent to approach patient","ALL","70 Years",{"count":107,"type":108},150,"ESTIMATED","OBSERVATIONAL","The use of a geriatric assessment to inform oncologic care for older persons with cancer is an evidence-based practice that improves patient-clinician communication, reduces treatment-related toxicity, and is recommended by national guidelines. However, the implementation of a geriatric assessment can be time-consuming and burdensome, leading to suboptimal use in clinical practice. Developed and endorsed by the American Society for Clinical Oncology (ASCO), the Practical Geriatric Assessment (PGA) is designed to improve clinical usability and adoption, but its implementation in real-world settings has not been evaluated. The PACE-70 study aims to evaluate PGA implementation and resultant chemotherapy dose modification among older adults with advanced cancer treated in a community setting. An exploratory aim will evaluate how the PGA, body composition (via abdominal computed tomography scan) and step count monitoring (via FitBit) correlate with chemotherapy toxicity and other clinical outcomes.",[112,113,114],"Geriatric Assessment","Advanced Cancer","Toxicity",[102,116,117,118,119],"Practical geriatric assessment","body composition in cancer","step count in cancer","Start low go slow","2025-10-02",{"date":122,"type":123},"2025-10-03","ACTUAL",{"date":125,"type":123},"2025-07-01",{"date":127,"type":108},"2026-10-01",{"name":5,"class":6},3]