[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656732":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":32,"overallOfficials":36,"centralContacts":41,"locations":46,"responsibleParty":62,"collaborators":13,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":13,"eligibilityCriteria":69,"healthyVolunteers":66,"sex":70,"minAge":71,"maxAge":13,"enrollmentInfo":72,"targetDuration":13,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":13,"overallStatus":85,"whyStopped":13,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"safety and adverse events (AEs)","Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0","Through study completion; an average of 1 year.",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NON_RANDOMIZED","SINGLE_GROUP","SUPPORTIVE_CARE",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","2.1 Primary Objectives • To determine whether implementing routine ePRO symptom monitoring during NAT in patients with PDAC improves patient health-related quality of life (HRQoL) and experience with care compared with the pre-implementation period.\n\no To capture participant HRQoL and experience, the primary outcomes will be measured using the PROMIS-16 and CAHPS Cancer Care Survey , respectively.",[22,28],{"label":23,"type":24,"description":25,"interventionNames":26},"Post-Implementation Cohort","EXPERIMENTAL","Standard Clinical Care + QW ePRO",[27],"Other: Standard of Care",{"label":29,"type":24,"description":30,"interventionNames":31},"Pre-Implementation Cohort","Standard Clinical Care",[27],[33],{"type":6,"name":34,"description":34,"armGroupLabels":35,"otherNames":13},"Standard of Care",[23,29],[37],{"name":38,"affiliation":39,"role":40},"Rebecca A Snyder, MD","UT MD Anderson Cancer Center","PRINCIPAL_INVESTIGATOR",[42],{"name":38,"role":43,"phone":44,"phoneExt":13,"email":45},"CONTACT","713-792-0036","RSnyder@mdanderson.org",[47],{"facility":39,"status":13,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Houston","Texas","77044","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-95.36327,29.76328,{"lat":57,"lon":56},[60,61],{"name":38,"role":43,"phone":44,"phoneExt":13,"email":45},{"name":38,"role":40,"phone":13,"phoneExt":13,"email":13},{"type":63,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100656732","impact-of-routine-electronic-patient-reported-outcome-eprosymptom-monitoring-during-neoadjuvant-therapy-in-patients-withpancreatic-adenocarcinoma-on-patient-experience-and-clinicaloutcomes-a-prospective-pre-post-implementation-study-100656732",false,"NCT07829471","Impact of Routine Electronic Patient-Reported Outcome (ePRO)Symptom Monitoring During Neoadjuvant Therapy in Patients withPancreatic Adenocarcinoma on Patient Experience and ClinicalOutcomes: A Prospective Pre-Post Implementation Study","Eligibility Criteria\n\n* Age ≥18 years\n* Participants must have histologically confirmed PDAC that is respectable, borderline respectable, or locally advanced with potential for curative intent resection as defined by MD Anderson Cancer Center (Appendix V)\n* Participants must be eligible to receive systemic neoadjuvant therapy (chemotherapy +\u002F- radiation therapy) with intent for curative resection\n* Participants who will receive neoadjuvant therapy at an MD Anderson facility including Texas Medical Center and Houston area locations\n* Participants must be able to understand English or Spanish\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria\n\n* Definitively unresectable or metastatic disease at enrollment\n* Participants who received pre-referral chemotherapy, chemoradiotherapy, or previously attempted resection\n* Participants who had prior curative intent surgery for pancreatic cancer before entering the study\n* Participant with cognitive deficits that would preclude understanding of consent form and\u002For questionnaires\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Participants who do not understand English or Spanish\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia\n* Participants with uncontrolled underlying medical conditions\n* Participants receiving chemotherapy outside of the MD Anderson system","ALL","18 Years",{"count":73,"type":74},200,"ESTIMATED","INTERVENTIONAL",[77],"NA","To learn if routine symptom monitoring using questionnaires during chemotherapy and\u002For radiation therapy in patients with PDAC improves patient health-related quality of life and experience with care.",[80,81,82,83,84],"ePRO","Symptom Monitoring","Neoadjuvant Therapy","Pancreatic Adenocarcinoma","Clinical Outcomes","NOT_YET_RECRUITING","2026-09-17",{"date":88,"type":89},"2026-09-21","ACTUAL",{"date":91,"type":74},"2027-02-21",{"date":93,"type":74},"2032-07-01",{"name":5,"class":6},1]