[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06765707":3,"trial-entities:NCT06765707":147,"trial-summary:NCT06765707":152},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":41,"secondary_outcomes":50,"sex":90,"minimum_age":91,"maximum_age":92,"healthy_volunteers":93,"eligibility_criteria":94,"std_ages":111,"locations":114,"central_contacts":139,"overall_officials":140,"references":141,"see_also_links":146},"NCT06765707","PRO00051010","Symptom Monitoring Using Patient-Report to Improve Medication Use","Symptom Monitoring Using Patient-Reported Outcomes to Optimize Medication Use","ENROLLING_BY_INVITATION","2029-08","2025-07","2025-07-24","2025-06-23","Medical College of Wisconsin","OTHER",true,"This is an intervention targeting patients at risk for non-adherence to endocrine therapy after primary treatments for hormone-positive breast cancer. In a randomized study, the study team will collect patient-reported symptoms monthly from participants through surveys. Pharmacists who specialize in cancer at the patients' hospital will give patients recommendations to help improve their symptoms and address other barriers so they can continue daily endocrine therapy medications.","This study will test whether oncology teams can adapt and combine models from intensive oncologic care and chronic noncancer care to support long-term oral oncologic medication adherence through better symptom monitoring and management. It will identify patients at risk of nonadherence through electronic health records and target them with a symptom monitoring and management intervention. The study will use patient-reported outcomes (PROs) to identify symptoms that may cause nonadherence and will involve clinical pharmacist-led follow-up.\n\nObjectives:\n\n1. Assess the impact of the intervention on adherence to oral endocrine therapy.\n2. Evaluate the durability of adherence one-year post-intervention.\n3. Describe the impact on symptoms and explore mechanisms for adherence improvement.\n\nIntervention:\n\nDuring the intervention phase, patients will receive symptom monitoring and pharmacist-led management based on patient-reported outcomes (PROs).\n\nSymptom Monitoring:\n\n1. Patients will report symptoms monthly for 12 months either online or via an interactive voice recording (IVR) system.\n2. Symptoms will be assessed using PROs focusing on issues like pain, hot flashes, anxiety, and more.\n3. Severe symptoms will trigger follow-up for management.\n\nSymptom Management:\n\n1. After the initial symptom report, patients will have a face-to-face or virtual visit with a clinical pharmacist.\n2. The visit will be tailored based on patient preference and pharmacist judgment.\n3. Pharmacists will discuss symptom reports, provide management recommendations, and coordinate with oncologists for prescriptions if needed.\n4. All interactions will be documented in the electronic health record (EHR) for research analysis.\n\nControl Phase:\n\nBreast cancer patients on AET are typically seen every six months over a 5 to 10-year course, with more frequent visits if complications arise. Control group participants will continue to follow this schedule and receive an FDA document with tips for medication adherence.\n\nConsent Process:\n\nInformed consent will be obtained in person or remotely.",[19,20],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)","Endocrine Therapy",[22,23,24,25],"symptom management","symptom monitoring","pharmacist delivered intervention","oral endocrine therapy adherence","INTERVENTIONAL","SUPPORTIVE_CARE",[29],"NA",{"count":31,"type":32},225,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38},"BEHAVIORAL","Pharmacist delivered symptom monitoring and management","Patients in the intervention phase will receive PRO-based symptom monitoring once a month and pharmacist-led management for problematic symptoms based on routine clinical care recommendations.",[39,40],"Symptom Monitoring and Management first, Then Usual Care","Usual Care first, Then Symptom Monitoring and Management",[42,46],{"measure":43,"description":44,"timeFrame":45},"Medication adherence","Defined as the proportion of total days' pills taken by patients measured by the opening of an electronic pill monitoring cap","From baseline to 12 months",{"measure":47,"description":48,"timeFrame":49},"Intervention durability on medication adherence","Assess the durability of AET adherence 1 year post intervention on patients assigned to the intervention phase first. Defined as the proportion of total days' pills taken by patients measured by the opening of an electronic pill monitoring cap","From 12 to 24 months",[51,53,57,60,63,66,69,72,75,78,81,84,87],{"measure":43,"description":52,"timeFrame":45},"Medication adherence, based on prescription fill data (percent days covered, as used in screening)",{"measure":54,"description":55,"timeFrame":56},"Pain","Patient-report collected via PROMIS Pain Interference measure","From baseline to 24 months",{"measure":58,"description":59,"timeFrame":56},"Fatigue","Patient-report collected via PROMIS Fatigue measure",{"measure":61,"description":62,"timeFrame":56},"Sleep","Patient-report collected via PROMIS Sleep-related Impairment measure",{"measure":64,"description":65,"timeFrame":56},"Anxiety","Patient-report collected via PROMIS Anxiety measure",{"measure":67,"description":68,"timeFrame":56},"Depression","Patient-report collected via PROMIS Depression measure",{"measure":70,"description":71,"timeFrame":56},"Sexual function","Patient-report collected via PROMIS Sexual Function and Satisfaction measure",{"measure":73,"description":74,"timeFrame":56},"Physical functioning","Patient-report collected via PROMIS Physical Functioning measure.",{"measure":76,"description":77,"timeFrame":56},"Social functioning","Patient-report collected via PROMIS Ability to Participate in Social Roles and Activities measure",{"measure":79,"description":80,"timeFrame":56},"Self-efficacy to manage medications","Patient-report collected via PROMIS Self-efficacy to Manage Medications measure",{"measure":82,"description":83,"timeFrame":56},"Self-efficacy to manage symptoms","Patient-report collected via PROMIS Self-efficacy to Manage Symptoms measure",{"measure":85,"description":86,"timeFrame":56},"Social support","Patient-reported collected via PROMIS Instrumental Support measure",{"measure":88,"description":89,"timeFrame":45},"Team-patient communication quality","Team-patient communication quality collected using The Communication Assessment Tool","FEMALE","18 Years",null,false,{"inclusion":95,"exclusion":103,"raw_text":110},[96,97,98,99,100,101,102],"Cisgender women assigned female at birth","Age 18 years or older","Stage 1-3 hormone receptor-positive breast cancer","Recommended to continue AET for ≥2 additional years after enrollment","Low adherence defined as prescription fills with a proportion of days covered (PDC) of \\\u003C80%, examined over all fills during the 2 years prior to date of eligibility review since the first AET prescription\u002Fdata of AET start OR unable to calculate adherence","Verbal fluency in English or Spanish","Ability to understand informed consent and the willingness to sign it",[104,105,106,107,108,109],"Unable to verbalize comprehension of study or impaired decision-making","Known distant metastatic disease","Not receiving breast cancer care or AET prescription from provider at participating site","Evidence that an oncology provider discontinued their AET","Pregnant or trying to get pregnant","Facility-administered medications (i.e., nursing home, home healthcare agency)","Inclusion Criteria:\n\n* Cisgender women assigned female at birth\n* Age 18 years or older\n* Stage 1-3 hormone receptor-positive breast cancer\n\n  1. Premenopausal patients being treated with GNRH agonist\u002Fantagonist to induce menopause are eligible\n  2. Patients who received treatment with CDK 4\u002F6 inhibitors are eligible\n* Recommended to continue AET for ≥2 additional years after enrollment\n* Low adherence defined as prescription fills with a proportion of days covered (PDC) of \\\u003C80%, examined over all fills during the 2 years prior to date of eligibility review since the first AET prescription\u002Fdata of AET start OR unable to calculate adherence\n* Verbal fluency in English or Spanish\n* Ability to understand informed consent and the willingness to sign it\n\nExclusion Criteria:\n\n* Unable to verbalize comprehension of study or impaired decision-making\n* Known distant metastatic disease\n* Not receiving breast cancer care or AET prescription from provider at participating site\n* Evidence that an oncology provider discontinued their AET\n* Pregnant or trying to get pregnant\n* Facility-administered medications (i.e., nursing home, home healthcare agency)",[112,113],"ADULT","OLDER_ADULT",[115,124,132],{"facility":116,"city":117,"state":118,"zip":119,"country":120,"geoPoint":121},"University of Illinois Chicago","Chicago","Illinois","60612","United States",{"lat":122,"lon":123},41.85003,-87.65005,{"facility":125,"city":126,"state":127,"zip":128,"country":120,"geoPoint":129},"Mayo Clinic","Rochester","Minnesota","55905",{"lat":130,"lon":131},44.02163,-92.4699,{"facility":13,"city":133,"state":134,"zip":135,"country":120,"geoPoint":136},"Milwaukee","Wisconsin","26509",{"lat":137,"lon":138},43.0389,-87.90647,[],[],[142],{"pmid":143,"type":144,"citation":145},"35393248","BACKGROUND","Neuner J, Weil E, Fergestrom N, Stolley M, Kamaraju S, Oxencis C, Winn A, Laud PW, Flynn KE. Feasibility of a pharmacist-led symptom monitoring and management intervention to improve breast cancer endocrine therapy adherence. J Am Pharm Assoc (2003). 2022 Jul-Aug;62(4):1321-1328.e3. doi: 10.1016\u002Fj.japh.2022.03.001. Epub 2022 Mar 5.",[],{"nct_id":4,"conditions":148,"biomarkers":150},[149],"Breast Carcinoma",[151],"HR LYSINE DEMETHYLASE AND NUCLEAR RECEPTOR COREPRESSOR",{"nct_id":4,"found":93,"summary":92,"prompt_version":92}]