[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06112613":3,"trial-entities:NCT06112613":3118,"trial-summary:NCT06112613":3122},{"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":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":62,"secondary_outcomes":67,"sex":89,"minimum_age":90,"maximum_age":91,"healthy_volunteers":92,"eligibility_criteria":93,"std_ages":121,"locations":124,"central_contacts":3107,"overall_officials":3108,"references":3112,"see_also_links":3117},"NCT06112613","EAQ221CD","Mobile Health for Adherence in Breast Cancer Patients","Improving Medication Adherence in Breast Cancer Using a CONnected CUstomized Treatment Platform (CONCURxP)","ACTIVE_NOT_RECRUITING","2027-01-31","2026-07","2026-08-19","2024-04-02","ECOG-ACRIN Cancer Research Group","NETWORK",true,"This clinical trial compares the use of the connected customized treatment platform (CONCURxP), consisting of using a medication monitoring device called WiseBag along with text message reminders for missed or extra medication events, to enhanced usual care (EUC), where patients only use the WiseBag, to monitor medication adherence in patients with breast cancer who are taking a CKD4\u002F6 inhibitor. To ensure CDK4\u002F6 inhibitors achieve their full clinical benefit, patients need to take them as prescribed, following a complex treatment schedule. Forgetfulness was the most common reason reported for medication non adherence. Using the WiseBag along with CONCURxP or enhanced usual care may improve medication adherence in patients with breast cancer who are taking a CKD4\u002F6 inhibitor.","PRIMARY OBJECTIVE:\n\nI. To compare CDK4\u002F6 inhibitors (CDK4\u002F6i) adherence at 12 months after randomization captured using electronic monitoring between the EUC (Arm A) and CONCURxP (Arm B) arms.\n\nSECONDARY OBJECTIVES:\n\nI. To compare CDK4\u002F6i adherence at 12 months after randomization captured through self-report between the EUC (Arm A) and CONCURxP (Arm B) arms.\n\nII. To compare CDK4\u002F6i persistence at 12 months after randomization captured using electronic monitoring between the EUC (Arm A) and CONCURxP (Arm B) arms.\n\nIII. To compare symptom burden at 12 months after randomization between the EUC (Arm A) and CONCURxP (Arm B) arms.\n\nIV. To compare quality of life at 12 months after randomization between the EUC (Arm A) and CONCURxP (Arm B) arms.\n\nV. To compare patient-provider communication at 12 months after randomization between the EUC (Arm A) and CONCURxP (Arm B) arms.\n\nVI. To compare self-efficacy for managing symptoms at 12 months after randomization between the EUC (Arm A) and CONCURxP (Arm B) arms.\n\nVII. To compare financial worry at 12 months after randomization between the EUC (Arm A) and CONCURxP (Arm B) arms.\n\nEXPLORATORY OBJECTIVES:\n\nI. To assess longitudinal changes of patient-reported outcomes (self reported adherence, symptom burden, quality of life, and financial worry) from randomization to 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms.\n\nII. To compare healthcare utilization at 12 months after randomization between the EUC (Arm A) and CONCURxP (Arm B) arms.\n\nIII. To describe CONCURxP (Arm B) patients experience with various implementation outcomes.\n\nOUTLINE: Patients are randomized into 1 of 2 arms.\n\nARM A: Patients use the WiseBag medication dispenser and receive access to educational materials every 4 weeks over 12 months.\n\nARM B: Patients use the WiseBag medication dispenser and receive personalized text message reminders, medication tracking and healthcare provider follow ups as part of the CONCURxP platform over 12 months. Patients may complete an interview over 20-30 minutes within 6 months of study completion.\n\nAfter completion of study intervention, patients may be followed up to 6 months.",[19],"Breast Carcinoma",[],"INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[24],"NA",{"count":26,"type":27},390,"ESTIMATED",[29,36,40,45,52,55],{"type":30,"name":31,"description":32,"armGroupLabels":33},"OTHER","Electronic Health Record Review","Ancillary studies",[34,35],"ARM A (Enhanced usual care)","ARM B (CONCURxP program)",{"type":30,"name":37,"description":38,"armGroupLabels":39},"Health Promotion and Education","Receive access to educational materials",[34],{"type":41,"name":42,"description":43,"armGroupLabels":44},"PROCEDURE","Health Telemonitoring","Utilize the WiseBag medication dispenser",[34,35],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"BEHAVIORAL","Patient Navigation","Receive healthcare provider follow ups as part of the CONCURxP program",[35],[51],"Patient Navigator Program",{"type":30,"name":53,"description":32,"armGroupLabels":54},"Survey Administration",[34,35],{"type":30,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"Text Message-Based Navigation Intervention","Receive personalized text message reminders related to their medication tracking as part of the CONCURxP program",[35],[60,61],"Automated Text Message-Based Navigation","Text Message-Based Navigation",[63],{"measure":64,"description":65,"timeFrame":66},"Adherence using electronic monitoring","For each arm, mean and standard deviation (SD) adherence rates for all patients will be calculated. A two-sample t-test will be used to compare CDK4\u002F6 inhibitor (CDK4\u002F6i) adherence between the two arms at 12 months.","At 12 months after randomization",[68,71,74,77,80,83,86],{"measure":69,"description":70,"timeFrame":66},"Adherence using self-report","Using the12-item Patient Reported Outcomes Measurement Information System (PROMIS) Medication Adherence Scale compare mean score and changes in mean scores (from baseline) at each time point between the arms using two-sample t-tests.",{"measure":72,"description":73,"timeFrame":66},"CDK4\u002F6i persistence","Defined as duration from randomization to discontinuation of medication against medical advice, measured as the number of days from randomization until the first day of a gap that is 30 days or longer. For each arm, mean days of persistence, and the proportion of patients who discontinue the medication earlier than 12-month will be calculated and compared between the two arms using the two-sample t-test and chi-squared test, respectively.",{"measure":75,"description":76,"timeFrame":66},"Symptom burden","Using the 16-item National-Comprehensive Cancer Network Functional Assessment of Cancer Therapy Breast Cancer Symptom index compare mean score and changes in mean scores (from baseline) at each time point between the arms using two-sample t-tests.",{"measure":78,"description":79,"timeFrame":66},"Quality of life","Using the PROMIS-10- version (v)1.2-Global Health compare mean score and changes in mean scores (from baseline) at each time point between the arms using two-sample t-tests.",{"measure":81,"description":82,"timeFrame":66},"Patient-provider communication","Using the Consumer Assessment of Healthcare Providers and Systems compare mean score and changes in mean scores (from baseline) at each time point between the arms using two-sample t-tests.",{"measure":84,"description":85,"timeFrame":66},"Self-efficacy for managing symptoms","Using PROMIS Item Bank v1.0 - Self-Efficacy for Managing Symptoms compare mean score and changes in mean scores (from baseline) at each time point between the arms using two-sample t-tests.",{"measure":87,"description":88,"timeFrame":66},"Financial worry","Using the Comprehensive Score for Financial Toxicity compare mean score and changes in mean scores (from baseline) at each time point between the arms using two-sample t-tests.","ALL","18 Years",null,false,{"inclusion":94,"exclusion":119,"raw_text":120},[95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118],"PATIENT STEP 0: Patient must be \\>= 18 years of age","PATIENT STEP 0: Patient must be fluent in written and spoken English OR patient must be fluent in written and spoken Spanish","PATIENT STEP 0: Patient must present with new or established breast cancer at the time of Step 0","PATIENT STEP 0: Patient must have initiated any of the CKD4\u002F6 inhibitors (palbociclib or Ibrance, ribociclib or Kisqali, abemaciclib or Verzenio) within 60 days prior to registration to Step 0 or have received a prescription order with stated intent to initiate within 30 days following registration to Step 0","NOTE: Patients who have been treated previously with anticancer treatments other than CDK4\u002F6 inhibitors are eligible","NOTE: CDK4\u002F6 inhibitors must be provided\u002Fsupplied as a single agent blister pack. If the medication is supplied as capsules in a pill bottle (e.g., Ibrance capsules), patient is not eligible","NOTE: Ribociclib (Kisqali) and abemaciclib (Verzenio) are only available in blister packs. Palbociclib (Ibrance) is the only CDK4\u002F6 inhibitor that might be available in a capsule formulation. However, this is an outdated formulation and is rarely prescribed as a new start. The format of ordered palbociclib can be determined based on the prescription order","PATIENT STEP 0: Patient must not have been previously treated with any of the following CDK4\u002F6 inhibitors: Palbociclib or Ibrance, ribociclib or Kisqali, and abemaciclib or Verzenio","PATIENT STEP 0: Patient must not already be enrolled in a therapeutic clinical trial that monitors CDK4\u002F6 inhibitors","PATIENT STEP 0: Patient must not be enrolled in a symptom science clinical trial that monitors or intervenes on symptoms related to CDK4\u002F6 inhibitors","NOTE: If NRG-CC012CD is activated in a participating practice, and a patient meets the eligibility criteria for both EAQ221CD and NRG-CC012CD, then EAQ221CD should be offered first to patients. Only if a patient is not eligible or not interested in participating in EAQ221CD, the NRG-CC012CD can be offered","PATIENT STEP 0: Patient must confirm that they intend to receive their care or monitoring at a National Cancer Institute Community Oncology Research Program (NCORP) site or one of the following two NCI designated Comprehensive Cancer Centers: Emory University Winship Cancer Institute or University of California Irvine Chao Family Comprehensive Cancer Center","PATIENT STEP 0: Patient must have either a personal smartphone in which they agree to receive text messages or an email address in addition to a non-smart mobile phone in which they agree to receive text messages","NOTE: Since mobile phones that are not smart phones cannot follow web links in a text message, people with non-smart mobile phones will also need an email address","PATIENT STEP 0: Patient must have the ability to understand and the willingness to sign a written informed consent document","NOTE: Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available are not eligible","PATIENT STEP 0: Patient must not have an Eastern Cooperative Oncology Group (ECOG) performance status \\>= 3 OR patient must not be deemed medically unable to participate in the study by the study investigators or an oncology clinician (i.e., referral to hospice)","PATIENT STEP 0: Patient must not be enrolled in other trials offering financial assistance","NOTE: Gift cards for survey completion, parking passes, or free medication provided as part of therapeutic trials are not considered financial assistance","PATIENT STEP 1: Patient must meet all the eligibility criteria for step 0","PATIENT STEP 1: Patient must have signed a written informed consent form","PATIENT STEP 1: Patient must have completed baseline survey within 30 days after Oncology Patient Enrollment Network (OPEN) screening registration (step 0)","PATIENT STEP 1: Patients must have initiated their CDK 4\u002F6 inhibitors either 60 days prior to or 30 days after the date of OPEN Screening Registration (Step 0)","PATIENT STEP 1: Step 1 registration must occur within 45 days of Step 0 registration",[],"Inclusion Criteria:\n\n* PATIENT STEP 0: Patient must be \\>= 18 years of age\n* PATIENT STEP 0: Patient must be fluent in written and spoken English OR patient must be fluent in written and spoken Spanish\n* PATIENT STEP 0: Patient must present with new or established breast cancer at the time of Step 0\n* PATIENT STEP 0: Patient must have initiated any of the CKD4\u002F6 inhibitors (palbociclib or Ibrance, ribociclib or Kisqali, abemaciclib or Verzenio) within 60 days prior to registration to Step 0 or have received a prescription order with stated intent to initiate within 30 days following registration to Step 0\n\n  * NOTE: Patients who have been treated previously with anticancer treatments other than CDK4\u002F6 inhibitors are eligible\n  * NOTE: CDK4\u002F6 inhibitors must be provided\u002Fsupplied as a single agent blister pack. If the medication is supplied as capsules in a pill bottle (e.g., Ibrance capsules), patient is not eligible\n  * NOTE: Ribociclib (Kisqali) and abemaciclib (Verzenio) are only available in blister packs. Palbociclib (Ibrance) is the only CDK4\u002F6 inhibitor that might be available in a capsule formulation. However, this is an outdated formulation and is rarely prescribed as a new start. The format of ordered palbociclib can be determined based on the prescription order\n* PATIENT STEP 0: Patient must not have been previously treated with any of the following CDK4\u002F6 inhibitors: Palbociclib or Ibrance, ribociclib or Kisqali, and abemaciclib or Verzenio\n* PATIENT STEP 0: Patient must not already be enrolled in a therapeutic clinical trial that monitors CDK4\u002F6 inhibitors\n* PATIENT STEP 0: Patient must not be enrolled in a symptom science clinical trial that monitors or intervenes on symptoms related to CDK4\u002F6 inhibitors\n\n  * NOTE: If NRG-CC012CD is activated in a participating practice, and a patient meets the eligibility criteria for both EAQ221CD and NRG-CC012CD, then EAQ221CD should be offered first to patients. Only if a patient is not eligible or not interested in participating in EAQ221CD, the NRG-CC012CD can be offered\n* PATIENT STEP 0: Patient must confirm that they intend to receive their care or monitoring at a National Cancer Institute Community Oncology Research Program (NCORP) site or one of the following two NCI designated Comprehensive Cancer Centers: Emory University Winship Cancer Institute or University of California Irvine Chao Family Comprehensive Cancer Center\n* PATIENT STEP 0: Patient must have either a personal smartphone in which they agree to receive text messages or an email address in addition to a non-smart mobile phone in which they agree to receive text messages\n\n  * NOTE: Since mobile phones that are not smart phones cannot follow web links in a text message, people with non-smart mobile phones will also need an email address\n* PATIENT STEP 0: Patient must have the ability to understand and the willingness to sign a written informed consent document\n\n  * NOTE: Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available are not eligible\n* PATIENT STEP 0: Patient must not have an Eastern Cooperative Oncology Group (ECOG) performance status \\>= 3 OR patient must not be deemed medically unable to participate in the study by the study investigators or an oncology clinician (i.e., referral to hospice)\n* PATIENT STEP 0: Patient must not be enrolled in other trials offering financial assistance\n\n  * NOTE: Gift cards for survey completion, parking passes, or free medication provided as part of therapeutic trials are not considered financial assistance\n* PATIENT STEP 1: Patient must meet all the eligibility criteria for step 0\n* PATIENT STEP 1: Patient must have signed a written informed consent form\n* PATIENT STEP 1: Patient must have completed baseline survey within 30 days after Oncology Patient Enrollment Network (OPEN) screening registration (step 0)\n* PATIENT STEP 1: Patients must have initiated their CDK 4\u002F6 inhibitors either 60 days prior to or 30 days after the date of OPEN Screening Registration (Step 0)\n* PATIENT STEP 1: Step 1 registration must occur within 45 days of Step 0 registration",[122,123],"ADULT","OLDER_ADULT",[125,134,142,149,157,164,171,179,186,189,196,203,210,213,220,227,234,241,248,252,259,266,273,280,287,294,301,308,315,319,326,333,340,347,354,361,368,376,383,387,394,401,404,408,415,419,423,426,429,433,440,443,450,453,456,463,470,473,480,487,490,497,500,507,514,521,529,536,543,546,550,557,564,572,580,588,595,599,603,610,617,624,631,634,638,645,652,660,667,674,681,688,695,702,709,717,723,727,734,741,748,755,762,769,776,783,790,797,800,807,814,821,824,831,835,842,849,856,864,872,875,882,889,896,899,906,913,920,924,931,938,945,952,959,967,974,981,989,996,1003,1006,1010,1017,1024,1031,1039,1042,1046,1053,1060,1067,1070,1074,1081,1085,1093,1101,1108,1115,1119,1126,1133,1136,1143,1146,1153,1160,1163,1170,1173,1180,1184,1191,1198,1201,1204,1207,1214,1221,1224,1227,1233,1236,1239,1246,1253,1256,1260,1264,1271,1278,1285,1288,1295,1302,1309,1316,1323,1330,1336,1343,1346,1349,1352,1359,1366,1370,1377,1380,1387,1394,1401,1408,1412,1415,1418,1421,1428,1435,1441,1445,1453,1460,1467,1474,1481,1488,1495,1501,1504,1511,1518,1525,1532,1535,1538,1545,1548,1555,1562,1569,1576,1583,1586,1593,1596,1603,1607,1611,1618,1625,1632,1639,1646,1653,1660,1667,1674,1681,1685,1692,1699,1706,1713,1720,1727,1734,1741,1748,1755,1761,1769,1776,1783,1790,1797,1804,1811,1819,1826,1833,1840,1847,1850,1857,1864,1867,1873,1880,1884,1891,1895,1899,1906,1914,1921,1928,1935,1938,1945,1952,1959,1966,1974,1981,1988,1995,1999,2003,2010,2018,2025,2028,2031,2035,2038,2041,2044,2047,2053,2057,2060,2064,2068,2071,2075,2079,2082,2085,2089,2093,2096,2099,2102,2105,2108,2111,2115,2119,2122,2125,2129,2133,2136,2140,2147,2154,2158,2162,2170,2177,2184,2191,2198,2206,2214,2221,2228,2231,2235,2242,2250,2257,2264,2272,2279,2282,2285,2289,2293,2296,2303,2311,2318,2325,2332,2336,2340,2344,2348,2355,2362,2365,2368,2375,2382,2385,2392,2396,2403,2409,2416,2424,2432,2438,2446,2453,2460,2466,2473,2480,2487,2490,2497,2504,2510,2517,2525,2531,2534,2541,2549,2553,2561,2568,2575,2582,2585,2592,2595,2601,2608,2615,2619,2626,2632,2636,2640,2644,2648,2655,2662,2669,2676,2683,2690,2698,2702,2709,2712,2719,2726,2733,2740,2747,2754,2761,2767,2770,2777,2784,2791,2795,2799,2806,2809,2816,2823,2830,2837,2844,2851,2855,2859,2863,2866,2870,2877,2884,2891,2898,2905,2912,2919,2922,2925,2932,2936,2943,2950,2957,2960,2963,2970,2977,2984,2987,2994,3001,3008,3015,3022,3025,3032,3039,3046,3053,3056,3063,3070,3078,3082,3089,3096,3100,3103],{"facility":126,"city":127,"state":128,"zip":129,"country":130,"geoPoint":131},"Fairbanks Memorial Hospital","Fairbanks","Alaska","99701","United States",{"lat":132,"lon":133},64.83778,-147.71639,{"facility":135,"city":136,"state":137,"zip":138,"country":130,"geoPoint":139},"Kingman Regional Medical Center","Kingman","Arizona","86401",{"lat":140,"lon":141},35.18944,-114.05301,{"facility":143,"city":144,"state":137,"zip":145,"country":130,"geoPoint":146},"Cancer Center at Saint Joseph's","Phoenix","85004",{"lat":147,"lon":148},33.44838,-112.07404,{"facility":150,"city":151,"state":152,"zip":153,"country":130,"geoPoint":154},"Mercy Hospital Fort Smith","Fort Smith","Arkansas","72903",{"lat":155,"lon":156},35.38592,-94.39855,{"facility":158,"city":159,"state":152,"zip":160,"country":130,"geoPoint":161},"NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro","Jonesboro","72401",{"lat":162,"lon":163},35.8423,-90.70428,{"facility":165,"city":166,"state":152,"zip":167,"country":130,"geoPoint":168},"CARTI Cancer Center","Little Rock","72205",{"lat":169,"lon":170},34.74648,-92.28959,{"facility":172,"city":173,"state":174,"zip":175,"country":130,"geoPoint":176},"Kaiser Permanente-Anaheim","Anaheim","California","92806",{"lat":177,"lon":178},33.83529,-117.9145,{"facility":180,"city":181,"state":174,"zip":182,"country":130,"geoPoint":183},"Mission Hope Medical Oncology - Arroyo Grande","Arroyo Grande","93420",{"lat":184,"lon":185},35.11859,-120.59073,{"facility":187,"city":181,"state":174,"zip":182,"country":130,"geoPoint":188},"PCR Oncology",{"lat":184,"lon":185},{"facility":190,"city":191,"state":174,"zip":192,"country":130,"geoPoint":193},"Kaiser Permanente-Baldwin Park","Baldwin Park","91706",{"lat":194,"lon":195},34.08529,-117.9609,{"facility":197,"city":198,"state":174,"zip":199,"country":130,"geoPoint":200},"Kaiser Permanente-Bellflower","Bellflower","90706",{"lat":201,"lon":202},33.88168,-118.11701,{"facility":204,"city":205,"state":174,"zip":206,"country":130,"geoPoint":207},"Mercy Cancer Center - Carmichael","Carmichael","95608",{"lat":208,"lon":209},38.61713,-121.32828,{"facility":211,"city":205,"state":174,"zip":206,"country":130,"geoPoint":212},"Mercy San Juan Medical Center",{"lat":208,"lon":209},{"facility":214,"city":215,"state":174,"zip":216,"country":130,"geoPoint":217},"Mercy Cancer Center - Elk Grove","Elk Grove","95758",{"lat":218,"lon":219},38.4088,-121.37162,{"facility":221,"city":222,"state":174,"zip":223,"country":130,"geoPoint":224},"Kaiser Permanente-Fontana","Fontana","92335",{"lat":225,"lon":226},34.09223,-117.43505,{"facility":228,"city":229,"state":174,"zip":230,"country":130,"geoPoint":231},"Kaiser Permanente South Bay","Harbor City","90710",{"lat":232,"lon":233},33.79002,-118.29785,{"facility":235,"city":236,"state":174,"zip":237,"country":130,"geoPoint":238},"Kaiser Permanente-Irvine","Irvine","92618",{"lat":239,"lon":240},33.66946,-117.82311,{"facility":242,"city":243,"state":174,"zip":244,"country":130,"geoPoint":245},"Kaiser Permanente Los Angeles Medical Center","Los Angeles","90027",{"lat":246,"lon":247},34.05223,-118.24368,{"facility":249,"city":243,"state":174,"zip":250,"country":130,"geoPoint":251},"Kaiser Permanente West Los Angeles","90034",{"lat":246,"lon":247},{"facility":253,"city":254,"state":174,"zip":255,"country":130,"geoPoint":256},"Contra Costa Regional Medical Center","Martinez","94553-3156",{"lat":257,"lon":258},38.01937,-122.13413,{"facility":260,"city":261,"state":174,"zip":262,"country":130,"geoPoint":263},"Mercy Cancer Center","Merced","95340",{"lat":264,"lon":265},37.30216,-120.48297,{"facility":267,"city":268,"state":174,"zip":269,"country":130,"geoPoint":270},"Kaiser Permanente-Ontario","Ontario","91761",{"lat":271,"lon":272},34.06334,-117.65089,{"facility":274,"city":275,"state":174,"zip":276,"country":130,"geoPoint":277},"UC Irvine Health\u002FChao Family Comprehensive Cancer Center","Orange","92868",{"lat":278,"lon":279},33.78779,-117.85311,{"facility":281,"city":282,"state":174,"zip":283,"country":130,"geoPoint":284},"Kaiser Permanente - Panorama City","Panorama City","91402",{"lat":285,"lon":286},34.22473,-118.44981,{"facility":288,"city":289,"state":174,"zip":290,"country":130,"geoPoint":291},"Kaiser Permanente-Riverside","Riverside","92505",{"lat":292,"lon":293},33.95335,-117.39616,{"facility":295,"city":296,"state":174,"zip":297,"country":130,"geoPoint":298},"Mercy Cancer Center - Rocklin","Rocklin","95765",{"lat":299,"lon":300},38.79073,-121.23578,{"facility":302,"city":303,"state":174,"zip":304,"country":130,"geoPoint":305},"Mercy Cancer Center - Sacramento","Sacramento","95816",{"lat":306,"lon":307},38.58157,-121.4944,{"facility":309,"city":310,"state":174,"zip":311,"country":130,"geoPoint":312},"Kaiser Permanente-San Diego Mission","San 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Rico",{"lat":3076,"lon":3077},18.39856,-66.15572,{"facility":3079,"city":3072,"zip":3080,"country":3074,"geoPoint":3081},"Puerto Rico Hematology Oncology Group","00961",{"lat":3076,"lon":3077},{"facility":3083,"city":3084,"zip":3085,"country":3074,"geoPoint":3086},"Doctors Cancer Center","Manati","00674",{"lat":3087,"lon":3088},18.42745,-66.49212,{"facility":3090,"city":3091,"zip":3092,"country":3074,"geoPoint":3093},"San Juan Community Oncology Group","San Juan","00917",{"lat":3094,"lon":3095},18.46633,-66.10572,{"facility":3097,"city":3091,"zip":3098,"country":3074,"geoPoint":3099},"Centro Comprensivo de Cancer de UPR","00927",{"lat":3094,"lon":3095},{"facility":3101,"city":3091,"zip":3098,"country":3074,"geoPoint":3102},"PROncology",{"lat":3094,"lon":3095},{"facility":3104,"city":3091,"zip":3105,"country":3074,"geoPoint":3106},"San Juan City Hospital","00936",{"lat":3094,"lon":3095},[],[3109],{"name":3110,"affiliation":13,"role":3111},"Gelareh Sadigh","PRINCIPAL_INVESTIGATOR",[3113],{"pmid":3114,"type":3115,"citation":3116},"41265834","DERIVED","Sadigh G, Duan F, Gareen IF, Hancock J, Sicks JD, Thangarajah M, Meisel JL, Torres MA, Ramsey SD, Wolff AC, Wagner LI, Carlos RC, Graetz I. Improving CDK4\u002F6 inhibitors adherence in breast cancer using the CONnected CUstomized Treatment Platform (CONCURxP) mobile health intervention: Study protocol for ECOG-ACRIN EAQ221CD. Contemp Clin Trials. 2026 Jan;160:108145. doi: 10.1016\u002Fj.cct.2025.108145. Epub 2025 Nov 18.",[],{"nct_id":4,"conditions":3119,"biomarkers":3120},[19],[3121],"ESR1 Gene",{"nct_id":4,"found":15,"summary":3123,"prompt_version":3132},{"design":3124,"status":3125,"heading":6,"summary":3126,"follow_up":3127,"word_count":3128,"commitments":3129,"compensation":3130,"drugs_mentioned":3131},"This is an interventional study comparing two ways to help patients take their medication. It plans to enroll 410 participants, who are oncology healthcare providers.","completed","This study is looking at how a mobile health system can help patients with metastatic breast cancer (cancer that has spread to other parts of the body) take their CDK4\u002F6 inhibitor medication as prescribed. You would either use a medication monitoring device called WiseBag along with text message reminders (CONCURxP group) or just the WiseBag device (enhanced usual care group). The main goal is to see if the CONCURxP system helps patients stick to their medication schedule better over 12 months. This study is for oncology healthcare providers who have cared for patients with less than 85% adherence to their medication.","The study measures medication adherence at 12 months after medication initiation.",101,"You would participate in an interview and receive educational materials. You would also receive healthcare provider follow-ups as part of the CONCURxP program.","Not stated in the trial record.",[],"v2"]