[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06121453":3,"trial-entities:NCT06121453":99,"trial-summary:NCT06121453":103},{"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":35,"secondary_outcomes":40,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":59,"eligibility_criteria":60,"std_ages":72,"locations":75,"central_contacts":90,"overall_officials":96,"references":97,"see_also_links":98},"NCT06121453","AAAU9129","Adherence Intervention in Patients With Metastatic Breast Cancer","P50 Supplement: Improving Medications Adherence Equitably Among Patients With Metastatic Breast Cancer and Cardiovascular Disease","RECRUITING","2026-12-10","2026-07","2026-07-28","2024-04-12","Columbia University","OTHER",true,"To evaluate the preliminary efficacy of a multicomponent adherence intervention focused on enhancing digital equity and pharmaco-equity among nonadherent patients with metastatic breast cancer (MBC) and cardiovascular disease (CVD) risk factors on endocrine therapy (ET), CDK4\u002F6 inhibitor (CDK 4\u002F6i), and CVD medications. To assess the acceptability and appropriateness of this intervention in patients with MBC and CVD risk factors through validated measures of implementation outcomes. To gain a deeper understanding of the impact of social determinants of health (SDOH) on medication nonadherence through semi-structured interviews with a subset of study participants.",null,[19],"Breast Cancer",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[24],"NA",{"count":26,"type":27},35,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","Multicomponent Adherence Intervention","multi-part intervention to reduce barriers to medication use",[34],"Single Arm: Adherence Intervention",[36],{"measure":37,"description":38,"timeFrame":39},"Number of Participants on multicomponent adherence intervention","To determine the preliminary efficacy of a multicomponent adherence intervention that targets digital and pharmaco-equity among patients with metastatic breast cancer with at least some nonadherence to endocrine therapy, CDK4\u002F6 inhibitor, and\u002For at least one oral cardiovascular disease (CVD) medication (either blood pressure or statin medication), based on its impact on concurrent adherence to endocrine therapy, CDK4\u002F6 inhibitor, and to CVD medication at 28 weeks (or at time of progression of MBC, if prior to 28-week timepoint), assessed by a combination of self-report using the Voils DOSE Nonadherence measure and pharmacy fill data using pharmacy dispensing records available in the Electronic Health Record (EHR).","at 28 weeks",[41,44,47,50,53],{"measure":42,"description":43,"timeFrame":39},"Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at 28 weeks","Healthcare related quality of life (HRQOL), measured by the Patient-Reported Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) measuring health-related quality of life. Raw scores (range 1-5 for each question) are translated into T-scores for each domain (physical function, depression, pain intensity, etc) so that the values follow a normal distribution with a population mean T-score of 50 and a standard deviation of 10. Higher scores can mean better or worse outcomes depending on the domain reported.\n\nOutcomes Measurement Information System (PROMIS)-29.",{"measure":45,"description":46,"timeFrame":39},"Digital Health Literacy Scale","A measure of the basic skills necessary for using digital health services, as assessed by a 3-item questionnaire (questions from the Health Information National Trend Survey (HINTS). Scores range with a higher score indicating better level of literacy.(Health Information National Trend Survey). To score the 3-item digital health care literacy scale, we used a sum score of all the items (range 0-4 for each item, sum score range 0-12) such that higher scores indicated higher digital health care literacy.",{"measure":48,"description":49,"timeFrame":39},"Number in using the Voils DOSE Nonadherence measure","Number of and intensity of reasons for nonadherence using the Voils DOSE Nonadherence measure (note: reasons include side-effects and perceived need for medications).",{"measure":51,"description":52,"timeFrame":39},"Changes in Medical Adherence Self-Efficacy Scale (MASES) at 28 Weeks","Self-efficacy with medication regimen, as measured by the Medical Adherence Self- Efficacy Scale (MASES-R). The Medication Adherence Self-Efficacy Scale (MASES). Each question from the 12-item measure is score from 1-4, and the total score for this scale is calculated as the average score of all the items, such that the minimal total score is 1 and the maximal total score is 4. Higher scores indicate higher medication adherence self-efficacy.",{"measure":54,"description":55,"timeFrame":39},"total number of medications and number of doses per day","Medications and regimen complexity","ALL","18 Years","99 Years",false,{"inclusion":61,"exclusion":66,"raw_text":71},[62,63,64,65],"Women or men age \\>18 years","Diagnosed with stage IV\u002Fmetastatic breast cancer prescribed endocrine therapy and a CDK4\u002F6i","Prescribed at least 1 antihypertensive or statin medication for CVD prevention or treatment","Self-report of at least some nonadherence ET\u002FCDK4\u002F6i or CVD medication on nonadherence screener or verbally to a treating clinician, or nonadherent to ET, CDK4\u002F6i, and\u002For CVD medication on pharmacy fill data in the EHR (proportion of days covered over prior 180 days \\\u003C80%).",[67,68,69,70],"Non-English or Non-Spanish speaking","Not cognitively able to complete study requirements","Inability to provide informed consent for any other reason (e.g, severe psychiatric illness, active substance use)","Unavailable for 28 weeks of follow-up","Inclusion Criteria:\n\n* Women or men age \\>18 years\n* Diagnosed with stage IV\u002Fmetastatic breast cancer prescribed endocrine therapy and a CDK4\u002F6i\n* Prescribed at least 1 antihypertensive or statin medication for CVD prevention or treatment\n* Self-report of at least some nonadherence ET\u002FCDK4\u002F6i or CVD medication on nonadherence screener or verbally to a treating clinician, or nonadherent to ET, CDK4\u002F6i, and\u002For CVD medication on pharmacy fill data in the EHR (proportion of days covered over prior 180 days \\\u003C80%).\n\nExclusion Criteria:\n\n* Non-English or Non-Spanish speaking\n* Not cognitively able to complete study requirements\n* Inability to provide informed consent for any other reason (e.g, severe psychiatric illness, active substance use)\n* Unavailable for 28 weeks of follow-up",[73,74],"ADULT","OLDER_ADULT",[76],{"facility":77,"status":8,"city":78,"state":78,"zip":79,"country":80,"contacts":81,"geoPoint":87},"Columbia University Medical Center","New York","10032","United States",[82],{"name":83,"role":84,"phone":85,"email":86},"Claire Sathe, MD","CONTACT","212-305-8923","ds1099@cumc.columbia.edu",{"lat":88,"lon":89},40.71427,-74.00597,[91,95],{"name":92,"role":84,"phone":93,"email":94},"Research Nurse Navigator","212-342-5162","cancerclinicaltrials@cumc.columbia.edu",{"name":83,"role":84,"phone":85,"email":86},[],[],[],{"nct_id":4,"conditions":100,"biomarkers":102},[101],"Breast Carcinoma",[],{"nct_id":4,"found":15,"summary":104,"prompt_version":114},{"design":105,"status":106,"heading":107,"summary":108,"follow_up":109,"word_count":110,"commitments":111,"compensation":112,"drugs_mentioned":113},"This is an interventional study, meaning participants will receive a specific intervention. It plans to enroll 35 participants.","completed","Adherence Intervention for Metastatic Breast Cancer","This study is testing a multi-part intervention to help patients with metastatic breast cancer (cancer that has spread) better stick to their prescribed medications. This includes endocrine therapy (ET), CDK4\u002F6 inhibitors (CDK4\u002F6i), and medications for heart disease risk factors like high blood pressure or cholesterol. The study aims to understand if this intervention helps patients take their medicines as prescribed and how well it works for them. You might be able to join if you are 18 or older, have metastatic breast cancer, are taking ET and a CDK4\u002F6i, are also taking medication for heart disease prevention, and have reported some difficulty taking your medications. The study will measure how many participants are using the intervention after 28 weeks. The current status of the study is unclear, and it plans to enroll 35 people.","Participants will be assessed at 28 weeks to see how many are on the multicomponent adherence intervention.",134,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]