{"doi":"10.1016/j.cct.2025.108145","title":"Improving CDK4/6 inhibitors adherence in breast cancer using the CONnected CUstomized Treatment Platform (CONCURxP) mobile health intervention: Study protocol for ECOG-ACRIN EAQ221CD","abstract":"BACKGROUND: Cyclin-dependent kinase 4/6 inhibitors (CDKIs) improves survival when added to endocrine therapy in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. However, their complex schedule, side effects, and cost contribute to non-adherence. METHODS: The EAQ221CD is a two-arm randomized controlled trial that evaluates the effectiveness of the CONnected CUstomized Treatment Platform (CONCURxP), a mobile health intervention, versus enhanced usual care (EUC) on CDKI adherence among 390 patients with breast cancer and a new CDKI prescription. Participants use a smart pouch (Wisebag) to monitor real-time adherence. CONCURxP arm patients: (1) receive text reminders for missed or extra doses; (2) receive text message surveys inquiring reasons for missed or extra doses; and (3) have access to their adherence history on a study web portal. Missed or double doses trigger alerts to the oncology team. Patients citing cost as a barrier are referred to a national non-profit financial navigation program. EUC arm patients receive educational materials on side effect management. Patients complete surveys at baseline, 3, 6, and 12 months after randomization. Our objectives are to: (1) compare 12-month CDKI adherence measured using Wisebag (primary outcome) between the two arms; (2) compare patient-reported outcomes at 12-months between the two arms, including symptom burden, quality of life, patient-provider communication, self-efficacy for managing symptoms, and financial worry; and (3) use mixed methods to describe patients' experience with the CONCURxP intervention. Our multilevel intervention will provide actionable results to improve adherence, health outcomes, and patients' experience. TRIAL REGISTRATION: NCT06112613.","journal":"Contemporary Clinical Trials","year":2025,"id":537230,"datarank":0.10397207708399181,"base_score":0.6931471805599453,"endowment":0.6931471805599453,"self_citation_contribution":0.10397207708399181,"citation_network_contribution":0.0,"self_endowment_contribution":0.10397207708399181,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":1,"citer_count":1,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.951,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT06112613"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2025-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":385666,"name":"Fenghai Duan","orcid":"0000-0002-5084-0070","position":1,"is_corresponding":false},{"id":562897,"name":"Ilana F. Gareen","orcid":"0000-0002-0457-5595","position":2,"is_corresponding":false},{"id":817437,"name":"Judy Hancock","orcid":null,"position":3,"is_corresponding":false},{"id":817434,"name":"JoRean D. Sicks","orcid":null,"position":4,"is_corresponding":false},{"id":1045791,"name":"Maryanne Thangarajah","orcid":null,"position":5,"is_corresponding":false},{"id":444965,"name":"Jane Meisel","orcid":"0000-0002-2642-865X","position":6,"is_corresponding":false},{"id":444967,"name":"Mylin A. Torres","orcid":"0000-0003-3582-5216","position":7,"is_corresponding":false},{"id":355457,"name":"Scott D. Ramsey","orcid":"0000-0001-5972-8280","position":8,"is_corresponding":false},{"id":500900,"name":"Antonio C. Wolff","orcid":"0000-0003-3734-1063","position":9,"is_corresponding":false},{"id":5119,"name":"Lynne I. Wagner","orcid":"0000-0001-9685-4796","position":10,"is_corresponding":false},{"id":280774,"name":"Ruth C. Carlos","orcid":"0000-0001-7055-7662","position":11,"is_corresponding":false},{"id":767883,"name":"Ilana Graetz","orcid":"0000-0003-3664-5815","position":12,"is_corresponding":false},{"id":574694,"name":"Gelareh Sadigh","orcid":"0000-0003-3233-1878","position":0,"is_corresponding":true}],"reference_count":49,"raw_metadata":null,"created_at":"2026-07-19T02:52:12.997494Z","pmid":"41265834","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}