[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100357351":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":41,"studyPopulation":30,"armGroups":42,"interventions":53,"overallOfficials":59,"centralContacts":63,"locations":68,"responsibleParty":86,"collaborators":30,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":30,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":30,"enrollmentInfo":98,"targetDuration":30,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":71,"whyStopped":30,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Northwestern University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":30,"otherOutcomes":30},[9,13,17,20,23,26],{"measure":10,"description":11,"timeFrame":12},"Technical Difficulties","Number of technical glitches and errors experienced in implementing the intervention","28-day intervention period",{"measure":14,"description":15,"timeFrame":16},"Retention Rate","Number of AYA (and caregiver) subjects who complete the intervention, out of the total number of subjects enrolled in the study (target of 75% or more)","Up to 12 months",{"measure":18,"description":19,"timeFrame":16},"Screening Rate","Number of AYA patients (and matched caregivers) referred and screened for the study",{"measure":21,"description":22,"timeFrame":12},"Intervention Engagement","Number of 1) viewed and 2) acknowledged micro-randomized text messages",{"measure":24,"description":25,"timeFrame":16},"Recruitment Rate","Number of AYA patients (and matched caregivers) enrolled in the study out of those who were eligible and invited to participate (target of 75% or more)",{"measure":27,"description":28,"timeFrame":29},"Intervention Acceptability","5-point numerical Likert scale; ranging from 0 (not at all) to 4 (completely) to rate intervention acceptability (including satisfaction, appropriateness, perceived positive effects, potential for future use).","At completion of 28-day intervention period",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":34,"primaryPurpose":35,"observationalModel":30,"timePerspective":30,"maskingInfo":36},"RANDOMIZED","PARALLEL","This study involve a 28-day micro-randomized pilot trial (i.e., a sequential factorial design) of a just-in-time adaptive intervention called ADAPTS ADAPTS is an app that will deliver contextually-tailored mobile messages (adapted to current states, such as mood, pain, and location) designed to promote oral chemotherapy adherence. Each AYA in the study (planned n=30) will be micro-randomized (with a 60% probability) to receive a contextually-tailored message each day that supports abilities to self-manage and maintain adherence, delivered prior to their scheduled dose, over a 28-day period (i.e., the period between follow-up appointments). The remaining 40% of days, participants will be assigned to receive no messages (i.e., no intervention).\n\nWe will also request, but not require, that a caregiver enrolls in the study and pilots the caregiver version of the app (planned n=30 caregivers). The caregiver app does not include any micro-randomization.","SUPPORTIVE_CARE",{"masking":37,"maskingDescription":30,"whoMasked":38},"DOUBLE",[39,40],"PARTICIPANT","INVESTIGATOR","This is two-month study involving a 28-day run-in period (no intervention), followed by a 28-day micro-randomized pilot trial (i.e., a sequential factorial design) of a just-in-time adaptive intervention (JITAI) called ADAPTS (ADherence Assessments and Personalized Timely Support). ADAPTS is an app that integrates contextually-tailored mobile messages designed to promote adherence to an oral chemotherapy called 6-mercaptopurine (6-MP). Participants in the study will electronically-monitor 6-MP adherence with eCAPs for 28 days (approximately one month to establish baseline adherence before introducing the intervention). On approximately Day 29, they will download and use the app while continuing to monitor their adherence for the next 28 days. ADAPTS is an app that is available for Android and Apple devices, and has an Adolescent\u002FYoung Adult (AYA) version (i.e., the primary user) and a Caregiver version. ADAPTS delivers ecological momentary assessment (EMA) surveys each afternoon to AYAs and caregivers, at the same time prior to the evening 6-MP dose, for the 28-day period. Based on EMA responses, ADAPTS sends contextually-tailored mobile messages to AYAs (e.g., based on self-reported fatigue, mood) and objective data (e.g., weekend vs. weekday). After receiving a contextually-tailored message, AYAs will be asked to acknowledge receipt of the message by pressing a \"thumbs up\" or \"thumbs down\" button, to indicate whether or not they liked the message, or a \"snooze\" button indicating that it was not a good time to receive the message. Some features in ADAPTS are designed for AYAs and their caregivers to use together, such as a medication calendar that syncs with the eCAP and can be viewed by both members of the dyad. Following the 28-day intervention period, eCAPS will be returned and downloaded during the clinic appointment. AYAs and caregivers will complete a brief acceptability survey electronically via REDCAP, rating ADAPTS on a 5-point Likert scale to assess satisfaction, perceived appropriateness, perceive positive effects, perceived demands, and potential for future use. Exit interviews will also be conducted, audio-recorded, and transcribed to further assess acceptability. For feasibility, the following variables will be tracked: (1) screening rates, (2) recruitment rates, (3) % acknowledged micro-randomized messages, (4) technical difficulties (e.g., micro-randomized messages received when intended), (5) retention rates, and (6) completed assessments (EMA, eCAPS, post-measures).",[43,49],{"label":44,"type":45,"description":46,"interventionNames":47},"Contextually-tailored Mobile Messages for Adherence","EXPERIMENTAL","AYA participants will be micro-randomized to receive contextually-tailored mobile messages designed to promote their oral chemotherapy adherence, with a 60% probability of receiving a contextually-tailored message each day.",[48],"Behavioral: ADAPTS (ADherence Assessments and Personalized Timely Support).",{"label":50,"type":51,"description":52,"interventionNames":30},"No messages","NO_INTERVENTION","All participants will also be micro-randomized to not receive messages on some days of the intervention (\\~40% of the time).",[54],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":30},"BEHAVIORAL","ADAPTS (ADherence Assessments and Personalized Timely Support).","ADAPTS is a mobile app intervention that integrates contextually-tailored mobile messages and decision rules about when to deliver the messages, with the ultimate goal of improving oral chemotherapy adherence in AYAs with acute lymphoblastic leukemia and lymphoma. AYA participants will be micro-randomized to receive messages on some days that are adapted to their current characteristics (e.g., mood, pain, location) and designed to promote adherence, and no messages (no intervention) on other days. Other features in the app include a medication calendar that syncs with the electronic medication monitor (eCAP) to track daily adherence. A caregiver version of ADAPTS is also available, providing daily surveys (but no randomized mobile messages) and the medication calendar so that dyads can mutually track adherence.",[44],[60],{"name":61,"affiliation":5,"role":62},"Alexandra M Psihogios, Ph.D.","PRINCIPAL_INVESTIGATOR",[64],{"name":61,"role":65,"phone":66,"phoneExt":30,"email":67},"CONTACT","312-503-3577","alex.psihogios@northwestern.edu",[69],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Robert H. Lurie Comprehensive Cancer Center, Northwestern University","RECRUITING","Chicago","Illinois","60611","United States","US",{"type":78,"coordinates":79},"Point",[80,81],-87.65005,41.85003,{"lat":81,"lon":80},[84],{"name":85,"role":65,"phone":66,"phoneExt":30,"email":67},"Alexandra Psihogios, Ph.D.",{"type":62,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Alex Psihogios","Assistant Professor","100357351","mobile-health-intervention-to-support-oral-chemotherapy-adherence-in-adolescents-and-young-adults-with-leukemia-100357351",false,"NCT03932903","Mobile Health Intervention to Support Oral Chemotherapy Adherence in Adolescents and Young Adults With Leukemia","Using Real Time Mobile Health Approaches to Understand and Promote Oral Chemotherapy Adherence in Adolescents and Young Adults With Leukemia","AYA Inclusion Criteria:\n\n* Ages 14-29\n* Diagnosed with acute lymphoblastic leukemia (ALL) or lymphoma\n* In the maintenance phase, completed at least one cycle and has at least one month of maintenance therapy remaining.\n* Prescribed 6-mercaptopurine (6MP)\n* English language proficiency\n* For AYA \\<18, must have informed consent from their caregiver.\n\nAYA Exclusion Criteria:\n\n* Cognitive impairments that would limit ability to complete measures, determined by the medical team\n* Absence of inclusion criteria above.\n\nCaregiver Inclusion Criteria:\n\n* Nominated by the AYA as a primary caregiver involved in cancer care (can be a parent, relative, partner, friend)\n* English language proficiency\n\nCaregiver Exclusion Criteria:\n\n\\- Absence of inclusion criteria above.","ALL","14 Years",{"count":99,"type":100},60,"ESTIMATED","INTERVENTIONAL",[103],"NA","This is a small-scale micro-randomized clinical trial of a new mobile just-in-time adaptive intervention (JITAI) designed to promote oral chemotherapy adherence in adolescents and young adults (AYA) with acute lymphoblastic leukemia (ALL). The goals of this study are to determine intervention feasibility and acceptability.",[106,107],"Acute Lymphoblastic Leukemia","Lymphoblastic Lymphoma",[109,110,111,112,113],"Adherence","Adolescent","Young Adult","Mobile Health","Oncology","2026-06-29",{"date":116,"type":117},"2026-06-30","ACTUAL",{"date":119,"type":117},"2025-07-31",{"date":121,"type":100},"2027-08-31",{"name":5,"class":6},1]