[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512746":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":64,"collaborators":66,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":40,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":40,"enrollmentInfo":80,"targetDuration":40,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":46,"whyStopped":40,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Pack Health","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Arm Cohort Receiving Digital Health Coaching","EXPERIMENTAL","All study participants will be enrolled in a 3-month digital health coaching program. They will also receive a Fitbit device to be worn daily for the capture of physical activity data.",[13,14],"Behavioral: Digital Health Coaching Program","Device: Fitbit",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"BEHAVIORAL","Digital Health Coaching Program","Digital health intervention consisting of weekly calls from a Health Advisor to a participant, accompanied by delivery of evidence-based content across health and wellness domains (e.g. nutrition, exercise, physical, emotional and financial health) up to 4 times weekly via text, email or mobile application.",[9],[22],"Pack Health Digital Health Coaching",{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","Fitbit","A wrist-worn activity tracker allowing for the capture of physical activity, including but not limited to step-count and minutes of activity, to be captured daily.",[9],[29],"Charge 5",[31],{"name":32,"affiliation":33,"role":34},"Rahul Banerjee, MD","University of Washington","PRINCIPAL_INVESTIGATOR",[36,42],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Kelly Brassil, PhD","CONTACT","205-721-7542",null,"dgxpharesearch@questdiagnostics.com",{"name":43,"role":38,"phone":39,"phoneExt":40,"email":41},"Jennifer Loftis, DNP",[45],{"facility":33,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Seattle","Washington","98195","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-122.33207,47.60621,{"lat":56,"lon":55},[59,63],{"name":60,"role":38,"phone":61,"phoneExt":40,"email":62},"Trenton Grossfeld","206.606.1774","tgrossfeld@fredhutch.org",{"name":32,"role":34,"phone":40,"phoneExt":40,"email":40},{"type":65,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR",[67,69],{"name":33,"class":68},"OTHER",{"name":70,"class":6},"GlaxoSmithKline","100512746","pro-and-wearable-data-insights-from-individuals-with-rr-multiple-myeloma-100512746",false,"NCT05956457","PRO and Wearable Data Insights From Individuals With R\u002FR Multiple Myeloma","Evaluating Patient-Reported Outcomes and Wearable Data Among Individuals With Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n1. Age 18 or older\n2. Confirmed diagnosis of MM as determined by participants' primary physicians at the study site. Patients with concurrent AL amyloidosis will be eligible.\n3. Initiation of at least the second line of MM-directed therapy for multiple myeloma at time of study enrollment. Participants must have been exposed to at least one proteasome inhibitor (PI) and\u002For one immunomodulatory drug (IMiD).\n\nExclusion Criteria:\n\n1. Individuals who are terminally ill, defined as individuals identified by their physician as likely having 6 months or less to live, or those individuals transitioned to comfort measures only (meaning only supportive care measures without curative focused treatment)\n2. Individuals who have previously participated in Pack Health digital health coaching\n3. Physician-assessed lack of sufficient English proficiency\n4. Lack of ownership of a personal smartphone or device allowing for access to text, email or mobile application\n5. Any serious and\u002For unstable pre-existing medical, psychiatric, or other condition that could interfere with participant's safety, provision of informed consent, or compliance with study procedures\n6. Concurrent enrollment on a therapeutic study in R\u002FR MM that precludes simultaneous enrollment onto our non-therapeutic study","ALL","18 Years",{"count":81,"type":82},100,"ESTIMATED","INTERVENTIONAL",[85],"NA","This study will evaluate the feasibility of a digital health coaching program for adults with relapsed or refractory multiple myeloma (R\u002FR MM). One hundred adults with R\u002FR MM will be enrolled at The University of Washington. Individuals who agree to take part in the study and sign an informed consent will be enrolled in a 3-month digital health coaching program. The program will provide weekly phone calls plus the delivery of learning materials to text or email. Questionnaires and data from a wrist-worn activity tracker will be collected. Outcomes include treatment and symptom experience, quality of life, financial burden, and how confident people feel to manage their health. Information about your condition and treatment will be collected, along with how often you use services like the emergency room, for care. This data will provide a better understanding of how a person experiences their R\u002FR MM.",[88,89],"Multiple Myeloma","Relapsed Hematologic Malignancy",[91,92,93],"Digital health","Patient reported outcomes","Wearable Activity Trackers","2025-04-16",{"date":96,"type":97},"2025-04-20","ACTUAL",{"date":99,"type":97},"2023-09-15",{"date":101,"type":82},"2026-08-31",{"name":5,"class":6},1]