[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Pack Health\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":110},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,85],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"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":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27],"Multiple Myeloma","Relapsed Hematologic Malignancy",[29,30,31],"Digital health","Patient reported outcomes","Wearable Activity Trackers","RECRUITING","2025-04-16",{"date":35,"type":36},"2025-04-20","ACTUAL",{"date":38,"type":36},"2023-09-15",{"date":40,"type":20},"2026-08-31",{"name":42,"class":43},"Pack Health","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":70,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},"100466092","comprehensive-outcomes-for-after-cancer-health-100466092","NCT05349227","Comprehensive Outcomes for After Cancer Health","Comprehensive Outcomes for After Cancer Health (COACH): the Feasibility and Impact of an MHealth Augmented Coaching Program for Self-Management in Cancer Survivors","COACH","Inclusion Criteria:\n\n1. Have primary diagnosis of cancer;\n2. Are within 1 year of completion of primary therapy OR have a diagnosis of metastatic cancer\n\n   1. For the purpose of this study, primary therapy is defined as treatment of curative intent, first-line or later, from which the individual is advancing to active surveillance or follow-up with or without maintenance therapy\n   2. For individuals with metastatic cancer, individuals may be included provided they completed primary therapy for a de novo diagnosis of metastatic disease within the last year, are within one year of completion of initial therapy for their primary cancer diagnosis for which disease progression has occurred, or who are within one year of receiving treatment for metastatic disease (including individuals currently receiving treatment).\n3. Are aged 18 years and older;\n4. Can read and consent to participate in the trial;\n5. Can read and speak English;\n6. Can complete study follow-up at pre-specified intervals;\n7. Have access to mobile technology (e.g. a smart phone or tablet) that would allow engagement in digital health coaching for the collection of PROs and wearable data.\n\nExclusion Criteria:\n\n1. Have a cognitive impairment (as assessed by their provider) that would prohibit the individual from engaging with the digital health coaching program or complete study assessments;\n2. Have a neurologic, musculoskeletal, or other comorbid condition that would impede their ability to engage in physical activity (as assessed by their provider)\n3. Have a life expectancy of \\<6 months, and\u002For\n4. Are on active treatment for relapsed disease. a. Individuals with disease progression or relapse which occurs following their consent to participate will be given the option to continue on study if they wish to do so. Data from individuals experiencing disease progression or relapse will be grouped for sub-analysis to explore if and how relapse impacts study outcomes.\n\nHealthy Volunteers must:\n\n1. Be adults aged 18 years or older or the age of majority in their state of residence, whichever is older.\n2. Must reside in the same dwelling as the patient participant\n3. Can read and consent to participate in the trial;\n4. Can read and speak English;\n5. Can complete study follow-up at pre-specified intervals;",true,{"count":55,"type":20},625,[23],"This study intends to explore feasibility, acceptability, and outcomes related to the use of a digital health coaching intervention for individuals who have completed primary therapy for cancer. Up to 625 individuals with diverse cancer diagnoses will be enrolled across up to 8 clinical sites to participate in a randomized wait-list control study. Those in the intervention group will receive 6 months of digital coaching up front followed by 6 months of ongoing monitoring via patient reported and clinical outcomes, as well as wearable data. Those in the control group will be monitored via patient reported and clinical outcomes as well as wearable data for the first 6 months followed by 6 months of digital health coaching. Both groups will collect fecal microbiome samples at enrollment and month 6. The study aims to explore if and how digital health coaching may be used to enhance outcomes for individuals following completion of primary cancer therapy.",[59,60,61,62,63,64,65,66,67,68,69],"Ovarian Cancer","Breast Cancer","Lung Cancer","Gastric Cancer","Survivorship","Endometrial Cancer","Head and Neck Cancers","Prostate Cancers","Geriatric Oncology","Metastatic Breast Cancer","Metastatic Cancer",[71,72,73,74,75],"Patient Reported Outcome Measures","Physical Activity","Digital Coaching","Microbiome","Wearables","2024-12-06",{"date":78,"type":36},"2024-12-11",{"date":80,"type":36},"2022-06-23",{"date":82,"type":20},"2027-05",{"name":42,"class":43},7,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},"100443377","real-world-insights-during-treatment-for-relapsedrefractory-multiple-myeloma-with-isatuximab-100443377","NCT05053607","Real World Insights During Treatment for Relapsed\u002FRefractory Multiple Myeloma with Isatuximab","Clinical and Patient Reported Outcomes for Individuals with Relapsed\u002FRefractory Multiple Myeloma Treated with Isatuximab: Real-World Insights from Patient Reported, Wearable, and Qualitative Data in the Context of Digital Health Coaching","Inclusion Criteria:\n\n* Age 18 or older\n* Diagnosis of relapsed\u002Frefractory multiple myeloma corresponding to the Food and Drug Administration (FDA) package insert for isatuximab-irfc (Sarclisa®).\n* Confirmed or planned treatment with intravenous isatuximab-irfc for relapsed\u002Frefractory multiple myeloma as standard-of-care therapy. Concurrent therapy with other agents (e.g., pomalidomide) is allowed.\n* Access to and willingness to use a smartphone or other device through which they can send and receive text messages, emails and\u002For access a mobile application.\n* Willingness to wear and have data collected by a Fitbit\n* Ability to engage in physical activity as evidenced by an Eastern Cooperative Oncology Group (ECOG) performance status score of less than or equal to 2\n\nExclusion Criteria:\n\n* 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)\n* Individuals for whom there is documentation of inability to provide consent in the medical record.\n* Individuals receiving isatuximab-irfc subcutaneously",{"count":93,"type":20},50,[23],"This descriptive study aims to evaluate the experience of adults with relapsed or refractory multiple myeloma receiving standard of care isatuximab-irfc through collection of quantitative, qualitative and wearable data. Fifty adults with relapsed or refractory multiple myeloma receiving standard of care isatuximab-irfc will be enrolled across 2 sites, The University of California San Francisco and The University of Texas MD Anderson Cancer Center. Consented participants will be enrolled in a 3-month digital health coaching program through which electronic patient reported outcomes and wearable activity data will be collected. Outcomes include treatment experience, quality of life, financial toxicity, treatment adherence, symptom burden and health self-efficacy. These will be captured by patient reported outcome measures including the Patient's Qualitative Assessment of Treatment- Real World (PQAT-RW), Patient Global Impression of Change\u002FSeverity (PGIC\u002FS), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30), Quality of Life Questionnaire Multiple Myeloma (QLQ-MY20), and the European QoL-5 Dimensions (EQ5D), Cancer Behavior Inventory-Brief Form (CBI-B), Center for Adherence Support Evaluation (CASE) Medication Adherence Index, Comprehensive Score for Financial Toxicity (COST) Instrument.\n\nClinical data, including treatment history, healthcare utilization, and co-morbidities, as well as demographic data will be collected via the electronic health record from each clinical site. This data will be complemented by qualitative data from a selected cohort of study participants with a focus on treatment experience ranging from infusion burden, toxicity management, to overall quality of life. Evaluation of this data in combination will be used to better understand the treatment experience of individuals on standard of care isatuximab-irfc specifically, and with relapsed or refractory multiple myeloma generally, contributing to an existing gap in the literature regarding patient reported outcomes from diverse data sources. Outcomes will be analyzed with attention to the relationship between social determinants of health, including race, ethnicity, and geographic location, and treatment experience as reflected in both the qualitative and quantitative data.",[26,97],"Refractory Multiple Myeloma",[99,100,101,102],"isatuximab","wearable electronic devices","qualitative research","patient reported outcome measures",{"date":78,"type":36},{"date":105,"type":36},"2022-06-17",{"date":107,"type":20},"2025-12-31",{"name":42,"class":43},2,""]