[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658337":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":35,"studyPopulation":39,"armGroups":40,"interventions":46,"overallOfficials":54,"centralContacts":59,"locations":68,"responsibleParty":87,"collaborators":35,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":35,"eligibilityCriteria":94,"healthyVolunteers":91,"sex":95,"minAge":96,"maxAge":35,"enrollmentInfo":97,"targetDuration":35,"studyType":100,"phases":35,"briefSummary":101,"conditions":102,"keywords":35,"overallStatus":70,"whyStopped":35,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Mayo Clinic","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":35,"otherOutcomes":35},[9,13,16,19,22,25,29,32],{"measure":10,"description":11,"timeFrame":12},"Engagement (Aim 1) - daily and weekly response rates","Engagement will be evaluated by daily and weekly response rates. A response rate of ≥60% to daily prompts (e.g., ≥4 days per week) will be considered acceptable engagement.","Up to 3 months",{"measure":14,"description":15,"timeFrame":12},"Engagement (Aim 1) - uninterrupted participation","Engagement will be evaluated by the duration (number of days) of uninterrupted participation (e.g., consecutive response to daily prompts with missed days).",{"measure":17,"description":18,"timeFrame":12},"Engagement (Aim 1) - complete symptom data","Engagement will be evaluated by the proportion of days with complete symptom data entered by participants.",{"measure":20,"description":21,"timeFrame":12},"Acceptability (Aim 1) - CSQ-8","Acceptability will be measured using a post study survey: Client Satisfaction Questionnaire-8 (CSQ-8). The CSQ-8 is a self-report questionnaire used to measure general client satisfaction. It consists of 8 questions answered on a 4-point scale (e.g., quite dissatisfied, mildly dissatisfied, mostly satisfied, very satisfied). Total scores range from 8 to 32 with higher scores indicating higher satisfaction.",{"measure":23,"description":24,"timeFrame":12},"System-generated alerts (Aim 2)","Will determine the proportion of alerts that prompt documented clinical actions (e.g., triage calls, provider outreach, medication adjustments, referrals, and\u002For unplanned visits). Alerts will be considered effective if ≥30% of alerts prompt clinical actions.",{"measure":26,"description":27,"timeFrame":28},"Symptom and Quality of Life (QOL) trajectories (Aim 3) - PROMIS-29","Daily symptom and quality of life (QOL) trajectories will be modeled across treatment cycles. The Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) is used to assess patient-reported outcomes over the past 7 days across seven health domains: physical function, anxiety, depression, fatigue, sleep disturbance, social roles participation, and pain interference. Scores are scaled so that an average person would have a score of 50. Higher scores indicate more of the item being measured. Raw scores are converted to T-scores, with higher scores indicating better quality of life (QOL). Changes in PROMIS-29 scores will be evaluated using established minimal clinically important differences (MCIDs). Clinically meaningful deterioration will be defined as ≥ 2-point worsening in symptom severity, emergence of new severe symptoms, and deterioration in QOL scores in ≥20% of patients.","Baseline to 3 months",{"measure":30,"description":31,"timeFrame":28},"Symptom and QOL trajectories (Aim 3) - SF-36","Daily symptom trajectories will be modeled across treatment cycles. The 36-Item Short Form Survey (SF-36) is used to measure patient health and disability. Participants rate items on a scale of 1 (all of the time) to 6 (none of the time) or 1 (not at all) to 5 (extremely) with higher scores indicating greater quality of life. Changes in SF-36 scores will be evaluated using established MCIDs. Clinically meaningful deterioration will be defined as ≥ 2-point worsening in symptom severity, emergence of new severe symptoms, and deterioration in QOL scores in ≥20% of patients.",{"measure":33,"description":34,"timeFrame":28},"Change in Frailty status (Aim 4) - IMWG-FI","Frailty will be assessed using the International Myeloma Working Group-Frailty Index (IMWG-FI). The IMWG-FI will be analyzed as a continuous and categorical variable; patients will be classified into 3 categories (fit, intermediate fit, or frail). Total scores range from 0-5, with a score of 0 indicating fit, a score of 1 indicating intermediate fitness, and a score of ≥2 indicating frailty.",null,{"allocation":35,"interventionModel":35,"interventionModelDescription":35,"primaryPurpose":35,"observationalModel":37,"timePerspective":38,"maskingInfo":35},"COHORT","PROSPECTIVE","Patients age ≥ 18 years who have a diagnosis of MM and\u002For AL amyloidosis and are planned to start treatment at Mayo Clinic or another treatment facility",[41],{"label":42,"type":35,"description":43,"interventionNames":44},"Observational","Patients are enrolled in the Quality of life text message system and receive SMS text messages and complete questionnaires daily for 3 months on study.",[45],"Other: Non-Interventional Study",[47],{"type":6,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"Non-Interventional Study","Non-interventional study",[42],[52,53],"Non-Interventional Observational Study","Noninterventional (Observational) Study",[55],{"name":56,"affiliation":57,"role":58},"Nadine H. Abdallah, MD","Mayo Clinic in Rochester","PRINCIPAL_INVESTIGATOR",[60,65],{"name":61,"role":62,"phone":63,"phoneExt":35,"email":64},"Clinical Trials Referral Office","CONTACT","855-776-0015","mayocliniccancerstudies@mayo.edu",{"name":66,"role":62,"phone":67,"phoneExt":35,"email":35},"Sarah Aug","507-538-1307",[69],{"facility":57,"status":70,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"RECRUITING","Rochester","Minnesota","55905","United States","US",{"type":77,"coordinates":78},"Point",[79,80],-92.4699,44.02163,{"lat":80,"lon":79},[83,85],{"name":66,"role":62,"phone":84,"phoneExt":35,"email":35},"507-538-1301",{"name":86,"role":58,"phone":35,"phoneExt":35,"email":35},"Nadine Abdallah, MD",{"type":88,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100658337","sms-based-remote-symptom-monitoring-for-patients-with-plasma-cell-disorders-100658337",false,"NCT07850284","SMS-Based Remote Symptom Monitoring for Patients With Plasma Cell Disorders","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Diagnosis of MM or AL based on IMWG diagnostic criteria\n* Planned to start a new treatment within 14 days (+\u002F-7 days)\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Not able to give informed consent","ALL","18 Years",{"count":98,"type":99},150,"ESTIMATED","OBSERVATIONAL","This study evaluates whether daily SMS-based (text messages) symptom monitoring is feasible and acceptable in patients who are undergoing treatment for multiple myeloma (MM) or systemic light chain amyloidosis (AL), and whether it can help in early identification of symptoms that may require clinical attention.",[103,104],"AL Amyloidosis","Multiple Myeloma","2026-09-24",{"date":107,"type":108},"2026-09-30","ACTUAL",{"date":110,"type":108},"2026-08-25",{"date":112,"type":99},"2028-08-25",{"name":5,"class":6},1]