[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06960993":3,"trial-entities:NCT06960993":148,"trial-summary:NCT06960993":153},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":26,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":46,"secondary_outcomes":51,"sex":76,"minimum_age":77,"maximum_age":17,"healthy_volunteers":78,"eligibility_criteria":79,"std_ages":92,"locations":95,"central_contacts":141,"overall_officials":145,"references":146,"see_also_links":147},"NCT06960993","STU00221336","Mosaic Trial for Stem Cell Transplant Recipients","Mosaic: RCT of a Digital Health Intervention for English- and Spanish-speaking Stem Cell Transplant Recipients","RECRUITING","2030-02-01","2026-07","2026-08-03","2025-04-28","Northwestern University","OTHER",true,"The goal of this clinical trial is to learn if using an intervention website (Mosaic) improves selected patient-reported outcomes in adult blood cancer patients undergoing allogeneic or autologous stem cell transplant, compared to using an educational website (control group). Patients will be recruited prior to their scheduled transplant, then randomized to use one of these two study websites throughout the study. They will complete five assessments during the study: one before transplant (baseline) and four after transplant (2, 4, 6, and 8 month follow-ups).\n\nThe main questions this trial aims to answer are:\n\n1. Compared to patients using the control group website, do patients using the intervention website report greater improvements in general psychological distress, cancer treatment-related distress, physical symptoms, and health-related quality of life?\n2. Are these benefits at least partially explained by improvements in perceived preparedness, self-efficacy, and approach coping and\u002For reductions in avoidant coping and perceived stress?\n3. Do some patients benefit more from using the intervention website than others? Specifically, we will examine whether patients' primary language (English\u002FSpanish) and their initial psychological distress are related to the benefit they get from using the intervention website. We will also explore effects of sex, race, ethnicity, and transplant type.",null,[19,20,21,22,23,24,25],"Hematologic Malignancy","Stem Cell Transplant","Bone Marrow Transplant","Leukemia","Lymphoma","Multiple Myeloma","Myelodysplastic Syndromes",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[30],"NA",{"count":32,"type":33},356,"ESTIMATED",[35,41],{"type":36,"name":37,"description":38,"armGroupLabels":39},"BEHAVIORAL","Intervention website","Website that includes experiential information, stress and coping resources, educational content, and links to trusted websites with additional educational content and links to psychosocial resources for transplant recipients and caregivers.",[40],"Intervention Website",{"type":36,"name":42,"description":43,"armGroupLabels":44},"Enhanced Usual Care (Control) Website","Website that includes stress and coping resources, educational content, and links to trusted websites with additional educational content and links to psychosocial resources for transplant recipients and caregivers.",[45],"Enhanced Usual Care (Control) website",[47],{"measure":48,"description":49,"timeFrame":50},"Improvement in general psychological distress","Improvement in general psychological measured with the PROMIS-57 Profile v2.1 emotional distress composite score. Raw scores are calculated and converted to T scores ranging from 0 to 100, with higher scores indicating more severe distress.","Baseline to 2 months post-transplant",[52,54,56,58,61,62,63,64,67,68,69,70,73,74,75],{"measure":48,"description":49,"timeFrame":53},"Baseline to 4 months post-transplant",{"measure":48,"description":49,"timeFrame":55},"Baseline to 6 months post-transplant",{"measure":48,"description":49,"timeFrame":57},"Baseline to 8 months post-transplant",{"measure":59,"description":60,"timeFrame":50},"Improvement in cancer treatment-related distress","Improvement in cancer treatment-related distress measured with the 23-item CTXD measure. The total score is calculated as the mean response across the items, yielding a score ranging from 0 to 3. Higher scores indicate greater distress.",{"measure":59,"description":60,"timeFrame":53},{"measure":59,"description":60,"timeFrame":55},{"measure":59,"description":60,"timeFrame":57},{"measure":65,"description":66,"timeFrame":50},"Improvement in symptoms","Improvement in symptoms measured with the MDASI-Core. The measure's 13 core symptom items assess the severity of symptoms on a 0-10 numerical rating scale from 0 (not present) to 10 (as bad as you can imagine). These ratings are averaged into symptom severity score ranging from 0 to 10, with higher scores indicating more severe symptoms.",{"measure":65,"description":66,"timeFrame":53},{"measure":65,"description":66,"timeFrame":55},{"measure":65,"description":66,"timeFrame":57},{"measure":71,"description":72,"timeFrame":50},"Improvement in health-related quality of life","Improvement in health-related quality of life measured with the PROMIS Global-10 scale V1.2. Final scores are created by summing responses to each of the 10 items, then converting the raw score into two summary T-scores, each ranging from 0-100: one for Global Physical Health and one for Global Mental Health. Higher scores indicate better quality of life in the given domain.",{"measure":71,"description":72,"timeFrame":53},{"measure":71,"description":72,"timeFrame":55},{"measure":71,"description":72,"timeFrame":57},"ALL","18 Years",false,{"inclusion":80,"exclusion":87,"raw_text":91},[81,82,83,84,85,86],"Diagnosed with a hematologic cancer according to medical records","Scheduled for or preparing for scheduling of an allogeneic or autologous stem cell transplant at one of our study sites","Aged 18 or older (no upper limit)","English or Spanish Proficient","Interested in using a website to learn about stem cell transplant","Ability to understand and willingness to sign an informed consent document and comply with all study procedures",[88,89,90],"Currently participating in a behavioral intervention targeting distress, health-related quality of life, or symptoms","Undergoing the first in a planned tandem stem cell transplant","Unable to provide meaningful consent (severe cognitive impairment or language difficulties)","Inclusion Criteria:\n\n* Diagnosed with a hematologic cancer according to medical records\n* Scheduled for or preparing for scheduling of an allogeneic or autologous stem cell transplant at one of our study sites\n* Aged 18 or older (no upper limit)\n* English or Spanish Proficient\n* Interested in using a website to learn about stem cell transplant\n* Ability to understand and willingness to sign an informed consent document and comply with all study procedures\n\nExclusion Criteria:\n\n* Currently participating in a behavioral intervention targeting distress, health-related quality of life, or symptoms\n* Undergoing the first in a planned tandem stem cell transplant\n* Unable to provide meaningful consent (severe cognitive impairment or language difficulties)",[93,94],"ADULT","OLDER_ADULT",[96,111,128],{"facility":97,"status":8,"city":98,"state":99,"zip":100,"country":101,"contacts":102,"geoPoint":108},"Georgetown University School of Medicine","Washington D.C.","District of Columbia","20057","United States",[103],{"name":104,"role":105,"phone":106,"email":107},"Kristi Graves, PhD","CONTACT","202-687-1591","kristi.graves@georgetown.edu",{"lat":109,"lon":110},38.89511,-77.03637,{"facility":112,"status":8,"city":113,"state":114,"zip":115,"country":101,"contacts":116,"geoPoint":125},"Northwestern University Feinberg School of Medicine","Chicago","Illinois","60611",[117,121],{"name":118,"role":105,"phone":119,"email":120},"Alexandra Psihogios, PhD","312-503-3577","alex.psihogios@northwestern.edu",{"name":122,"role":105,"phone":123,"email":124},"Sonia Zavala","312-503-8134","sonia.zavala@northwestern.edu",{"lat":126,"lon":127},41.85003,-87.65005,{"facility":129,"status":8,"city":130,"state":131,"zip":132,"country":101,"contacts":133,"geoPoint":138},"Hackensack Meridian Health","Nutley","New Jersey","07110",[134],{"name":135,"role":105,"phone":136,"email":137},"Heather Derry-Vick, PhD","201-880-3100","heather.derryvick@hmh-cdi.org",{"lat":139,"lon":140},40.82232,-74.15987,[142,144],{"name":118,"role":105,"phone":119,"email":143},"Alex.psihogios@northwestern.edu",{"name":122,"role":105,"phone":123,"email":124},[],[],[],{"nct_id":4,"conditions":149,"biomarkers":152},[150,22,23,24,151],"Hematologic Neoplasm","Myelodysplastic Syndrome",[],{"nct_id":4,"found":15,"summary":154,"prompt_version":163},{"design":155,"status":156,"heading":6,"summary":157,"follow_up":158,"word_count":159,"commitments":160,"compensation":161,"drugs_mentioned":162},"This is an interventional study where participants will be randomly assigned to use one of two study websites. It aims to enroll 356 participants.","completed","This study, called the Mosaic Trial, is looking at whether a special website (Mosaic) can help adult blood cancer patients who are having a stem cell transplant. You would be compared to a group using a different educational website. The goal is to see if the Mosaic website improves how you feel emotionally and psychologically after your transplant. To join, you need to be at least 18 years old, have a blood cancer, be scheduled for a stem cell transplant, and be able to use a website in English or Spanish. The study will measure improvements in general psychological distress from before your transplant to two months afterward. The study plans to enroll 356 people.","You will be followed for 8 months after your transplant, with assessments at 2, 4, 6, and 8 months.",115,"You would use one of two study websites and complete five assessments: one before your transplant and four after (at 2, 4, 6, and 8 months).","Not stated in the trial record.",[],"v2"]