Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-01 @ 11:55 PM
Study NCT ID:
NCT06960993
Status:
RECRUITING
Last Update Posted:
2025-07-18
First Post:
2025-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mosaic Trial for Stem Cell Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 356}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2030-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2025-04-29', 'studyFirstSubmitQcDate': '2025-04-29', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in general psychological distress', 'timeFrame': 'Baseline to 2 months post-transplant', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Improvement in general psychological distress', 'timeFrame': 'Baseline to 4 months post-transplant', 'description': '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.'}, {'measure': 'Improvement in general psychological distress', 'timeFrame': 'Baseline to 6 months post-transplant', 'description': '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.'}, {'measure': 'Improvement in general psychological distress', 'timeFrame': 'Baseline to 8 months post-transplant', 'description': '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.'}, {'measure': 'Improvement in cancer treatment-related distress', 'timeFrame': 'Baseline to 2 months post-transplant', 'description': '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': 'Improvement in cancer treatment-related distress', 'timeFrame': 'Baseline to 4 months post-transplant', 'description': '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': 'Improvement in cancer treatment-related distress', 'timeFrame': 'Baseline to 6 months post-transplant', 'description': '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': 'Improvement in cancer treatment-related distress', 'timeFrame': 'Baseline to 8 months post-transplant', 'description': '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': 'Improvement in symptoms', 'timeFrame': 'Baseline to 2 months post-transplant', 'description': "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': 'Improvement in symptoms', 'timeFrame': 'Baseline to 4 months post-transplant', 'description': "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': 'Improvement in symptoms', 'timeFrame': 'Baseline to 6 months post-transplant', 'description': "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': 'Improvement in symptoms', 'timeFrame': 'Baseline to 8 months post-transplant', 'description': "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': 'Improvement in health-related quality of life', 'timeFrame': 'Baseline to 2 months post-transplant', 'description': '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': 'Improvement in health-related quality of life', 'timeFrame': 'Baseline to 4 months post-transplant', 'description': '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': 'Improvement in health-related quality of life', 'timeFrame': 'Baseline to 6 months post-transplant', 'description': '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': 'Improvement in health-related quality of life', 'timeFrame': 'Baseline to 8 months post-transplant', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematologic Malignancy', 'Stem Cell Transplant', 'Bone Marrow Transplant', 'Leukemia', 'Lymphoma', 'Multiple Myeloma', 'Myelodysplastic Syndromes']}, 'descriptionModule': {'briefSummary': "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/or 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/Spanish) 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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)'}, 'identificationModule': {'nctId': 'NCT06960993', 'acronym': 'Mosaic', 'briefTitle': 'Mosaic Trial for Stem Cell Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Mosaic: RCT of a Digital Health Intervention for English- and Spanish-speaking Stem Cell Transplant Recipients', 'orgStudyIdInfo': {'id': 'STU00221336'}, 'secondaryIdInfos': [{'id': 'R01CA292116', 'link': 'https://reporter.nih.gov/quickSearch/R01CA292116', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Website', 'description': 'The intervention website pairs experiential information about transplant with (1) coordinated coping and stress management training and resources to support skill practice and (2) an educational component that includes educational content and links to well-established, vetted websites that provide broader, provider-reviewed information about the transplant process and links to psychosocial resources. Participants can toggle between English and Spanish content, and they will be able to use this website throughout their participation in the study.', 'interventionNames': ['Behavioral: Intervention website']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced Usual Care (Control) website', 'description': 'The control website pairs (1) coordinated coping and stress management training and resources to support skill practice with (2) an educational component that includes educational content and links to well-established, vetted websites that provide broader, provider-reviewed information about the transplant process and links to psychosocial resources, using the same technology platform and look/feel as the intervention website.\n\nParticipants can toggle between the English and Spanish versions of the website and they will be able to use this website throughout their participation in the study.', 'interventionNames': ['Behavioral: Enhanced Usual Care (Control) Website']}], 'interventions': [{'name': 'Intervention website', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Intervention Website']}, {'name': 'Enhanced Usual Care (Control) Website', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Enhanced Usual Care (Control) website']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20057', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kristi Graves, PhD', 'role': 'CONTACT', 'email': 'kristi.graves@georgetown.edu', 'phone': '202-687-1591'}], 'facility': 'Georgetown University School of Medicine', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christine Rini, PhD', 'role': 'CONTACT', 'email': 'christine.rini@northwestern.edu', 'phone': '312-503-7715'}, {'name': 'Sonia Zavala', 'role': 'CONTACT', 'email': 'sonia.zavala@northwestern.edu', 'phone': '312-503-8134'}], 'facility': 'Northwestern University Feinberg School of Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '07110', 'city': 'Nutley', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Heather Derry-Vick, PhD', 'role': 'CONTACT', 'email': 'heather.derryvick@hmh-cdi.org', 'phone': '201-880-3100'}], 'facility': 'Hackensack Meridian Health', 'geoPoint': {'lat': 40.82232, 'lon': -74.15987}}], 'centralContacts': [{'name': 'Christine Rini, PhD', 'role': 'CONTACT', 'email': 'christine.rini@northwestern.edu', 'phone': '312-503-7715'}, {'name': 'Sonia Zavala', 'role': 'CONTACT', 'email': 'sonia.zavala@northwestern.edu', 'phone': '312-503-8134'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We will not be sharing IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Georgetown University', 'class': 'OTHER'}, {'name': 'Hackensack Meridian Health', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Christine Rini, PhD', 'investigatorAffiliation': 'Northwestern University'}}}}