Mosaic Trial for Stem Cell Transplant Recipients
Mosaic
Mosaic: RCT of a Digital Health Intervention for English- and Spanish-speaking Stem Cell Transplant Recipients
2 other identifiers
interventional
356
1 country
3
Brief Summary
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). The main questions this trial aims to answer are:
- 1.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?
- 2.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?
- 3.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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2025
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 28, 2025
CompletedFirst Submitted
Initial submission to the registry
April 29, 2025
CompletedFirst Posted
Study publicly available on registry
May 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 12, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2030
July 18, 2025
July 1, 2025
3.1 years
April 29, 2025
July 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (15)
Improvement in general psychological distress
Baseline to 4 months post-transplant
Improvement in general psychological distress
Baseline to 6 months post-transplant
Improvement in general psychological distress
Baseline to 8 months post-transplant
Improvement in cancer treatment-related distress
Baseline to 2 months post-transplant
Improvement in cancer treatment-related distress
Baseline to 4 months post-transplant
- +10 more secondary outcomes
Study Arms (2)
Intervention Website
EXPERIMENTALThe 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.
Enhanced Usual Care (Control) website
ACTIVE COMPARATORThe 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. Participants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwestern Universitylead
- Georgetown Universitycollaborator
- Hackensack Meridian Healthcollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (3)
Georgetown University School of Medicine
Washington D.C., District of Columbia, 20057, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611, United States
Hackensack Meridian Health
Nutley, New Jersey, 07110, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 29, 2025
First Posted
May 7, 2025
Study Start
April 28, 2025
Primary Completion (Estimated)
June 12, 2028
Study Completion (Estimated)
February 1, 2030
Last Updated
July 18, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share
We will not be sharing IPD