Mosaic Trial for Stem Cell Transplant Recipients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intervention website, Enhanced Usual Care (Control) Website.
- Who it may be relevant to
- Registry conditions: Hematologic Malignancy, Stem Cell Transplant, Bone Marrow Transplant, Leukemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Mosaic: RCT of a Digital Health Intervention for English- and Spanish-speaking Stem Cell Transplant Recipients
Overview
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.
Interventions
- 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. - Behavioral 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.
Primary outcome measures
- Improvement in general psychological distress [Time frame: Baseline to 2 months post-transplant]
Secondary outcome measures (12)
- Improvement in general psychological distress [Time frame: Baseline to 4 months post-transplant]
- Improvement in general psychological distress [Time frame: Baseline to 6 months post-transplant]
- Improvement in general psychological distress [Time frame: Baseline to 8 months post-transplant]
- Improvement in cancer treatment-related distress [Time frame: Baseline to 2 months post-transplant]
- Improvement in cancer treatment-related distress [Time frame: Baseline to 4 months post-transplant]
- Improvement in cancer treatment-related distress [Time frame: Baseline to 6 months post-transplant]
- Improvement in cancer treatment-related distress [Time frame: Baseline to 8 months post-transplant]
- Improvement in symptoms [Time frame: Baseline to 2 months post-transplant]
- Improvement in symptoms [Time frame: Baseline to 4 months post-transplant]
- Improvement in symptoms [Time frame: Baseline to 6 months post-transplant]
- Improvement in symptoms [Time frame: Baseline to 8 months post-transplant]
- Improvement in health-related quality of life [Time frame: Baseline to 2 months post-transplant]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 3 centers
- Georgetown University School of Medicine — Washington D.C.
- Northwestern University Feinberg School of Medicine — Chicago
- Hackensack Meridian Health — Nutley
Identifiers
NCT: NCT06960993 · STU00221336 · R01CA292116