Clinical trial NCT06960993: Mosaic Trial for Stem Cell Transplant Recipients
Official title: Mosaic: RCT of a Digital Health Intervention for English- and Spanish-speaking Stem Cell Transplant Recipients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematologic Malignancy
Stem Cell Transplant
Bone Marrow Transplant
Leukemia
Lymphoma
Multiple Myeloma
Myelodysplastic Syndromes
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Georgetown University
name: Hackensack Meridian Health
name: National Cancer Institute (NCI)
First posted: 2025-05-07
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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)

Primary outcomes:
measure: Improvement in general psychological distress
timeFrame: Baseline to 2 months post-transplant
Secondary outcomes:
measure: Improvement in general psychological distress
timeFrame: Baseline to 4 months post-transplant
measure: Improvement in general psychological distress
timeFrame: Baseline to 6 months post-transplant
measure: Improvement in general psychological distress
timeFrame: Baseline to 8 months post-transplant
measure: Improvement in cancer treatment-related distress
timeFrame: Baseline to 2 months post-transplant
measure: Improvement in cancer treatment-related distress
timeFrame: Baseline to 4 months post-transplant
measure: Improvement in cancer treatment-related distress
timeFrame: Baseline to 6 months post-transplant
measure: Improvement in cancer treatment-related distress
timeFrame: Baseline to 8 months post-transplant
measure: Improvement in symptoms
timeFrame: Baseline to 2 months post-transplant
measure: Improvement in symptoms
timeFrame: Baseline to 4 months post-transplant
measure: Improvement in symptoms
timeFrame: Baseline to 6 months post-transplant
measure: Improvement in symptoms
timeFrame: Baseline to 8 months post-transplant
measure: Improvement in health-related quality of life
timeFrame: Baseline to 2 months post-transplant
measure: Improvement in health-related quality of life
timeFrame: Baseline to 4 months post-transplant
measure: Improvement in health-related quality of life
timeFrame: Baseline to 6 months post-transplant
measure: Improvement in health-related quality of life
timeFrame: Baseline to 8 months post-transplant
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University School of Medicine
state: District of Columbia
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Nutley
country: United States
facility: Hackensack Meridian Health
state: New Jersey
Study officials:
References: