Mosaic Trial for Stem Cell Transplant Recipients

Not Applicable

Recruiting

• Conditions: Hematologic Malignancy; Stem Cell Transplant; Bone Marrow Transplant; Multiple Myeloma; Myelodysplastic Syndromes; Leukemia; Lymphoma

• Registration Number: NCT06960993
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-28
• Study First Submitted: 2025-04-29
• Study First Submitted QC: 2025-04-29
• Status Verified: 2025-05
• Study First Posted: 2025-05-07
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-11
• Primary Completion: 2028-06-12
• Study Completion: 2030-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 356

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improvement in general psychological distress	Baseline to 2 months post-transplant	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.

Secondary Outcome Measures

Name	Time	Method
Improvement in general psychological distress	Baseline to 8 months post-transplant	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.
Improvement in cancer treatment-related distress	Baseline to 8 months post-transplant	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.
Improvement in symptoms	Baseline to 8 months post-transplant	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.
Improvement in health-related quality of life	Baseline to 8 months post-transplant	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.

Trial Locations

Locations (3)

Georgetown University School of Medicine; 🇺🇸 Washington, District of Columbia, United States

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States

Hackensack Meridian Health; 🇺🇸 Nutley, New Jersey, United States