RecruitingNot ApplicableNCT06960993

Mosaic Trial for Stem Cell Transplant Recipients

Mosaic: RCT of a Digital Health Intervention for English- and Spanish-speaking Stem Cell Transplant Recipients


Sponsor

Northwestern University

Enrollment

356 participants

Start Date

Apr 28, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria3

  • 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)

Interventions

BEHAVIORALIntervention 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.

BEHAVIORALEnhanced 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.


Locations(3)

Georgetown University School of Medicine

Washington D.C., District of Columbia, United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Hackensack Meridian Health

Nutley, New Jersey, United States

View Full Details on ClinicalTrials.gov

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NCT06960993


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