Mosaic Trial for Stem Cell Transplant Recipients

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Northwestern University
Study ID
NCT06960993
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intervention website — BEHAVIORAL
    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.
  • Enhanced Usual Care (Control) Website — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Apr 28, 2025
Status verified
Jul 2025
Primary completion
Jun 12, 2028
Completion
Feb 1, 2030

Study Design

Enrollment
356 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Intervention Website
    The 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.
  • Active Comparator: Enhanced Usual Care (Control) website
    The 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.

Primary Outcome Measure

Improvement in general psychological distress [ Time Frame: Baseline to 2 months post-transplant ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Georgetown University School of MedicineWashington D.C.District of Columbia20057
Kristi Graves, PhD
[email protected]
202-687-1591
Northwestern University Feinberg School of MedicineChicagoIllinois60611
Christine Rini, PhD
[email protected]
312-503-7715
Sonia Zavala
[email protected]
312-503-8134
Hackensack Meridian HealthNutleyNew Jersey07110
Heather Derry-Vick, PhD
[email protected]
201-880-3100

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