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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Washington, D.c.
Georgetown University School of Medicine
RECRUITING
Washington D.c.
Illinois
Northwestern University Feinberg School of Medicine
RECRUITING
Chicago
New Jersey
Hackensack Meridian Health
RECRUITING
Nutley
Contact Information
Primary
Christine Rini, PhD
christine.rini@northwestern.edu
312-503-7715
Backup
Sonia Zavala
sonia.zavala@northwestern.edu
312-503-8134
Time Frame
Start Date: 2025-04-28
Estimated Completion Date: 2030-02-01
Participants
Target number of participants: 356
Treatments
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.
Sponsors
Collaborators: Hackensack Meridian Health, Georgetown University, National Cancer Institute (NCI)
Leads: Northwestern University

This content was sourced from clinicaltrials.gov