Mosaic: RCT of a Digital Health Intervention for English- and Spanish-speaking Stem Cell Transplant Recipients
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.
Arms & 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.
Outcome measures
Primary
Improvement in general psychological distress
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.
Time frame: Baseline to 2 months post-transplant
Secondary
Improvement in general psychological distress
Time frame: Baseline to 4 months post-transplant
Improvement in general psychological distress
Time frame: Baseline to 6 months post-transplant
Improvement in general psychological distress
Time frame: Baseline to 8 months post-transplant
Improvement in cancer treatment-related distress
Time frame: Baseline to 2 months post-transplant
Improvement in cancer treatment-related distress
Time frame: Baseline to 4 months post-transplant
Improvement in cancer treatment-related distress
Time frame: Baseline to 6 months post-transplant
Improvement in cancer treatment-related distress
Time frame: Baseline to 8 months post-transplant
Improvement in symptoms
Time frame: Baseline to 2 months post-transplant
Improvement in symptoms
Time frame: Baseline to 4 months post-transplant
Improvement in symptoms
Time frame: Baseline to 6 months post-transplant
Improvement in symptoms
Time frame: Baseline to 8 months post-transplant
Improvement in health-related quality of life
Time frame: Baseline to 2 months post-transplant
Improvement in health-related quality of life
Time frame: Baseline to 4 months post-transplant
Improvement in health-related quality of life
Time frame: Baseline to 6 months post-transplant
Improvement in health-related quality of life
Time frame: Baseline to 8 months post-transplant
Eligibility criteria
Study locations (3)
Georgetown University School of Medicine
Washington D.C., District of Columbia, 20057
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Hackensack Meridian Health
Nutley, New Jersey, 07110