Mosaic: RCT of a Digital Health Intervention for English- and Spanish-speaking Stem Cell Transplant Recipients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Northwestern University
- Enrollment
- 356
- Locations
- 5
- Primary Endpoint
- Improvement in general psychological distress
Study Overview
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:
- 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?
- 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?
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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.
Intervention: Intervention website (Behavioral)
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.
Intervention: Enhanced Usual Care (Control) Website (Behavioral)
Outcomes
Primary Outcomes
Improvement in general psychological distress
Time Frame: 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 Outcomes
- Improvement in general psychological distress(Baseline to 8 months post-transplant)
- Improvement in cancer treatment-related distress(Baseline to 8 months post-transplant)
- Improvement in symptoms(Baseline to 8 months post-transplant)
- Improvement in health-related quality of life(Baseline to 8 months post-transplant)
Investigators
Alex Psihogios
Assistant Professor
Northwestern University