Mosaic Trial for Stem Cell Transplant Recipients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

356 Participants
are divided into 2 treatment groups
Group A: Intervention WebsiteExperimental treatment 1 intervention
Group B: Enhanced Usual Care (Control) websiteActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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 outcomes

1

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 4 months post-transplant
2

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 6 months post-transplant
3

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 8 months post-transplant
4

Improvement in cancer treatment-related distress

Improvement in cancer treatment-related distress measured with the 23-item CTXD measure. The total score is calculated as the mean response across the items, yielding a score ranging from 0 to 3. Higher scores indicate greater distress.

Time frame
Baseline to 2 months post-transplant

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

Georgetown University

Collaborator

Hackensack Meridian Health

Collaborator

National Cancer Institute (NCI)

Collaborator