Mosaic Trial for Stem Cell Transplant Recipients

Northwestern University

Status: Enrolling

Conditions: Hematologic Malignancy; Bone Marrow Transplant; Multiple Myeloma; Stem Cell Transplant; Lymphoma; Leukemia; Myelodysplastic Syndromes

Treatments: Behavioral: Intervention website; Behavioral: Enhanced Usual Care (Control) Website

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06960993

STU00221336

R01CA292116 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 356 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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356 participants in 2 patient groups

Intervention Website

Experimental group

Description:

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.

Treatment:

Behavioral: Intervention website

Enhanced Usual Care (Control) website

Active Comparator group

Description:

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.

Treatment:

Behavioral: Enhanced Usual Care (Control) Website