Mosaic Trial for Stem Cell Transplant Recipients

NCT ID: NCT06960993

Last Updated: 2025-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

356 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-28

Study Completion Date

2030-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Intervention website

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Enhanced Usual Care (Control) Website

Intervention Type 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.

Interventions

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Intervention 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.

Intervention Type BEHAVIORAL

Enhanced 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Georgetown University

OTHER

Sponsor Role collaborator

Hackensack Meridian Health

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Christine Rini, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Georgetown University School of Medicine

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Site Status RECRUITING

Hackensack Meridian Health

Nutley, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Christine Rini, PhD

Role: CONTACT

312-503-7715

Sonia Zavala

Role: CONTACT

312-503-8134

Facility Contacts

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Kristi Graves, PhD

Role: primary

202-687-1591

Christine Rini, PhD

Role: primary

312-503-7715

Sonia Zavala

Role: backup

312-503-8134

Heather Derry-Vick, PhD

Role: primary

201-880-3100

Other Identifiers

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R01CA292116

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU00221336

Identifier Type: -

Identifier Source: org_study_id

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