Hematologic MalignancyMosaicNCT06960993
Mosaic Trial for Stem Cell Transplant Recipients
A study testing Intervention website in people with Hematologic Malignancy and Stem Cell Transplant, run by Northwestern University at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancy, Stem Cell Transplant, Bone Marrow Transplant
- What is being tested?
- Intervention website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Apr 2025to 1 Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Alexandra Psihogios, PhD, 312-503-3577, alex.psihogios@northwestern.edu
Sonia Zavala, 312-503-8134, sonia.zavala@northwestern.edu
- Recruiting
Hackensack Meridian Health
Nutley, New Jersey, 07110
Heather Derry-Vick, PhD, 201-880-3100, heather.derryvick@hmh-cdi.org
- Recruiting
Georgetown University School of Medicine
Washington D.C., District of Columbia, 20057
Kristi Graves, PhD, 202-687-1591, kristi.graves@georgetown.edu
About this study
Official title: Mosaic: RCT of a Digital Health Intervention for English- and Spanish-speaking Stem Cell Transplant Recipients
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.
- Conditions
- Hematologic Malignancy, Stem Cell Transplant, Bone Marrow Transplant, Leukemia, Lymphoma, Multiple Myeloma
- Being tested
- Intervention website, Enhanced Usual Care (Control) Website
- Medical subject headings
- Hematologic Neoplasms, Leukemia, Lymphoma, Multiple Myeloma, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention websiteBehavioural
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) WebsiteBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Website | Experimental | 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. Receives: Behavioral: Intervention website |
| Enhanced Usual Care (Control) website | Active comparator | 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. Receives: Behavioral: Enhanced Usual Care (Control) Website |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 2 months post-transplant
Secondary outcomes (15)
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.
Measured: Baseline to 4 months post-transplant
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.
Measured: Baseline to 6 months post-transplant
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.
Measured: Baseline to 8 months post-transplant
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.
Measured: Baseline to 2 months post-transplant
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.
Measured: Baseline to 4 months post-transplant
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.
Measured: Baseline to 6 months post-transplant
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.
Measured: Baseline to 8 months post-transplant
Improvement in symptoms
Improvement in symptoms measured with the MDASI-Core. The measure's 13 core symptom items assess the severity of symptoms on a 0-10 numerical rating scale from 0 (not present) to 10 (as bad as you can imagine). These ratings are averaged into symptom severity score ranging from 0 to 10, with higher scores indicating more severe symptoms.
Measured: Baseline to 2 months post-transplant
Improvement in symptoms
Improvement in symptoms measured with the MDASI-Core. The measure's 13 core symptom items assess the severity of symptoms on a 0-10 numerical rating scale from 0 (not present) to 10 (as bad as you can imagine). These ratings are averaged into symptom severity score ranging from 0 to 10, with higher scores indicating more severe symptoms.
Measured: Baseline to 4 months post-transplant
Improvement in symptoms
Improvement in symptoms measured with the MDASI-Core. The measure's 13 core symptom items assess the severity of symptoms on a 0-10 numerical rating scale from 0 (not present) to 10 (as bad as you can imagine). These ratings are averaged into symptom severity score ranging from 0 to 10, with higher scores indicating more severe symptoms.
Measured: Baseline to 6 months post-transplant
Improvement in symptoms
Improvement in symptoms measured with the MDASI-Core. The measure's 13 core symptom items assess the severity of symptoms on a 0-10 numerical rating scale from 0 (not present) to 10 (as bad as you can imagine). These ratings are averaged into symptom severity score ranging from 0 to 10, with higher scores indicating more severe symptoms.
Measured: Baseline to 8 months post-transplant
Improvement in health-related quality of life
Improvement in health-related quality of life measured with the PROMIS Global-10 scale V1.2. Final scores are created by summing responses to each of the 10 items, then converting the raw score into two summary T-scores, each ranging from 0-100: one for Global Physical Health and one for Global Mental Health. Higher scores indicate better quality of life in the given domain.
Measured: Baseline to 2 months post-transplant
Improvement in health-related quality of life
Improvement in health-related quality of life measured with the PROMIS Global-10 scale V1.2. Final scores are created by summing responses to each of the 10 items, then converting the raw score into two summary T-scores, each ranging from 0-100: one for Global Physical Health and one for Global Mental Health. Higher scores indicate better quality of life in the given domain.
Measured: Baseline to 4 months post-transplant
Improvement in health-related quality of life
Improvement in health-related quality of life measured with the PROMIS Global-10 scale V1.2. Final scores are created by summing responses to each of the 10 items, then converting the raw score into two summary T-scores, each ranging from 0-100: one for Global Physical Health and one for Global Mental Health. Higher scores indicate better quality of life in the given domain.
Measured: Baseline to 6 months post-transplant
Improvement in health-related quality of life
Improvement in health-related quality of life measured with the PROMIS Global-10 scale V1.2. Final scores are created by summing responses to each of the 10 items, then converting the raw score into two summary T-scores, each ranging from 0-100: one for Global Physical Health and one for Global Mental Health. Higher scores indicate better quality of life in the given domain.
Measured: Baseline to 8 months post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start28 Apr 2025
- Primary completion12 Jun 2028 (estimated)
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Georgetown University, Hackensack Meridian Health, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Alex Psihogios, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960993
- Sponsor's protocol ID
- STU00221336
- Other IDs
- R01CA292116
- Acronym
- Mosaic
- Status last verified
- Jul 2026
- First submitted
- 29 Apr 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not be sharing IPD
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mosaic: RCT of a Digital Health Intervention for English- and Spanish-speaking Stem Cell Transplant Recipients
- ClinicalTrials.gov ID
- NCT06960993
- Acronym / sponsor ID
- Mosaic / STU00221336
- Conditions
- Hematologic Malignancy, Stem Cell Transplant, Bone Marrow Transplant, Leukemia, Lymphoma, Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Georgetown University, Hackensack Meridian Health, National Cancer Institute (NCI)
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 12 Jun 2028 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Website | Experimental | Behavioral: Intervention websiteThe 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. |
| Enhanced Usual Care (Control) website | Active comparator | Behavioral: Enhanced Usual Care (Control) WebsiteThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention websiteWebsite 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. | Behavioural | Intervention Website |
| Enhanced Usual Care (Control) WebsiteWebsite 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. | Behavioural | Enhanced Usual Care (Control) website |
Primary outcome
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.
15 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No. We will not be sharing IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention website in people with Hematologic Malignancy and Stem Cell Transplant, run by Northwestern University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Psihogios, PhD (312-503-3577, Alex.psihogios@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in general psychological distress (time frame: Baseline to 2 months post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.