Mosaic Website for Blood Cancer Patients

(Mosaic Trial)

Recruiting at 2 trial locations

Overseen By Sonia Zavala

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Behavioral intervention, Tandem transplant, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

356 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on using a website to improve outcomes for blood cancer patients undergoing stem cell transplants.

What data supports the effectiveness of the treatment Mosaic for blood cancer patients?

Electronic patient-reported outcomes (ePROs) have been shown to improve the quality of life and survival in cancer patients receiving chemotherapy, suggesting that similar web-based platforms like Mosaic could enhance patient care by improving symptom management and healthcare resource use. ^{1 2 3 4 5}

How is the Mosaic treatment for blood cancer different from other treatments?

The Mosaic treatment is unique because it involves a web-based platform designed to empower blood cancer patients by providing personalized information and support, which is not typically a feature of standard treatments. This approach focuses on enhancing patient engagement and understanding of their condition, potentially improving treatment adherence and outcomes. ^{2 6 7 8 9}

What is the purpose of 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

Adult blood cancer patients scheduled for allogeneic or autologous stem cell transplant are eligible. The trial is suitable for those with conditions like myelodysplastic syndrome, multiple myeloma, leukemia, lymphoma, and other hematological malignancies.

Inclusion Criteria

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

My medical records show I have blood cancer.

Exclusion Criteria

Unable to provide meaningful consent (severe cognitive impairment or language difficulties)

I am currently in a program to help with stress, health quality, or symptoms.

I am preparing for my first stem cell transplant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-transplant Baseline Assessment

Participants complete a baseline assessment before the scheduled stem cell transplant

1 week

1 visit (in-person or virtual)

Post-transplant Follow-up

Participants complete follow-up assessments at 2, 4, 6, and 8 months post-transplant to evaluate psychological distress, symptoms, and quality of life

8 months

4 visits (virtual)

Long-term Follow-up

Participants are monitored for long-term outcomes beyond the initial 8-month follow-up period

6 months

Treatment Details

Interventions

• Mosaic

Trial Overview The Mosaic Trial compares the effects of an intervention website designed to support patients' psychological and physical well-being against a control educational website. Participants will be randomly assigned to one of these websites before their transplant.

Participant Groups

Group I: Intervention Website Experimental Treatment 1 Intervention

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 II: Enhanced Usual Care (Control) website Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Georgetown University

Collaborator

Trials

355

Recruited

142,000+

Hackensack Meridian Health

Collaborator

Trials

141

Recruited

42,900+

Findings from Research

In a study involving 79 cancer patients (30 Black and 49 White), electronic patient-reported outcomes (ePROs) were found to be valuable for symptom monitoring, with Black patients reporting greater benefits in facilitating discussions with clinicians compared to White patients.

While most participants preferred a web-based system, Black patients showed a higher preference for automated telephone options and paper-based formats, indicating the need for diverse ePRO options to accommodate varying e-health literacy levels among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Racial differences in user experiences and perceived value of electronic symptom monitoring in a cohort of black and white bladder and prostate cancer patients. Samuel, CA., Smith, AB., Elkins, W., et al.[2022]

The QuestLeukemia mobile app was found to be an effective educational tool for pediatric patients preparing for hematopoietic cell transplantation (HCT), enhancing their disease knowledge and autonomy, as reported by both patients and parents.

Participants rated the app highly for usability and enjoyment, with average scores indicating it was easy to use (4.93), enjoyable (4.79), and comprehensive (4.71), suggesting it could positively impact the HCT experience for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability and Acceptability of the QuestLeukemia Mobile Application: A Pilot Study for An Educational and Psychological Intervention for Children with Chronic Illnesses. Meyer, R., Wang, K., Yearley, A., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

PatientViewpoint: a website for patient-reported outcomes assessment. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

Filling the gaps of patient information needs and information perception in chronic myeloid leukemia with the patient-physician co-produced web-based platform CMyLife. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

ePRO symptom follow-up of colorectal cancer patients receiving oxaliplatin-based adjuvant chemotherapy is feasible and enhances the quality of patient care: a prospective multicenter study. [2023]

4. Ireland pubmed.ncbi.nlm.nih.gov

Patient-facing cancer mobile apps that enable patient reported outcome data to be collected: A systematic review of content, functionality, quality, and ability to integrate with electronic health records. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Racial differences in user experiences and perceived value of electronic symptom monitoring in a cohort of black and white bladder and prostate cancer patients. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Design of the functional requirements of a smartphone app for patients receiving oral antineoplastic agents: The e-OncoSalud® app. [2020]

7. Canada pubmed.ncbi.nlm.nih.gov

Improvement, Implementation, and Evaluation of the CMyLife Digital Care Platform: Participatory Action Research Approach. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Usability and Acceptability of the QuestLeukemia Mobile Application: A Pilot Study for An Educational and Psychological Intervention for Children with Chronic Illnesses. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Novel mobile application for direct communication between pharmacists and patients treated with oral antineoplastic agents. [2021]