NCT Number: NCT06960993
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Georgetown University School of Medicine, Washington D.C., District of Columbia, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: Baseline to 4 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.
Time frame: Baseline to 6 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.
Time frame: Baseline to 8 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.
Time frame: Baseline to 2 months post-transplant
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 4 months post-transplant
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 6 months post-transplant
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 8 months post-transplant
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
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.
Time frame: Baseline to 4 months post-transplant
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.
Time frame: Baseline to 6 months post-transplant
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.
Time frame: Baseline to 8 months post-transplant
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.
Time frame: Baseline to 2 months post-transplant
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.
Time frame: Baseline to 4 months post-transplant
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.
Time frame: Baseline to 6 months post-transplant
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.
Time frame: Baseline to 8 months post-transplant
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.
Contact information is provided by the study sponsor or research team.
Christine Rini, PhD
CONTACT
Sonia Zavala
CONTACT
Northwestern University
Other
Mosaic: RCT of a Digital Health Intervention for English- and Spanish-speaking Stem Cell Transplant Recipients
Acronym: Mosaic
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