Study Results
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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RECRUITING
NA
356 participants
INTERVENTIONAL
2025-04-28
2030-02-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
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.
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.
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Undergoing the first in a planned tandem stem cell transplant
* Unable to provide meaningful consent (severe cognitive impairment or language difficulties)
18 Years
ALL
No
Sponsors
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Georgetown University
OTHER
Hackensack Meridian Health
OTHER
National Cancer Institute (NCI)
NIH
Northwestern University
OTHER
Responsible Party
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Christine Rini, PhD
Professor
Locations
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Georgetown University School of Medicine
Washington D.C., District of Columbia, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Hackensack Meridian Health
Nutley, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STU00221336
Identifier Type: -
Identifier Source: org_study_id
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