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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05694832
Other study ID # NU 21H12
Secondary ID
Status Enrolling by invitation
Phase Early Phase 1
First received
Last updated
Start date January 21, 2023
Est. completion date June 30, 2024

Study information

Verified date November 2023
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Graft-versus-host-disease (GVHD) is a disease phenomenon that occurs when immune cells of the donor recognize and attack healthy tissue within the transplant recipient, or host. It is ultimately the result of the same immunological mechanisms that provide benefit to patients receiving hematopoietic stem cell transplantation (HSCT). In patients with hematologic malignancies, HSCT can be therapeutic, as donor T cells recognize and mount a response against cancerous cells. HSCT is also used in the setting of certain immunodeficiencies and inborn errors of metabolism for which therapeutic benefit is found in immunologic repletion. To our knowledge, support groups have yet to be investigated in academic literature as a nonpharmacologic, therapeutic intervention for cutaneous GVHD patients to improve their distress, systemic disease, and quality of life. Given the dearth of research on nonpharmacologic therapies for cutaneous GVHD that address quality of life impairments, we seek to characterize the effect of an expressive writing and peer helping intervention contextualized within the framework of a support group. The primary goal of this study is to provide preliminary efficacy data of expressive writing as an intervention in patients with cutaneous GVHD to trial.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 10
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients must have an active or previously diagnosed chronic cutaneous graft-versus-host disease (cGVHD). - Patients must be age =18 years. - Patients must be able to write using a utensil and paper or be able to type. - Patients must have access to internet or cellular connectivity with sufficient bandwidth to participate in videoconferences (Zoom). - Patients should be able to and planning to attend all four live videoconferencing sessions for the support group via Zoom. - Patients must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: - Patients with limited level of oral and written English.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Expressive Writing
Creative writing, discussion and social support, in a group setting via videoconference

Locations

Country Name City State
United States Department of Dermatology, Northwestern University Feinberg School of Medicine Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Dermatology Life Quality Index scores Measured at baseline and post completion of the 4 week expressive writing sessions 4 weeks
Secondary Change in Short Form-36 scores Measured at baseline and post completion of the 4 week expressive writing sessions 4 weeks
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