Expressive Writing in GVHD

Graft Versus Host Disease Clinical Trial

— EXPRESS-C-GVHD  

Official title:

Assessing the Impact of Expressive Writing as a Nonpharmacologic Therapeutic Intervention Within a New Support Group for Patients With Cutaneous Graft-versus-Host Disease (EXPRESS-C-GVHD): A Pilot Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05694832
• Other study ID #: NU 21H12
• Status: Enrolling by invitation
• Phase: Early Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Graft Versus Host Disease
• Graft vs Host Disease

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