Expressive Writing in GVHD

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2023

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Expressive writing weekly session
    • Weekly, 1-hour sessions of creative writing, discussion and social support, in a group setting via videoconference for a total of 4 sessions.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Dermatology Life Quality Index scores
    • Time Frame: 4 weeks
    • Measured at baseline and post completion of the 4 week expressive writing sessions

Secondary Measures

  • Change in Short Form-36 scores
    • Time Frame: 4 weeks
    • Measured at baseline and post completion of the 4 week expressive writing sessions

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Northwestern University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jennifer Nam Choi, MD, Principal Investigator – Northwestern University
  • Overall Official(s)
    • Jennifer Choi, Principal Investigator, Northwestern University
  • Overall Contact(s)
    • Dermatology Clinical Trials Unit, 312-503-5944, NUderm-research@northwestern.edu

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