Expressive Writing in GVHD (EXPRESS-C-GVHD)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Graft Versus Host Disease
• Intervention / Treatment: Behavioral: Expressive Writing

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Dermatology Clinical Trials Unit; Phone Number: 312-503-5944; Email: NUderm-research@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Department of Dermatology, Northwestern University Feinberg School of Medicine
      • Contact: Dermatology Clinical Trials Unit; Phone Number: 312-503-5944; Email: NUderm-research@northwestern.edu
      • Principal Investigator: Jennifer N Choi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Expressive Writing; Creative writing, discussion and social support, in a group setting via videoconference

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Jennifer Choi, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: January 12, 2023
• First Submitted That Met QC Criteria: January 12, 2023
• First Posted (Actual): January 23, 2023

Study Record Updates

• Last Update Posted (Actual): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease
• Other Study ID Numbers: NU 21H12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No