NCT05694832

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

January 21, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2024

Completed
Last Updated

April 30, 2025

Status Verified

February 1, 2025

Enrollment Period

1.3 years

First QC Date

January 12, 2023

Last Update Submit

April 27, 2025

Conditions

Graft Versus Host Disease

Outcome Measures

Primary Outcomes (1)

  • Change in Dermatology Life Quality Index scores

    Measured at baseline and post completion of the 4 week expressive writing sessions

    4 weeks

Secondary Outcomes (1)

  • Change in Short Form-36 scores

    4 weeks

Study Arms (1)

Expressive writing weekly session

EXPERIMENTAL

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

Interventions

Expressive WritingBEHAVIORAL

Creative writing, discussion and social support, in a group setting via videoconference

Expressive writing weekly session

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with limited level of oral and written English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Kaundinya T, Kye Y, El-Behaedi SE, Choi JN. Protocol for a feasibility trial (EXPRESS-C-GVHD) for an expressive helping intervention within a support group for cutaneous graft-versus-host-disease. Arch Dermatol Res. 2023 Dec;315(10):2905-2912. doi: 10.1007/s00403-023-02718-y. Epub 2023 Sep 12.

    PMID: 37698591DERIVED

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Jennifer Choi

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2023

First Posted

January 23, 2023

Study Start

January 21, 2023

Primary Completion

May 24, 2024

Study Completion

May 24, 2024

Last Updated

April 30, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)