EXPRESS-C-GVHD: Expressive Writing in GVHD

Sponsor
Northwestern University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05694832
Collaborator
(none)
10
1
1
10.9
0.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Expressive Writing
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in Dermatology Life Quality Index scores [4 weeks]

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

Secondary Outcome Measures

  1. Change in Short Form-36 scores [4 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Dermatology, Northwestern University Feinberg School of Medicine Chicago Illinois United States 60611

Sponsors and Collaborators

  • Northwestern University

Investigators

  • Principal Investigator: Jennifer Choi, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jennifer Nam Choi, MD, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier:
NCT05694832
Other Study ID Numbers:
  • NU 21H12
First Posted:
Jan 23, 2023
Last Update Posted:
Jan 23, 2023
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 23, 2023