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Expressive Writing in GVHD (EXPRESS-C-GVHD)

Primary Purpose

Graft Versus Host Disease

Status
Enrolling by invitation
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Expressive Writing
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graft Versus Host Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Dermatology, Northwestern University Feinberg School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Expressive writing weekly session

Arm Description

Weekly, 1-hour sessions of creative writing, discussion and social support, in a group setting via videoconference for a total of 4 sessions.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 12, 2023
Last Updated
February 23, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT05694832
Brief Title
Expressive Writing in GVHD
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 21, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Versus Host Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Expressive writing weekly session
Arm Type
Experimental
Arm Description
Weekly, 1-hour sessions of creative writing, discussion and social support, in a group setting via videoconference for a total of 4 sessions.
Intervention Type
Behavioral
Intervention Name(s)
Expressive Writing
Intervention Description
Creative writing, discussion and social support, in a group setting via videoconference
Primary Outcome Measure Information:
Title
Change in Dermatology Life Quality Index scores
Description
Measured at baseline and post completion of the 4 week expressive writing sessions
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in Short Form-36 scores
Description
Measured at baseline and post completion of the 4 week expressive writing sessions
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Choi
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology, Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Expressive Writing in GVHD

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