Expressive Writing in GVHD (EXPRESS-C-GVHD)

Northwestern University

Status and phase: Terminated; Early Phase 1

Conditions: Graft Versus Host Disease

Treatments: Behavioral: Expressive Writing

Study type: Interventional

Funder types: Other

Identifiers

NCT05694832

NU 21H12

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Expressive writing weekly session

Experimental group

Description:

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

Treatment:

Behavioral: Expressive Writing