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临床试验/NCT05694832
NCT05694832终止早期 1 期

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

Northwestern University2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2023年1月21日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
终止
入组人数
3
试验地点
2
主要终点
Change in Dermatology Life Quality Index scores

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Patients with limited level of oral and written English.

结局指标

主要结局

Change in Dermatology Life Quality Index scores

时间窗: 4 weeks

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

次要结局

  • Change in Short Form-36 scores(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Nam Choi, MD

Principal Investigator

Northwestern University

研究点 (2)

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