Mindfulness Intervention to Reduce Patient Reported Symptoms in Patients With Chronic Graft-Versus-Host Disease

Официальное название

Pilot Feasibility Study of Mindfulness-Based Intervention in Patients With Chronic Graft-Versus-Host Disease

Обзор

This clinical trial tests a mindfulness intervention, consisting of group sessions and an individual session, using mindfulness based stress reduction techniques, to reduce patient reported symptoms for patients with chronic graft versus host disease (cGVHD). In patients undergoing allogeneic stem cell transplant, sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). In cGVHD patients may encounter stiffness, itching, joint and muscle pain, oral cavity pain, itchy eyes, shortness of breath, depression, anxiety, and poor sleep resulting in a significant impact on patients' quality of life. Mindfulness interventions use meditation practices with elements of psychology to improve emotional regulation, resilience and acceptance based coping. This mindfulness based intervention may reduce patient reported symptoms in patients with cGVHD.

Подробное описание

PRIMARY OBJECTIVE:

I. Assess the feasibility of an 8-week mindfulness-based intervention (MBI) program consisting of weekly group sessions and a practitioner/patient 1:1 session in patients with a diagnosis of chronic graft-versus-host disease (cGVHD).

SECONDARY OBJECTIVES:

I. Determine the number of patients who withdraw consent before starting group sessions or do not attend any of the planned group sessions.

II. Assess the feasibility of daily self-meditation in patients with a diagnosis of cGVHD.

III. Estimate the preliminary efficacy of the MBI program in patients with cGVHD.

EXPLORATORY OBJECTIVE:

I. Examine potential associations between the MBI program and the following at baseline, Week 4, and at completion of the MBI program.

OUTLINE:

Patients complete group sessions once weekly (QW), on weeks 1-4, over 40 minutes, and on weeks 6-8, over 60 minutes, and an individual session, over 60 minutes, on week 5. Sessions consist of instruction on diaphragmatic breathing, body scan, visualization, and individual mediation practice. Patients are recommended to complete self mediation daily for at least 15 minutes, for 8 weeks. Patients undergo blood sample collection throughout the study.

Вмешательства

• Процедура Biospecimen Collection
  Undergo blood sample collection
• Поведенческое Mindfulness Relaxation
  Complete group mindfulness sessions
• Поведенческое Mindfulness Relaxation
  Complete individual mindfulness session
• Поведенческое Mindfulness Relaxation
  Complete daily self meditation
• Другое Survey Administration
  Ancillary studies

Первичные конечные точки

• Compliance (feasibility) [Срок оценки: Up to 8 weeks]

Вторичные конечные точки (4)

• Reason for not starting study activities after signing consent [Срок оценки: Up to 8 weeks]
• Feasibility of daily meditation in patients with a diagnosis of cGVHD [Срок оценки: Up to 8 weeks]
• Decrease of > 5 points on the 7-day Modified Lee Chronic Graft Versus Host Disease Symptom Scale (MLSS [Срок оценки: From baseline to completion of mindfulness based intervention (MBI) program, up to 8 weeks]
• Decrease in cGVHD severity stage per 2014 NIH consensus cGVHD grading criteria [Срок оценки: From baseline to completion of MBI program, up to 8 weeks]

Критерии участия

Критерии включения

• Documented informed consent of the participant and/or legally authorized representative
• Willingness to participate in the study
• Willingness to attend in-person or virtual group sessions
• Ability to read and understand English (required for protocol therapy and planned survey)
• Age: ≥ 18 years
• Confirmed diagnosis of moderate/severe chronic graft-versus-host disease by National Institute of Health (NIH) criteria
• Karnofsky performance status ≥ 80

Критерии исключения

• Previous participation in four or more sessions of mindfulness-based cognitive therapy (MBCT)/ mindfulness-based stress reduction (MBSR)
• An increase in anti-cGvHD medication (increased dosage or addition of a new medication) within 4 weeks prior to baseline evaluation
• Severe psychiatric comorbidities (active psychosis, suicidal ideation) as determined by primary investigator (PI)
• Concurrent malignancy, autoimmune disease, chronic infections, or other chronic inflammatory illness that might confound the results as determined by the PI
• Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• City of Hope Medical Center — Duarte

Идентификаторы

NCT: NCT07733141 · 25870 · NCI-2026-04201 · 25870 · P30CA033572

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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