17 Participants NeededMy employer runs this trial

Mindfulness for GVHD

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: City of Hope Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether mindfulness practices can improve the well-being of individuals with chronic graft-versus-host disease (cGVHD). cGVHD occurs when donated stem cells attack the recipient's body after a transplant, leading to issues such as pain, itching, and sleep disturbances. Participants will engage in group and individual mindfulness relaxation sessions to determine if these practices alleviate symptoms and enhance quality of life. This trial suits those diagnosed with moderate to severe cGVHD who are willing to attend sessions and can read and understand English. As an unphased trial, it offers participants a unique opportunity to explore innovative ways to manage symptoms and improve well-being.

What prior data suggests that this mindfulness intervention is safe for patients with chronic graft versus host disease?

Research shows that mindfulness activities are generally safe. Studies have found that they can lower stress and boost emotional well-being without harmful side effects. For example, people with long-term conditions like graft-versus-host disease (GVHD) often use meditation and relaxation techniques to manage stress and improve their quality of life.

Mindfulness practices, like those tested in the trial, usually include breathing exercises, meditation, and visualization. These methods are non-invasive, meaning they don't involve surgery or medication, and people usually handle them well. Research has not reported any major negative effects from these practices.

In summary, mindfulness relaxation is considered a safe way to manage symptoms and stress, especially for those with chronic health issues.12345

Why are researchers excited about this trial?

Researchers are excited about using mindfulness relaxation for GVHD (Graft-Versus-Host Disease) because it offers a new, non-pharmacological approach to managing this condition. Unlike traditional treatments that often rely on immunosuppressive drugs, mindfulness relaxation focuses on stress reduction techniques such as diaphragmatic breathing and meditation, which can potentially enhance patients' overall well-being without the side effects associated with medications. Additionally, this method encourages daily self-meditation, empowering patients to take an active role in their own care. By incorporating these holistic practices, the treatment could complement existing therapies and improve quality of life for those with GVHD.

What evidence suggests that this mindfulness intervention is effective for reducing symptoms of cGVHD?

Research has shown that mindfulness practices can reduce stress and improve quality of life for various health issues. Studies have found that these techniques ease symptoms like pain, anxiety, and depression by promoting relaxation and emotional balance. In this trial, participants will engage in mindfulness-based interventions, which may help those with chronic graft-versus-host disease (cGVHD) manage symptoms such as joint pain and trouble sleeping. Early findings suggest that meditation and breathing exercises can reduce stress and enhance emotional coping. This approach might improve overall well-being for people with cGVHD.

Who Is on the Research Team?

AS

Amandeep Salhotra

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for people who have chronic graft-versus-host disease (cGVHD) after receiving a stem cell transplant from a donor. Participants should be experiencing symptoms like pain, stiffness, or emotional distress related to cGVHD.

Inclusion Criteria

Documented informed consent of the participant and/or legally authorized representative
Willingness to participate in the study
Ability to read and understand English (required for protocol therapy and planned survey)
See 4 more

Exclusion Criteria

Severe psychiatric comorbidities (active psychosis, suicidal ideation) as determined by primary investigator (PI)
Previous participation in four or more sessions of mindfulness-based cognitive therapy (MBCT)/mindfulness-based stress reduction (MBSR)
I am able to follow all study procedures and requirements.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Mindfulness-Based Intervention

Participants complete an 8-week mindfulness-based intervention program consisting of weekly group sessions and a practitioner/patient 1:1 session. Sessions include instruction on diaphragmatic breathing, body scan, visualization, and individual meditation practice.

8 weeks
8 group sessions (in-person), 1 individual session (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the mindfulness-based intervention program

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Mindfulness Relaxation

Trial Overview

The study is testing whether mindfulness-based stress reduction—through group and individual sessions—can help reduce symptoms reported by patients with cGVHD. It also includes surveys and biospecimen collection to track changes.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Supportive care (mindfulness based intervention)Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials
614
Recruited
1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

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