Mindfulness Interventions and Cutaneous T Cell Lymphoma (CTCL)

Study Overview
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Brief Summary
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The primary objective is to assess the feasibly, adherence, and effects of mindfulness-based stress reduction (MBSR) on anxiety and health-related quality of life in adult patients with cutaneous T-cell lymphoma at the Yale Cancer Center/Smilow Cancer Hospital. Participants will attend group sessions led by an instructor experienced in MBSR in an academic setting. The mindfulness meditation group sessions will take place at the Smilow Cancer Center at the Yale New-Haven Hospital.

Detailed Description
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Participants will attend weekly 2.5-hour group sessions (of 10-14 persons) based on the standard mindfulness-based stress reduction (MBSR) protocol. Participants will be assigned home practice based on the MBSR protocol, and will be given audio recordings (MP3) to accompany and instruct in home practice. Eligible participants will attend weekly group sessions for 8 weeks and will be assessed at baseline, following cessation of the intervention (8-weeks), and 16 weeks. Outcomes will be assessed at baseline, 8 weeks, and 16 weeks. Extended effects of the intervention will be assessed at 16 weeks.

Official Title
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Mindfulness Interventions and Cutaneous T Cell Lymphoma (CTCL)

Conditions
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Anxiety, Quality of Life

Intervention / Treatment
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* Behavioral: Mindfulness-Based Stress Reduction (MBSR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Identified with lymphoma through the Yale Cancer Center Hematology Clinic. Access to mobile telephone/smartphone with text messaging plan in order to receive survey questions. Current CTCL patients in Dr. Foss's practice at the Yale Cancer Center. Exclusion Criteria: Current regular mindfulness meditation activity (weekly or more frequent practice of self-defined meditation, formalized relaxation techniques, tai chi, and meditative yoga). Inability or unwillingness to give consent. Serious illness (including mental illness/psychopathology) within 90 days prior to screening, including hospitalization for chronic disease. Determination of 'serious' will be made by PI and research team. For example, unstable asthma, cancers (except non-melanoma skin cancer and CTCL), and schizophrenia will be considered 'serious,' while stable asthma, allergic rhinitis, esophageal reflux, generalized anxiety disorder, or attention deficit disorder will not be considered 'serious. Active participation (weekly or more often) in a cancer or chronic disease support group. Active substance abusers. Current suicidal ideation, operationally defined as affirmative responses on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-Based Stress Reduction (MBSR)<br>Participants will attend group sessions led by an instructor experienced in MBSR in an academic setting. | Behavioral: Mindfulness-Based Stress Reduction (MBSR)<br>* Participants will attend weekly 2.5-hour group sessions (of 10-14 persons) based on the standard MBSR protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | Feasibility of the intervention will be assessed by the proportion of eligible patients attend the majority of the MBSR sessions (5 or more), and complete week-8 and week-16 assessments. | 16 weeks | 
| Adherence | Adherence will be tracked by assessing the actual amount of home practice in minutes per week using weekly practice logs and/or SMS (short message service)/text messaging. Adherence will be quantitatively assessed through tallying home practice time and number of intervention visits attended. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress | The Perceived Stress Scale (PSS) has been used in past Mindfulness treatment studies. The PSS is a 14-item scale that assesses perceived stress of life situations in adolescents and adults. Items are scored on a 5-point scale (0=never to 4=very often) (e.g., 'How often have you been upset because of something that happened unexpectedly?). Higher total scores indicate greater levels of perceived stress. | baseline, 8 weeks, and 16 weeks | 
| Quality of Life | The Functional Assessment of Cancer Therapy-General (FACT-G) is a cancer-focused measure of quality of life and well-being. It is a standard assessment at the Yale Survivorship clinic. It includes 27 items and encompasses 4 different indices of well-being: physical, social/family, emotional, and functional well-being and has been used to evaluate cancer-related QOL in many studies. | baseline, 8 weeks, and 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cutaneous T-cell lymphoma