Mindfulness Interventions and Cutaneous T Cell Lymphoma (CTCL)



Status:Active, not recruiting
Conditions:Anxiety, Anxiety, Lymphoma
Therapuetic Areas:Oncology, Psychiatry / Psychology
Healthy:No
Age Range:21 - Any
Updated:5/12/2018
Start Date:August 20, 2017
End Date:December 30, 2018

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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.

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.

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.
We found this trial at
1
site
333 Cedar Street
New Haven, Connecticut 06511
Phone: 203-737-1391
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from
New Haven, CT
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