Mindfulness Interventions and Cutaneous T Cell Lymphoma (CTCL)

Yale University

Status

Terminated

Conditions

Quality of Life

Anxiety

Treatments

Behavioral: Mindfulness-Based Stress Reduction (MBSR)

Study type

Interventional

Funder types

Other

Identifiers

NCT03174808

2000020161

Details and patient eligibility

About

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.

Full description

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.

Enrollment

3 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.