Clinical trial NCT03174808: Mindfulness Interventions and Cutaneous T Cell Lymphoma (CTCL)
Official title: Mindfulness Interventions and Cutaneous T Cell Lymphoma (CTCL)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anxiety
Quality of Life
Keywords: cutaneous T-cell lymphoma
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: The Wallace Foundation
First posted: 2017-06-05
Enrollment: 3
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility
timeFrame: 16 weeks
measure: Adherence
timeFrame: 16 weeks
Secondary outcomes:
measure: Stress
timeFrame: baseline, 8 weeks, and 16 weeks
measure: Quality of Life
timeFrame: baseline, 8 weeks, and 16 weeks
Other outcomes:
measure: Depression
timeFrame: baseline, 8 weeks, and 16 weeks
measure: Anxiety
timeFrame: baseline, 8 weeks, and 16 weeks
measure: Healing
timeFrame: baseline, 8 weeks, and 16 weeks
measure: Effect of Skin Disease
timeFrame: baseline, 8 weeks, and 16 weeks
measure: Client Credibility
timeFrame: week 1
measure: Suicide Severity
timeFrame: screening/baseline
measure: Disease Progress
timeFrame: baseline, 8 weeks, and 16 weeks
Locations:
city: New Haven
country: United States
facility: Yale Cancer Center/Smilow
state: Connecticut
Study officials:
affiliation: Yale University
name: Eugene Shapiro, MD
role: PRINCIPAL_INVESTIGATOR
References: