Mindfulness Interventions and Cutaneous T Cell Lymphoma (CTCL)

Not Applicable

Terminated

• Conditions: Anxiety; Quality of Life
• Interventions: Behavioral: Mindfulness-Based Stress Reduction (MBSR)

• Registration Number: NCT03174808
• Lead Sponsor: Yale University

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.

Study Timeline

• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-05-31
• Study First Posted: 2017-06-05
• Study Start: 2017-08-20
• Primary Completion: 2017-10-31
• Study Completion: 2018-11-26
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-25
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mindfulness-Based Stress Reduction (MBSR)	Mindfulness-Based Stress Reduction (MBSR)	Participants will attend group sessions led by an instructor experienced in MBSR in an academic setting.

Primary Outcome Measures

Name	Time	Method
Feasibility	16 weeks	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.
Adherence	16 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Stress	baseline, 8 weeks, and 16 weeks	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.
Quality of Life	baseline, 8 weeks, and 16 weeks	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.

Trial Locations

Locations (1)

Yale Cancer Center/Smilow; 🇺🇸 New Haven, Connecticut, United States