Mindfulness Interventions and Cutaneous T Cell Lymphoma (CTCL)

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.

Study Overview

• Status: Terminated
• Conditions: Quality of Life; Anxiety
• Intervention / Treatment: Behavioral: Mindfulness-Based Stress Reduction (MBSR)

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale Cancer Center/Smilow

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	The Hospital Anxiety and Depression Scale (HADS) has been used to measure levels of anxiety and depression that a patient is experiencing. The HADS has fourteen items, seven of which relate to anxiety and other seven of which related to depression. Each item is scored on a 0-3 scale. Higher total scores indicate greater levels of perceived anxiety/depression.	baseline, 8 weeks, and 16 weeks
Anxiety	The Hospital Anxiety and Depression Scale (HADS) has been used to measure levels of anxiety and depression that a patient is experiencing. The HADS has fourteen items, seven of which relate to anxiety and other seven of which related to depression. Each item is scored on a 0-3 scale. Higher total scores indicate greater levels of perceived anxiety/depression.	baseline, 8 weeks, and 16 weeks
Healing	The Healing Encounters and Attitudes Lists (HEAL) questionnaires have been used to measure the nonspecific factors in healing process including patient-provider connection, treatment expectancy, healthcare environment, positive outlook, spirituality and attitude towards complementary and alternative medicine. The HEAL item banks comprise six subscales, each of which has 6-7 questions. Each item is scored on a 1-5 scale. The HEAL measures have been well validated in integrative medicine research.	baseline, 8 weeks, and 16 weeks
Effect of Skin Disease	The Skindex-29 profiles are a 29-item measure that assesses the symptomatic, emotional, and functional effects of skin diseases on quality of life. It is widely used in patients with nonmelanoma skin cancer including CTCL. Items are scored based on how often (Never, Rarely, Sometimes, Often, All the time) during the previous four weeks the patient experienced the effect described in each item. All responses are transformed to a linear scale of 100, varying from 0 (no effect) to 100 (effect experienced all the time).	baseline, 8 weeks, and 16 weeks
Client Credibility	The Client Credibility Questionnaire (CCQ) will be used to assess subject expectations and beliefs about the mindfulness program at baseline using a questionnaire modeled after the methods of Sherman et al. The CCQ will be administered to all subjects at the end of the first MBSR class, after the outline and rationale of the intervention has been presented. Subjects will be asked to make ratings using an 8-point Likert scale (0= not at all to 8=very much) about: (1) how logical the program seems; (2) how confident they are the program will be successful in reducing symptoms; and (3) how confident they would be in recommending the program to a friend.	week 1
Suicide Severity	Columbia-Suicide Severity Rating Scale (C-SSRS) is a 2-item, self-report questionnaire that includes items suicidal ideations in the past week and the past year. Questions include: (1) Have you wished you were dead or wished you could go to sleep and not wake up? and (2) Have you actually had any thoughts of killing yourself? Any positive (yes) responses during the past week are immediately referred to Yale-New Haven Children's Hospital.	screening/baseline
Disease Progress	The Eastern Cooperative Oncology Group (ECOG) assessment will be used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. ECOG is graded from 0 to 5. 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair; 5 = Dead .	baseline, 8 weeks, and 16 weeks

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Wallace Research Foundation
• Investigators: Principal Investigator: Eugene Shapiro, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2017
• Primary Completion (Actual): October 31, 2017
• Study Completion (Actual): November 26, 2018

Study Registration Dates

• First Submitted: May 31, 2017
• First Submitted That Met QC Criteria: May 31, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): November 27, 2019
• Last Update Submitted That Met QC Criteria: November 25, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: cutaneous T-cell lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous
• Other Study ID Numbers: 2000020161

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No