Back to resultsMindfulness Interventions and Cutaneous T Cell Lymphoma (CTCL)
Primary Purpose
Anxiety, Quality of Life
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Based Stress Reduction (MBSR)
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety focused on measuring cutaneous T-cell lymphoma
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.
Sites / Locations
- Yale Cancer Center/Smilow
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mindfulness-Based Stress Reduction (MBSR)
Arm Description
Participants will attend group sessions led by an instructor experienced in MBSR in an academic setting.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03174808
First Posted
May 31, 2017
Last Updated
November 25, 2019
Sponsor
Yale University
Collaborators
Wallace Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03174808
Brief Title
Mindfulness Interventions and Cutaneous T Cell Lymphoma (CTCL)
Official Title
Mindfulness Interventions and Cutaneous T Cell Lymphoma (CTCL)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
PI unexpectedly passed away, study closed.
Study Start Date
August 20, 2017 (Actual)
Primary Completion Date
October 31, 2017 (Actual)
Study Completion Date
November 26, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Wallace Research Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Quality of Life
Keywords
cutaneous T-cell lymphoma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness-Based Stress Reduction (MBSR)
Arm Type
Experimental
Arm Description
Participants will attend group sessions led by an instructor experienced in MBSR in an academic setting.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Stress Reduction (MBSR)
Intervention Description
Participants will attend weekly 2.5-hour group sessions (of 10-14 persons) based on the standard MBSR protocol.
Primary Outcome Measure Information:
Title
Feasibility
Description
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.
Time Frame
16 weeks
Title
Adherence
Description
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.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Stress
Description
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.
Time Frame
baseline, 8 weeks, and 16 weeks
Title
Quality of Life
Description
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.
Time Frame
baseline, 8 weeks, and 16 weeks
Other Pre-specified Outcome Measures:
Title
Depression
Description
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.
Time Frame
baseline, 8 weeks, and 16 weeks
Title
Anxiety
Description
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.
Time Frame
baseline, 8 weeks, and 16 weeks
Title
Healing
Description
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.
Time Frame
baseline, 8 weeks, and 16 weeks
Title
Effect of Skin Disease
Description
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).
Time Frame
baseline, 8 weeks, and 16 weeks
Title
Client Credibility
Description
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.
Time Frame
week 1
Title
Suicide Severity
Description
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.
Time Frame
screening/baseline
Title
Disease Progress
Description
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 .
Time Frame
baseline, 8 weeks, and 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Shapiro, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Cancer Center/Smilow
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Mindfulness Interventions and Cutaneous T Cell Lymphoma (CTCL)
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