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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Connecticut
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New Haven、Connecticut、美国、06511
- Yale Cancer Center/Smilow
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Mindfulness-Based Stress Reduction (MBSR)
Participants will attend group sessions led by an instructor experienced in MBSR in an academic setting.
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Participants will attend weekly 2.5-hour group sessions (of 10-14 persons) based on the standard MBSR protocol.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Feasibility
大体时间：16 weeks
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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.
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16 weeks
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Adherence
大体时间：16 weeks
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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.
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16 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Stress
大体时间：baseline, 8 weeks, and 16 weeks
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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.
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baseline, 8 weeks, and 16 weeks
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Quality of Life
大体时间：baseline, 8 weeks, and 16 weeks
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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.
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baseline, 8 weeks, and 16 weeks
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Depression
大体时间：baseline, 8 weeks, and 16 weeks
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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.
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baseline, 8 weeks, and 16 weeks
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Anxiety
大体时间：baseline, 8 weeks, and 16 weeks
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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.
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baseline, 8 weeks, and 16 weeks
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Healing
大体时间：baseline, 8 weeks, and 16 weeks
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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.
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baseline, 8 weeks, and 16 weeks
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Effect of Skin Disease
大体时间：baseline, 8 weeks, and 16 weeks
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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).
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baseline, 8 weeks, and 16 weeks
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Client Credibility
大体时间：week 1
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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.
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week 1
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Suicide Severity
大体时间：screening/baseline
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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.
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screening/baseline
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Disease Progress
大体时间：baseline, 8 weeks, and 16 weeks
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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
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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