A Pilot Study of Three Short-term Intervention Programs for Sleep Management in Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Functional Assessment of Cancer Therapy - General
研究概览
简要总结
The pilot project will investigate three short-term intervention programs for sleep management in cancer survivors in a randomized controlled clinical study. Three programs to be examined in the study are:
- the mind-body bridging program (MBBP),
- mindfulness meditation program (MMP), and
- sleep education program (SEP).
详细描述
This pilot randomized study investigates whether the two awareness training programs (ATP), MBBP and MMP are effective in improving sleep disturbance and in reducing stress in post-treatment cancer patients. The two experimental conditions and the SEP control will each comprise 3 sessions of 2 hr. duration and conducted over 3 consecutive weeks (Week 1-3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Selection of subjects will be based on their exhibiting sleep disturbance as assessed by a validated sleep questionnaire (MOS Sleep Scale, Hayes et al, 2005).
- •Participant is willing to be randomized to any one of the three interventions, will be willing to attend all three classes, complete self-report questionnaires and collect saliva samples, at pre- and post- treatment, weekly intervals and 2-3 months follow-up.
- •Participant must be English speaking and comprehend information presented during the course of study, including the consent form.
排除标准
- •Underlying psychiatric illness, such as severe or untreated psychopathology (e.g. schizophrenia), or cognitive impairments, neurologic disorders, or dementia.
- •Use of psychotropic medication for any of the above, and for any other unspecified condition.
- •Has had previous exposure to MBBP or MBSR/MMP.
- •Incidence of metastatic cancer
- •Currently taking immuno-suppressants and/or corticosteroids.
- •Compromised physical health, in which individual has impaired mobility: unable to carry out movement exercises, cannot lie down on the floor, kneel, get up from the floor to a standing position.
- •Individuals who are considered at the 'end-of-life' stage of their cancer.
研究组 & 干预措施
Mind-Body Bridging Program
The Mind-Body Bridging Program (MBBP) is an awareness training program (ATP)to help individuals improve their health condition and attain a state of well-being. Bridging is the primary technique that facilitates the healing process, by bringing one back to the present moment to experience thoughts, emotions and physical sensations. Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.
干预措施: Mind-Body Bridging Program (Behavioral)
Mindfulness Meditation Program
Mindfulness Meditation Program (MMP) is based on Mindfulness-Based Stress Reduction (MBSR), which teaches participants mindfulness skills such as meditation and yoga. Mindfulness may be defined as paying attention in a particular way, on purpose, in the present moment, and nonjudgmentally. The goal of MBSR is to provide participants with experiential tools and mindfulness practices to assist them to become more mindful of themselves, others and their external environment. The techniques are easy to learn and teach individuals to be aware of the present moment, with an open mind in which they can perceive their thoughts, physical sensations, and emotions nonjudgmentally.
干预措施: Mindfulness Meditation Program (Behavioral)
Sleep Education Program
The Sleep Education Program (SEP) will serve as the control intervention in which participants will receive classes informing them how to change their habits to improve their sleep, and what to do if they have concerns about their sleep quality.
干预措施: Sleep Education Program (Behavioral)
结局指标
主要结局
Functional Assessment of Cancer Therapy - General
时间窗: Pre-treatment, Post treatment, Follow up
Medical Outcomes Study-Sleep Scale
时间窗: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up
Perceived Stress Scale
时间窗: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up
次要结局
- Impact of Event Scale(Pre-treatment, Post treatment, Follow up)
- Center for Epidemiologic Studies Depression Scale(Pre-treatment, Post treatment, Follow up)
- Positive Affect-Negative Affect(Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up)
- Five-factor Mindfulness Questionnaire(Pre-treatment, Post treatment, Follow up)
- Self-Compassion Scale(Pre-treatment, Post treatment, Follow up)
- Well-Being Index(Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up)
研究者
Yoshio Nakamura
Assistant Professor
University of Utah