Sleep Management in Cancer Survivors
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|ClinicalTrials.gov Identifier: NCT00935376|
Recruitment Status : Completed
First Posted : July 9, 2009
Last Update Posted : April 18, 2017
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).
|Condition or disease||Intervention/treatment||Phase|
|Insomnia||Behavioral: Sleep Education Program Behavioral: Mind-Body Bridging Program Behavioral: Mindfulness Meditation Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Pilot Study of Three Short-term Intervention Programs for Sleep Management in Cancer Survivors|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||July 2010|
Experimental: 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.
Behavioral: Mind-Body Bridging Program
Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.
Other Name: MBBP
Experimental: 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.
Behavioral: Mindfulness Meditation Program
Mindfulness Meditation Program is based on Mindfulness-Based Stress Reduction, which teaches participants awareness and mindfulness skills using techniques that include a basic meditation practice and yoga.
Other Name: MMP
Active Comparator: 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.
Behavioral: Sleep Education Program
Treatment as usual.
Other Name: SEP
- Medical Outcomes Study-Sleep Scale [ Time Frame: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up ]
- Functional Assessment of Cancer Therapy - General [ Time Frame: Pre-treatment, Post treatment, Follow up ]
- Perceived Stress Scale [ Time Frame: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up ]
- Impact of Event Scale [ Time Frame: Pre-treatment, Post treatment, Follow up ]
- Center for Epidemiologic Studies Depression Scale [ Time Frame: Pre-treatment, Post treatment, Follow up ]
- Positive Affect-Negative Affect [ Time Frame: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up ]
- Five-factor Mindfulness Questionnaire [ Time Frame: Pre-treatment, Post treatment, Follow up ]
- Self-Compassion Scale [ Time Frame: Pre-treatment, Post treatment, Follow up ]
- Well-Being Index [ Time Frame: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00935376
|United States, Utah|
|Yoshio Nakamura, Ph.D.|
|Salt Lake City, Utah, United States, 84108|
|Principal Investigator:||Yoshio Nakamura, Ph.D.||University of Utah|