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| ID | Type | Description | Link |
|---|---|---|---|
| 5R21AT002209 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mind-Body Bridging Program | Experimental | 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. |
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| Mindfulness Meditation Program | Experimental | 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. |
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| Sleep Education Program | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Education Program | Behavioral | Treatment as usual. |
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| Measure | Description | Time Frame |
|---|---|---|
| Medical Outcomes Study-Sleep Scale | Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up | |
| Functional Assessment of Cancer Therapy - General | Pre-treatment, Post treatment, Follow up | |
| Perceived Stress Scale | Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of Event Scale | Pre-treatment, Post treatment, Follow up | |
| Center for Epidemiologic Studies Depression Scale | Pre-treatment, Post treatment, Follow up | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoshio Nakamura, Ph.D. | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yoshio Nakamura, Ph.D. | Salt Lake City | Utah | 84108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23375640 | Derived | Lipschitz DL, Kuhn R, Kinney AY, Donaldson GW, Nakamura Y. Reduction in salivary alpha-amylase levels following a mind-body intervention in cancer survivors--an exploratory study. Psychoneuroendocrinology. 2013 Sep;38(9):1521-31. doi: 10.1016/j.psyneuen.2012.12.021. Epub 2013 Feb 1. | |
| 23338490 | Derived | Nakamura Y, Lipschitz DL, Kuhn R, Kinney AY, Donaldson GW. Investigating efficacy of two brief mind-body intervention programs for managing sleep disturbance in cancer survivors: a pilot randomized controlled trial. J Cancer Surviv. 2013 Jun;7(2):165-82. doi: 10.1007/s11764-012-0252-8. Epub 2013 Jan 22. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020782 | Matrix Metalloproteinases |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Mind-Body Bridging Program | Behavioral | Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body. |
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| Mindfulness Meditation Program | Behavioral | 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. |
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| 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 |
| D001523 |
| Mental Disorders |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |