Sleep Management in Cancer Survivors

Study Overview
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Brief Summary
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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: the mind-body bridging program (MBBP), mindfulness meditation program (MMP), and sleep education program (SEP).

Detailed Description
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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).

Official Title
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A Pilot Study of Three Short-term Intervention Programs for Sleep Management in Cancer Survivors

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Sleep Education Program
* Behavioral: Mind-Body Bridging Program
* Behavioral: Mindfulness Meditation Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mind-Body Bridging Program<br>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<br>* Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.<br>* Other names: MBBP;|
| Experimental: Mindfulness Meditation Program<br>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<br>* 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.<br>* Other names: MMP;|
| Active Comparator: Sleep Education Program<br>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<br>* Treatment as usual.<br>* Other names: SEP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep Management, Awareness Training Programs, Mindfulness Meditation, Mind Body Bridging