Mindfulness Intervention to Improve Symptomology Among Cancer Survivors; Focus on Sleep and Stress Improvement
NCT ID: NCT02633748
Last Updated: 2016-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2015-09-30
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Intervention
The twenty participants in the intervention arm will undergo a pre-assessment, post assessment, and a three month follow-up assessment. The pre and post assessments will ask participants to 1) fill out questionnaires to measure lifestyle, stress, meditations habits, and sleep impairment, 2) take a blood sample, 3) use a BodyMedia's Sensewear® armband for a week, and 4) provide salivary cortisol levels. The three month follow-up will repeat everything done if the first two assessments, excluding the blood sample. The intervention arm will also attend the weekly two and a half hour Mindfulness-Based Cancer Survivorship (MBSC) four-week program between the pre and post assessments.
Mindfulness-Based Cancer Survivorship
Mindfulness-Based Cancer Survivorship (MBCS) is a four-week standardized mindfulness program, adapted for cancer survivors from Mindfulness-Based Stress Reduction (MBSR). MBCS teaches formal mindfulness practice (meditation) and informal mindfulness during daily activities. Mindfulness has been shown to help stress, fatigue, sleep complaints, and other symptoms but has not been extensively studied in cancer survivors.
Control
The twenty participants in the control arm will undergo the same pre assessment as the intervention arm, receive a presentation on breathing exercises, and undergo the same post and three-month follow-up assessments. The control arm will also be offered the same Mindfulness-Based Cancer Survivorship program given to the intervention arm following the three month follow-up.
No interventions assigned to this group
Interventions
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Mindfulness-Based Cancer Survivorship
Mindfulness-Based Cancer Survivorship (MBCS) is a four-week standardized mindfulness program, adapted for cancer survivors from Mindfulness-Based Stress Reduction (MBSR). MBCS teaches formal mindfulness practice (meditation) and informal mindfulness during daily activities. Mindfulness has been shown to help stress, fatigue, sleep complaints, and other symptoms but has not been extensively studied in cancer survivors.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability to read, write, and understand English
* Ability to participate in a group
Exclusion Criteria
* Corticosteroid therapy greater than prednisone 25 mg per day or equivalent
18 Years
ALL
No
Sponsors
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University of Georgia
OTHER
University of South Carolina
OTHER
Prisma Health-Upstate
OTHER
Responsible Party
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Principal Investigators
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Mark O'Rourke, M.D.
Role: PRINCIPAL_INVESTIGATOR
Prisma Health-Upstate
Sara Robb, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Georgia
Michael Wirth, PhD
Role: PRINCIPAL_INVESTIGATOR
University of South Carolina
Locations
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Greenville Health System Cancer Institute Center for Integrative Oncology and Survivorship
Greenville, South Carolina, United States
Countries
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Other Identifiers
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Pro00047213
Identifier Type: -
Identifier Source: org_study_id
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