Study Results
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View full resultsBasic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2016-08-31
2020-01-31
Brief Summary
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Detailed Description
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I. To conduct a pilot randomized controlled trial of the yoga skills training (YST) versus a caring attention control (AC) group among adults with colorectal cancer (CRC) receiving chemotherapy to determine preliminary efficacy for the primary outcome of fatigue, secondary outcome of depressive symptoms, and possible mediators (i.e., psychological stress, circadian disruption, inflammation) as assessed by standard measures.
SECONDARY OBJECTIVES:
I. To measure the impact of the YST versus the AC on daily assessments of fatigue, depressive symptoms, and proposed mediators in the same trial and explore relationships among daily and standard assessments.
II. To qualitatively assess perceived efficacy of the YST and AC and acceptability of new methodology through semi-structured interviews in a subset of 20-40 participants.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (YST): Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
GROUP II (AC): Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, and 8.
After completion of study, patients are followed up at 4 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group I (Yoga Skills Training)
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
Laboratory Biomarker Analysis
Correlative studies
Questionnaire Administration
Ancillary studies
Daily Survey Administration
Ancillary studies
Yoga Skills Training
The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.
Actigraphy Assessment
Ancillary studies
Group II (Attention Control)
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
Laboratory Biomarker Analysis
Correlative studies
Questionnaire Administration
Ancillary studies
Daily Survey Administration
Ancillary studies
Attention Control
The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.
Actigraphy Assessment
Ancillary studies
Interventions
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Laboratory Biomarker Analysis
Correlative studies
Questionnaire Administration
Ancillary studies
Daily Survey Administration
Ancillary studies
Yoga Skills Training
The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.
Attention Control
The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.
Actigraphy Assessment
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have an Eastern Cooperative Oncology Group performance status of =\< 1
* Ability to understand and the willingness to sign and informed consent document in English
Exclusion Criteria
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
National Center for Complementary and Integrative Health (NCCIH)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Stephanie Sohl, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University/Ingram Cancer Center
Locations
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Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Vanderbilt-Ingram Cancer Center, Find a Clinical Trial
Other Identifiers
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NCI-2015-01042
Identifier Type: REGISTRY
Identifier Source: secondary_id
CCCWFU 01716
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00038321
Identifier Type: -
Identifier Source: org_study_id
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