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
15 participants
INTERVENTIONAL
2011-06-30
2013-07-31
Brief Summary
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Detailed Description
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I. To establish the feasibility of implementing a YST among patients undergoing chemotherapy. This includes the feasibility of implementing yoga in a treatment setting, and patient recruitment, adherence, and retention.
II. To obtain preliminary data on the efficacy of a YST for reducing fatigue among patients undergoing chemotherapy.
III. To obtain exploratory data on the impact of a YST on other treatment-related symptoms (e.g., pain, distress, nausea) and QOL.
IV. To obtain exploratory data on the impact of a YST on potential psychological (self-efficacy for coping with cancer, response expectancies for symptoms) and physiological (interleukin \[IL\]-6 \[IL-6\], IL-1 Receptor Antagonist \[IL-1Ra\], tumor necrosis factor- alpha \[TNF-a\], soluble TNF receptor I \[sTNFRI\], C-reactive protein \[CRP\]) mediators that may explain the impact of the YST on fatigue.
OUTLINE: Patients (n=20) are randomized to 1 of 2 treatment arms.
ARM I: Patients participate in three 15-minute YST sessions, comprising awareness meditation practice, movement practice, and breathing practice and relaxation. Patients also receive a compact disc (CD) recording of a 15-minute YST session and are instructed to practice the YST at home 4 times weekly.
ARM II: Patients participate in three 15-minute CE sessions, comprising empathic attention with an interventionist who allows patients to direct the flow of conversation and provides supportive comments according to standardized procedures. Patients also receive CDs with recorded information related to coping with colorectal cancer similar in length to the suggested practice time in Arm I.
The interventions (Week 2, Week 4, Week 6) and assessments (Week 0, Week 4, Week 8) are implemented during visits for chemotherapy (every two weeks).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm 1 (YST)
Patients participate in three 15-minute YST sessions, comprising awareness meditation practice, movement practice, and breathing practice and relaxation. Patients also receive a CD recording of a 15-minute YST session and are instructed to practice the YST at home 4 times weekly.
Yoga therapy
receive YST
questionnaire administration
Ancillary studies
quality-of-life assessment
Ancillary studies
laboratory biomarker analysis
Correlative studies
assessment of therapy complications
Ancillary studies
management of therapy complications
Receive YST or CE
Arm 2 (CE)
Patients participate in three 15-minute CE sessions, comprising empathic attention with an interventionist who allows patients to direct the flow of conversation and provides supportive comments according to standardized procedures. Patients also receive CDs with recorded information related to coping with colorectal cancer similar in length to the suggested practice time in Arm I.
questionnaire administration
Ancillary studies
quality-of-life assessment
Ancillary studies
laboratory biomarker analysis
Correlative studies
assessment of therapy complications
Ancillary studies
management of therapy complications
Receive YST or CE
educational intervention
Receive CE
Interventions
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Yoga therapy
receive YST
questionnaire administration
Ancillary studies
quality-of-life assessment
Ancillary studies
laboratory biomarker analysis
Correlative studies
assessment of therapy complications
Ancillary studies
management of therapy complications
Receive YST or CE
educational intervention
Receive CE
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Are diagnosed with colorectal cancer
* Recruited within 2 weeks of initiating chemotherapy (including reinitiating chemotherapy after a treatment holiday of greater than or equal to 4 weeks)
* Able to understand written and spoken English
Exclusion Criteria
* Unable to read or understand English
* Vulnerable subjects (except those who are economically or educationally disadvantaged)
18 Years
ALL
No
Sponsors
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Wake Forest University
OTHER
Responsible Party
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Principal Investigators
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Stephanie J Sohl, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest
Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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NCI-2011-01093
Identifier Type: REGISTRY
Identifier Source: secondary_id
CCCWFU 98211
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00016716
Identifier Type: -
Identifier Source: org_study_id
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