Programs to Support You During Chemotherapy (Pro-You)
NCT02148406 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2015-06-23
Summary
This randomized pilot clinical trial studies Yoga Skills Training or attention control in reducing fatigue and depressive symptoms during chemotherapy in patients with stage II-IV colorectal cancer. Yoga Skills Training consists of meditation, movement and breathing practices that aim to promote mindfulness and relaxation. Attention control consists of conversations with a caring professional with a recommendation to complete daily home diaries. It is not yet known whether Yoga Skills Training is better than attention control at reducing fatigue and depressive symptoms in patients undergoing chemotherapy.The purpose of this initial feasibility study is to refine study procedures.
Conditions
- Depressive Symptoms
- Fatigue
- Psychosocial Effects of Cancer and Its Treatment
- Stage IIA Colon Cancer
- Stage IIA Rectal Cancer
- Stage IIB Colon Cancer
- Stage IIB Rectal Cancer
- Stage IIC Colon Cancer
- Stage IIC Rectal Cancer
- Stage IIIA Colon Cancer
- Stage IIIA Rectal Cancer
- Stage IIIB Colon Cancer
- Stage IIIB Rectal Cancer
- Stage IIIC Colon Cancer
- Stage IIIC Rectal Cancer
- Stage IVA Colon Cancer
- Stage IVA Rectal Cancer
- Stage IVB Colon Cancer
- Stage IVB Rectal Cancer
Interventions
- BEHAVIORAL
-
Yoga Skills Training (YST)
Undergo YST
- OTHER
-
questionnaire administration
Ancillary studies
- OTHER
-
fatigue and depressive symptom assessment and management
Ancillary studies
- OTHER
-
psychological stress assessment
Ancillary studies
- OTHER
-
laboratory biomarker analysis
Correlative studies
- OTHER
-
Attention Control
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Vanderbilt-Ingram Cancer Center
lead OTHER
Principal Investigators
-
Stephanie Sohl · Vanderbilt-Ingram Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-08-31
- Primary Completion
- 2015-04-30
- Completion
- 2015-04-30
Countries
- United States
Study Locations
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