Programs To Support You During Chemotherapy
NCT02489422 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44
Last updated 2022-10-14
Summary
This randomized pilot trial studies how well two supportive programs work for improving fatigue and depressive symptoms in patients with GI undergoing chemotherapy. Possible mediators such as psychological stress, circadian disruption, and inflammation, will also be explored.
Conditions
- Depression
- Fatigue
- Stage IIA Colorectal Cancer
- Stage IIB Colorectal Cancer
- Stage IIC Colorectal Cancer
- Stage IIIA Colorectal Cancer
- Stage IIIB Colorectal Cancer
- Stage IIIC Colorectal Cancer
- Stage IVA Colorectal Cancer
- Stage IVB Colorectal Cancer
- Pancreatic Cancer
- Esophageal Cancer
- Appendix Cancer
- Stomach Cancer
- Gallbladder Cancer
- Liver Cancer
- Small Intestine Cancer
- Large Intestine Cancer
- Anal Cancer
- Biliary Tract Cancer
- Gastrointestinal Stromal Cancer
Interventions
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- OTHER
-
Questionnaire Administration
Ancillary studies
- OTHER
-
Daily Survey Administration
Ancillary studies
- BEHAVIORAL
-
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.
- BEHAVIORAL
-
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.
- OTHER
-
Actigraphy Assessment
Ancillary studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
National Center for Complementary and Integrative Health (NCCIH)
collaborator NIH -
Wake Forest University Health Sciences
lead OTHER
Principal Investigators
-
Stephanie Sohl, MD · Vanderbilt University/Ingram Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-08-31
- Primary Completion
- 2020-01-31
- Completion
- 2020-01-31
Countries
- United States
Study Locations
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