NCT02489422

Programs To Support You During Chemotherapy

GI 1549: PROGRAMS TO SUPPORT YOU DURING CHEMOTHERAPY (PRO-YOU) A Randomized Controlled Pilot Study of Yoga Compared to an Attention Control in Patients Receiving Chemotherapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: 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

• 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

Type	Name	Description
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

Timeline

• Start date: 2016-08-01
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2015-07-03
• Last updated: 2022-10-14
• Results posted: 2021-05-27

Locations

2 sites across 1 country: United States