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Programs To Support You During Chemotherapy — PRO-YOU  

Depression Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

  • Anal Cancer
  • Anus Neoplasms
  • Appendiceal Neoplasms
  • Appendix Cancer
  • Biliary Tract Cancer
  • Biliary Tract Neoplasms
  • Colorectal Neoplasms
  • Depression
  • Esophageal Cancer
  • Fatigue
  • Gallbladder Cancer
  • Gallbladder Neoplasms
  • Gastrointestinal Stromal Cancer
  • Intestinal Neoplasms
  • Large Intestine Cancer
  • Liver Cancer
  • Pancreatic Cancer
  • Small Intestine Cancer
  • 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
  • Stomach Cancer
  • Stomach Neoplasms
Clinical Trial Details
NCT number NCT02489422
Study type Interventional
Source Wake Forest University Health Sciences
Contact
Status Completed
Phase N/A
Start date August 2016
Completion date January 2020
View Details
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