CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44 enrolled
Drug / intervention
Laboratory Biomarker Analysis +5 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02489422
NCT02489422N/ACompleted
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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

Wake Forest University Health Sciences·interventional·Posted Jul 3, 2015·Updated Oct 14, 2022

In Brief

A clinical study evaluating Laboratory Biomarker Analysis, Questionnaire Administration, and 4 other interventions for Depression and 20 related conditions. Completed, enrolled 44 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression, 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
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH)

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 3, 2015
Enrollment StartAug 1, 2016
Primary CompletionJan 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 11.0 years ago

Interventions

Laboratory Biomarker Analysisother

Correlative studies

Questionnaire Administrationother

Ancillary studies

Daily Survey Administrationother

Ancillary studies

Yoga Skills Trainingbehavioral

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.

Attention Controlbehavioral

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.

Actigraphy Assessmentother

Ancillary studies