Esophageal Cancer Clinical Trial
Programs To Support You During Chemotherapy
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.
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.
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.
Scheduled to receive first-line Fluorouracil (5FU)-based intravenous chemotherapy treatment for a gastrointestinal cancer (stages II-IV)
Have an Eastern Cooperative Oncology Group performance status of =< 1
Ability to understand and the willingness to sign and informed consent document in English
Has a self-reported history of diagnosed uncontrolled obstructive sleep apnea (ok if using CPAP), sleep-related seizures, sleep walking more than one time per week, restless leg syndrome, or a job with night shifts
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There are 2 Locations for this study
Winston-Salem North Carolina, 27157, United States
Nashville Tennessee, 37232, United States
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