Programs To Support You During Chemotherapy

PRIMARY OBJECTIVES:

I. To conduct a pilot randomized controlled trial of the yoga skills training (YST) versus a
caring attention control (AC) group among 60 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.

Inclusion Criteria:

- Scheduled to receive at least 8 cycles of first-line first-line intravenous
chemotherapy treatment for colorectal 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

Exclusion Criteria:

- 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