Yoga Skills Training or Attention Control for Reducing Fatigue and Depressive Symptoms During Chemotherapy in Patients With Stage II-IV Colorectal Cancer

Conditions:Colorectal Cancer, Colorectal Cancer, Colorectal Cancer, Cancer, Depression, Other Indications, Psychiatric
Therapuetic Areas:Oncology, Psychiatry / Psychology, Other
Age Range:18 - Any
Start Date:August 2014
Contact:VICC Clinical Trials Program

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Programs to Support You During Chemotherapy (Pro-You)

This randomized pilot clinical trial studies Yoga Skills Training or attention control in
reducing fatigue and depressive symptoms during chemotherapy in patients with stage II-IV
colorectal cancer. Yoga Skills Training consists of meditation, movement and breathing
practices that aim to promote mindfulness and relaxation. Attention control consists of
conversations with a caring professional with a recommendation to complete daily home
diaries. It is not yet known whether Yoga Skills Training is better than attention control
at reducing fatigue and depressive symptoms in patients undergoing chemotherapy.


I. To obtain preliminary data on the efficacy of the Yoga Skills Training (YST) for
improving the targeted outcomes (primary: fatigue; secondary: depressive symptoms) as
compared to the attention control (AC).

II. To explore potential mediators (psychological stress, circadian disruption,
inflammation) and moderators (gender, dose of the YST, outcome expectancies) of the effects
of the YST on targeted outcomes.

III. To qualitatively assess perceived efficacy of the interventions and acceptance of daily
measurement through semi-structured interviews in a subset of 20-30 participants.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (YST intervention): Patients undergo YST intervention comprising four individualized,
30 minute in-person sessions that instructs skills to enhance mindfulness and promote
relaxation during outpatient chemotherapy sessions in weeks 2, 4, 6, and 8. Patients
practice awareness - noticing the current state and establishing relaxed breathing for 5
minutes; movement - 7 minutes of gentle movements coordinated with the breath (such as
raising and lowering the arms); breathing practice - 3 minutes of inhaling cool air as if
through a straw; and meditation - 5 minutes of focus on letting go of physical and mental
tension. Patients are given a handout describing the YST and audio recording with devices to
play the recording to encourage patients to practice daily. Strategies to increase adherence
to home practice will be implemented and patients will be asked to keep home practice logs.

ARM II (attention control): Patients attend four 30-minute in-person sessions with an
interventionist in weeks 2, 4, 6, and 8. During these sessions, patients are encouraged to
discuss their experiences while receiving chemotherapy and do not receive instruction of
movement, meditation or breathing practices. Patients will also be asked to write brief
diary entries daily at home.

After completion of study, patients are followed up for 4 weeks.

Inclusion Criteria:

- Scheduled to receive first-line intravenous chemotherapy treatment for colorectal
cancer (stages II-IV)

- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 1

- Ability to understand and the willingness to sign an informed consent document
written in English

Exclusion Criteria:

- Regularly engaged (>= 3 days/week) in moderate physical activity of any kind (e.g.,
yoga) over the past 4 weeks

- Has a self-reported history of diagnosed sleep disorders (e.g., obstructive sleep
apnea, insomnia), comorbidities associated with poor sleep or fatigue (e.g., chronic
fatigue syndrome), or a job with night shifts
We found this trial at
2220 Pierce Ave
Nashville, Tennessee 37232
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
Nashville, TN
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