Fatigue Clinical Trial
Official title:
Programs to Support You During Chemotherapy (Pro-You): Feasibility
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.The purpose of this initial feasibility study is to refine study procedures.
PRIMARY OBJECTIVES:
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 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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care
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