Depressive Symptoms | Programs to Support You During Chemotherapy (Pro-You)
Depressive Symptoms research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Psychosocial Effects of Cancer and Its Treatment
Stage IIA Colon Cancer
Stage IIA Rectal Cancer
Stage IIB Colon Cancer
Stage IIB Rectal Cancer
Stage IIC Colon Cancer
Stage IIC Rectal Cancer
Stage IIIA Colon Cancer
Stage IIIA Rectal Cancer
Stage IIIB Colon Cancer
Stage IIIB Rectal Cancer
Stage IIIC Colon Cancer
Stage IIIC Rectal Cancer
Stage IVA Colon Cancer
Stage IVA Rectal Cancer
Stage IVB Colon Cancer
Stage IVB Rectal Cancer
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Behavioral:Yoga Skills Training (YST)Undergo YST
Other:questionnaire administrationAncillary studies
Other:fatigue and depressive symptom assessment and managementAncillary studies
Other:psychological stress assessmentAncillary studies
Other:laboratory biomarker analysisCorrelative studies
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
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 review a handout describing the YST and to encourage patients to practice daily with strategies to increase adherence to home practice. Patients also receive an audio recording of the YST and devices to play the recording and are asked to keep a home practice log.
Arm II (attention control)Patients attend four 30-minute 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.
Start Date: August 2014
Completed Date: April 2015
Primary Outcome: Changes in fatigue (recalled)
Secondary Outcome: Changes in depressive symptoms (recalled and daily)
Study sponsors, principal investigator, and references
Principal Investigator: Stephanie Sohl
Lead Sponsor: Vanderbilt-Ingram Cancer Center
Collaborator: National Cancer Institute (NCI)